Relationship Between Social Support and Clinical Outcomes: An Evaluation of Participant-Nominated Treatment Supporters in the HOPE 4 Intervention
Circulation: Cardiovascular Quality and Outcomes
Abstract
BACKGROUND:
The HOPE 4 trial (Heart Outcomes Prevention and Evaluation 4) investigated the effectiveness of a comprehensive, collaborative model of care, implemented in Colombia and Malaysia, which aimed to reduce cardiovascular disease risk in individuals with hypertension. One component of this intervention was the nomination of a treatment supporter, where participants could select a family member or friend to assist them with their care. The purpose of this study was to investigate the impact of these individuals on participant outcomes, as well as the relationship dynamics between participants and their treatment supporter.
METHODS:
Participants in the HOPE 4 intervention group with baseline and 12 months of follow-up were included for analysis. They were divided into Every Visit (n=339) and <Every Visit (n=268) groups based on whether they had a treatment supporter for all 5 or for <5 follow-up visits, respectively. Outcomes were stratified between groups and tested for significance using a generalized linear mixed-effects model. A survey investigating participant satisfaction with their treatment supporter was administered at 12 months.
RESULTS:
Groups were majority female (53% versus 62%) with a mean age of 63 and 66 years. Country of origin differed between groups (22% versus 86%; Colombia). A 15.5% ([95% CI, 6.2%–24.8%] P=0.004) greater increase in statin medication use was reported in the Every Visit group at 12 months compared with the <Every Visit group. Sixty-one percent versus 48.2% of participants reported high medication adherence at 12 months (P<0.003). The difference in change in systolic blood pressure between groups was not found to be significant at 12 months, though it favored the Every Visit group (−2.3 [95% CI, −6.1 to 1.5]; P=0.045). The majority of survey respondents from either study group strongly agreed that having a treatment supporter positively influenced their health.
CONCLUSIONS:
Long-term support from a nominated treatment supporter was associated with improved adherence, risk factor management, and medication use among individuals with hypertension.
REGISTRATION:
URL: https://www.clinicaltrials.gov; Unique identifier: NCT01826019.
WHAT IS KNOWN
•
Adherence to antihypertensive medications remains a significant barrier to the control of hypertension and ultimately the burden of cardiovascular disease globally.
•
Structured support from family members or friends has demonstrated success in improving adherence to antiretroviral therapy in patients with HIV/AIDS, though it has not been widely studied in patients with hypertension.
WHAT THE STUDY ADDS
•
This process evaluation investigated the impact of participant-nominated treatment supporters on reducing cardiovascular disease risk among patients with hypertension in the context of the greater HOPE 4 (Heart Outcomes Prevention and Evaluation 4) intervention.
•
Positive trends in medication adherence and healthy lifestyle behaviors were seen among patients with consistent support over the course of our 12 month intervention strategy.
•
Treatment supporters may offer a cost-effective, scalable approach to reducing cardiovascular disease risk among patients with hypertension.
Hypertension remains a leading modifiable risk factor for cardiovascular disease (CVD) and mortality worldwide, accounting for ≈10.8 million deaths in 2019.1–3 Despite well-established treatment options and calls to improve the management of this condition, the prevalence of hypertension continues to rise globally with the majority of patients remaining uncontrolled.4,5
Management of patients with hypertension involves a combination of medications and healthy lifestyle behaviors.6 Adherence to such regimens is associated with a significant decrease in CVD risk and overall mortality.7 That said, rates of adherence remain suboptimal, with ≈50% of patients failing to adhere to their medications after 1 year of initiation.7 Intervention strategies such as SMS reminders, simplified dosing regimens, and pharmacist-based interventions have been investigated to improve adherence among patients. However, there remains no consensus as to which is the most effective for wide-scale implementation.8 Furthermore, the study of these strategies in randomized controlled trials provides limited evidence on generalizability to different health system settings.
The use of structured family support as a means of promoting adherence to medications has become a popular approach to management in patients with HIV.9–12 These individuals, also known as treatment supporters, have demonstrated to be successful in improving long-term adherence and patient attitudes to treatment.9–12 Given that the burden of hypertension remains highest in low- and middle-income countries and considering the similarities that exist between chronic disease management strategies, such an intervention may be a cost-effective, scalable approach to improving care in these populations.13–15 With the aim of addressing multiple barriers to care, treatment supporters were included as a component of our intervention strategy, HOPE 4 (Heart Outcomes Prevention and Evaluation 4), a comprehensive, collaborative model of care involving nonphysician health workers (NPHWs) and the provision of cost-free cardiovascular medications to reduce the risk of CVD in patients with newly diagnosed or poorly controlled hypertension.16 The intervention was implemented across 30 communities in Colombia and Malaysia and saw strongly positive results with participants in the intervention group experiencing a 40% greater reduction in the Framingham risk score 10-year risk estimate at 12 months compared with the control.16
Novel approaches to improving the burden of hypertension are urgently required for low- and middle-income countries. The purpose of this process evaluation was to investigate the impact of nominated treatment supporters on participant outcomes, as well as to investigate the relationship dynamics between participants and their treatment supporter in the context of the greater HOPE 4 intervention.
METHODS
The data, analytic methods, and study materials will not be made publicly available, though these may be released upon individual request. This process evaluation was embedded within the main HOPE 4 trial.16,17 The trial protocol was approved by the institutional review board or independent ethics committee of participating institutions before study initiation. All participants provided written, informed consent for the participation in this study. To ensure a comprehensive approach to analysis, we evaluated the following 4 domains, adapted from the Medical Research Council Guidance on Process Evaluations18:
1.
Implementation: to assess the degree to which the treatment supporter component of the intervention was delivered as planned.
2.
Mechanism of Impact: to assess how treatment supporters interacted with participants throughout the intervention, as well as the impact of these individuals on participant intentions to improve their health.
3.
Context: to assess the acceptability of the treatment supporter component of the intervention among participants, as well as the perceived attitudes of treatment supporters and patients alike toward the recommendations made by HOPE 4 NPHWs.
4.
Outcomes: to understand the impact of the treatment supporter component of the intervention on participant outcome measures.
Description of HOPE 4 Treatment Supporters
Informed by a series of health system appraisals,18–22 the treatment supporter component of the intervention was intended to address several patient-level barriers to care, in particular medication compliance and adherence to long-term therapies. Participants in the HOPE 4 intervention group were offered the opportunity to nominate a treatment supporter at each of the 5 scheduled NPHW visits, which occurred at baseline and 1, 3, 6, and 12 months follow-up. Visits were most commonly held at participants’ homes and less commonly at local clinics. Treatment supporter nomination was optional for participants but strongly encouraged by NPHWs. No restrictions were placed on who they selected. To ensure consistency in the education and delivery of this intervention component, NPHWs were prompted by their mHealth tablet with a definition of the treatment supporter role, which consisted of (1) reminding participants to take their medications; (2) encouraging participants to achieve the healthy lifestyle goals they set with their NPHW; and (3) reminding participants of upcoming physician appointments. It was also recommended that treatment supporters attend all scheduled study visits to remain updated on the participant’s care plan. During this time, treatment supporters were encouraged to continue supporting participants throughout their care. The hypothesized impacts of the treatment supporter role on participant outcomes are summarized in Figure 1.
Inclusion and Exclusion Criteria
A detailed description of participant eligibility criteria has been published previously in the trial’s protocol.18 In brief, individuals aged ≥50 years with newly diagnosed or poorly controlled hypertension were considered eligible for enrollment. For this process evaluation, only participants randomized to the HOPE 4 intervention group with both baseline and 12-month follow-up data were considered eligible for analysis. Groups were defined based on treatment supporter involvement. The Every Visit group included participants who had a treatment supporter for all 5 scheduled NPHW visits. The <Every Visit group included participants who either did not nominate a treatment supporter or that had one for <5 scheduled study visits.
Data Collection
Process data were collected in parallel with the main HOPE 4 trial. Figure 2 contains details regarding how data were organized for interpretation according to our 4 study domains.
Outcome data were collected by NPHWs during each scheduled follow-up visit. The primary outcome of the HOPE 4 study was the difference in change in the Framingham risk score 10-year risk estimate from baseline to 12 months between the intervention and control groups. This outcome measure has been validated in numerous ethnic groups.18 Secondary outcome measures included additional CVD risk factors such as changes in mean systolic blood pressure (SBP), low-density lipoprotein (LDL), high-density lipoprotein (HDL), and total cholesterol from baseline to 6 or 12 months. Tertiary outcomes included medication adherence at 6 and 12 months follow-up (assessed using the Morisky Medication Adherence Scale 8 in participants using antihypertensive medications), as well as changes in healthy lifestyle behaviors. A complete description of the HOPE 4 study outcomes, as well as their time of measurement, can be found in the trial’s protocol.18 Specific outcome measures were selected for investigation in this process evaluation, as informed by our study logic model (Figure 1).
To supplement the study’s outcome analysis, an optional survey was administered to participants who had a nominated treatment supporter at the 12-month follow-up visit (Supplemental Methods). Its purpose was to gain a more comprehensive understanding of the dynamic relationship between participants and their treatment supporter. Questions were designed to address the following 3 objectives: (1) to evaluate the nature and frequency of contact between participants and their treatment supporter; (2) to understand how treatment supporters may influence participant intentions to improve their health (informed by the Theory of Planned Behaviour23); and (3) to assess the attitudes of participants and their treatment supporter toward the therapies prescribed by the HOPE 4 intervention. A list of survey questions evaluating each of these 3 objectives can be found in the Methods in the Supplemental Material.
Statistical Analysis
Selected outcome data were stratified and compared between groups. Means and 95% CIs were calculated for each group based on the within-person differences between baseline and 12-month follow-up measures. Test statistic and corresponding P values were calculated to test for differences between groups, considering the 12-month follow-up as an outcome in a generalized linear mixed-effects model. Adjustments were made for baseline values, and community was included as a random intercept effect to account for the cluster-randomized design. Comparisons of medication adherence were made at 6 and 12 months and tested for significance. Further adjustments were made to account for the use of free study medications in both groups. Results were also stratified by country to compare treatment supporter effectiveness within each study setting.
Survey results were stratified in accordance with our 2 selected analysis groups, and responses were compared using descriptive statistics. Questions yielding multiple-choice responses were compared between groups using proportions. Mean levels of agreement to survey statements that utilized a 5-point Likert scale were calculated and compared between groups.
RESULTS
Outcome Analysis
Of 644 participants in the HOPE 4 intervention group, 607 (94%) were considered eligible for this analysis. Three hundred thirty-nine (56%) participants were included in the Every Visit group, and 268 (44%) participants were included in the <Every Visit group. The <Every Visit group was further stratified into groups with relative equal distribution based on the timing of treatment supporter nomination (Figure 3).
Baseline characteristics were compared between groups (Table 1). The 2 groups were similar with respect to mean SBP, Framingham risk score, as well as in the proportion of participants using antihypertensive medications. Factors such as mean age and sex varied significantly between groups. The Every Visit group contained a significantly greater proportion of participants with a history of hypertension (n=268, 79.1% versus n=191, 71.3%; P=0.027), myocardial infarction (n=20, 5.9% versus n=4, 1.5%; P=0.006), and other CVDs (n=44, 13% versus n=17, 6.3%; P=0.007), whereas the <Every Visit group contained a significantly greater proportion of smokers (n=29, 10.8% versus n=15, 4.4%; P=0.003) and participants with diabetes (n=97, 36.2% versus n=97, 28.6%; P=0.047). Of the participants, 55% (n=146) in the <Every Visit group also reported having completed their primary education or having none/unknown status with respect to their educational background compared with 80% (n=272) in the Every Visit group (P<0.001). Significant differences with respect to the country of origin were noted between groups, as Colombia contained a greater proportion of the Every Visit group, whereas Malaysia contained a greater proportion of the <Every Visit group (Table 1).
| Factors | <Every Visit group (n=268) | Every Visit group (n=339) | P value |
|---|---|---|---|
| Age, y | 63.2 (7.8) | 66.3 (9.7) | <0. 001 |
| Average SBP, mm Hg | 153.1 (15.4) | 151.2 (15.4) | 0.136 |
| Average DBP, mm Hg | 86.2 (12.1) | 83.9 (11.8) | 0.023 |
| Sex | |||
| Women | 142 (53.0) | 210 (61.9) | 0.026 |
| Location | |||
| Rural | 136 (50.7) | 117 (34.5) | <0. 001 |
| Urban | 132 (49.3) | 222 (65.5) | |
| Country | |||
| Colombia | 58 (21.6) | 290 (85.5) | <0. 001 |
| Malaysia | 210 (78.4) | 49 (14.5) | |
| Education | |||
| None/primary/unknown | 146 (54.5) | 272 (80.2) | <0. 001 |
| Secondary/high school | 112 (41.8) | 52 (15.3) | |
| Trade/college/university | 10 (3.7) | 15 (4.4) | |
| Medical history | |||
| Current smoker | 29 (10.8) | 15 (4.4) | 0.003 |
| Diabetes | 97 (36.2) | 97 (28.6) | 0.047 |
| History of hypertension | 191 (71.3) | 268 (79.1) | 0.027 |
| Atrial fibrillation | 2 (0.7) | 9 (2.7) | 0.124 |
| Stroke | 3 (1.1) | 11 (3.2) | 0.105 |
| MI/heart attack | 4 (1.5) | 20 (5.9) | 0.0057 |
| Congestive heart failure | 8 (3.0) | 19 (5.6) | 0.120 |
| CVD (stroke/MI/angina/CHF) | 17 (6.3) | 44 (13.0) | 0.007 |
| Laboratory measures, mmol/L | |||
| Total cholesterol | 5.29 (1.13) | 5.40 (1.27) | 0.267 |
| LDL | 3.23 (1.05) | 3.42 (1.19) | 0.040 |
| Glucose | 6.86 (3.19) | 6.20 (2.74) | 0.006 |
| Baseline medication use | |||
| Antihypertensive medications | 183 (68.3) | 251 (74.0) | 0.119 |
| 1 antihypertensive medication | 86 (47.0) | 112 (44.6) | 0.624 |
| 2 antihypertensive medications | 63 (34.4) | 84 (33.5) | 0.835 |
| 3 antihypertensive medications | 22 (12.0) | 47 (18.7) | 0.059 |
| ≥4 antihypertensive medications | 12 (6.6) | 8 (3.2) | 0.098 |
| Statin medications | 98 (36.6) | 81 (23.9) | 0.001 |
| Framingham risk score 10-y risk estimate | |||
| Average CVD risk (10 y), % | 33.7 (23.1) | 31.3 (19.6) | 0.176 |
CHF indicates congestive heart failure; CVD, cardiovascular disease; DBP, diastolic blood pressure; LDL, low-density lipoprotein; MI, myocardial infarction; and SBP, systolic blood pressure.
A summary of treatment supporter characteristics at the 12-month follow-up visit can be found in Table 2. Most treatment supporters were first-degree relatives of the participant, including spouses (18.4% husbands and 29.9% wives), sons (9.5%), and daughters (24.2%). Only 6% of the treatment supporters were reported as friends of the participant.
| Treatment supporters at 12 mo | |
|---|---|
| Husband | 87 (18.4) |
| Wife | 141 (29.9) |
| Son | 45 (9.5) |
| Daughter | 114 (24.2) |
| Mother | 12 (2.5) |
| Brother | 6 (1.3) |
| Sister | 17 (3.6) |
| Daughter-in-law | 8 (1.7) |
| Son-in-law | 1 (0.2) |
| Granddaughter | 5 (1.1) |
| Grandson | 2 (0.4) |
| Friend | 29 (6.1) |
| Other | 5 (1.1) |
There was a 15.5% (95% CI, 6.2%–24.8%) greater increase in statin medication use from baseline to 12 months in the Every Visit group compared with the <Every Visit group (P=0.004). Similar trends, although not statistically significant, were noted in the Every Visit group with regard to the use of ≥2 antihypertensive medications (Table 3). Changes in SBP, total cholesterol, and glucose levels were not found to be significant between groups, though trends favored the Every Visit group at 12 months (Table 3). There was no difference in the change in LDL between groups at 12 months. The change (−0.2% [95% CI, −2.9% to 2.5%]) in the Framingham risk score 10-year risk estimate was slightly greater in the Every Visit group compared with the <Every Visit group at the end of the trial, though the difference between groups was not found to be significant (P=0.606).
| Outcome | Baseline | Change at 12 mo from baseline* | Test between groups† | |||
|---|---|---|---|---|---|---|
| <Every Visit group (n=268) | Every Visit group (n=339) | <Every Visit group (n=268) | Every Visit group (n=339) | Differences | P value | |
| Statin use, n (%) | 98 (36.4) | 81 (23.9) | 45.6 (38.1 to 53.1) | 61.1 (54.0 to 68.2) | 15.5 (6.2 to 24.8) | 0.004 |
| Use of ≥2 antihypertensive medications, n (%) | 97 (53.0) | 139 (55.4) | 29.6 (21.8 to 37.3) | 30.4 (23.5 to 37.3) | 0.9 (−9.2 to 10.9) | 0.565 |
| SBP, mm Hg; mean (SD) | 153.14 (15.39) | 151.22 (15.36) | −20.0 (−23.0 to −16.2) | −22.3 (−26.1 to −8.5) | −2.3 (−6.1 to 1.5) | 0.045 |
| Controlled SBP <140 mm Hg, n (%) | 35 (13.0) | 34 (10.0) | 65.8 (56.5 to 75.1) | 71.5 (62.3 to 80.6) | 5.7 (−3.7 to 15.0) | 0.160 |
| LDL, mmol/L; mean (SD) | 3.23 (1.05) | 3.42 (1.19) | −0.6 (−0.8 to −0.3) | −0.6 (−0.8 to −0.3) | 0.0 (−0.2 to 0.2) | 0.601 |
| Total cholesterol, mmol/L; mean (SD) | 5.29 (1.13) | 5.40 (1.27) | −0.6 (−0.8 to −0.4) | −0.7 (−0.9 to −0.5) | −0.1 (−0.3 to 0.1) | 0.511 |
| Glucose, mmol/L; mean (SD) | 6.86 (3.19) | 6.20 (2.74) | −0.0 (−0.4 to 0.4) | 0.0 (−0.3 to 0.3) | 0.0 (−0.5 to 0.5) | 0.180 |
| Cholesterol-based INTERHEART risk score | 11.73 (5.58) | 11.92 (4.83) | −4.3 (−5.1 to −3.5) | −5.0 (−5.7 to −4.2) | −0.7 (−1.6 to 0.2) | 0.185 |
| Non–laboratory-based INTERHEART risk score | 13.66 (5.62) | 13.81 (5.00) | −4.5 (−5.9 to −3.2) | −4.7 (−6.1 to −3.4) | −0.2 (−1.2 to 0.9) | 0.514 |
| Average CVD risk (10 y), % | 33.67 (23.10) | 31.32 (19.58) | −10.3 (−12.5 to −8.1) | −10.5 (−12.6 to −8.4) | −0.2 (−2.9 to 2.5) | 0.606 |
CVD indicates cardiovascular disease; LDL, low-density lipoprotein; and SBP, systolic blood pressure.
*
The means and 95% CIs are for the within-person differences.
†
Test statistic and corresponding P value refers to the test of the difference between the Every Visit and <Every Visit groups at 12 mo of follow-up using a generalized linear mixed-effects model adjusting for baseline value and including the community as a random intercept effect to take into account the clustered randomization design.
Treatment supporters appeared to positively influence several healthy lifestyle behaviors, as the Every Visit group saw favorable changes with respect to the consumption of fried/fast foods, daily meat consumption, and the proportion of participants feeling work or home stress (Table 4). Only improvements in the consumption of fruits daily reached statistical significance. Medication adherence was also significantly improved among participants with a consistent treatment supporter, as a greater proportion of participants in the Every Visit group reported high levels of adherence to antihypertensive medications at 6 months (n=199, 61.0% versus n=108, 48.2%; P<0.003) and 12 months (n=226, 68.5% versus n=125, 51.2%; P<0.0001) follow-up compared with the <Every Visit group (Table 5).
| Outcome | Baseline | Change at 12 mo from baseline* | Test between groups† | |||
|---|---|---|---|---|---|---|
| <Every Visit (n=268) | Every Visit (n=339) | <Every Visit (n=268) | Every Visit (n=339) | Differences | P value | |
| Consumes vegetables daily, n (%) | 226 (84.0) | 256 (75.5) | 16.6 (6.5 to 26.7) | 12.0 (2.1 to 22.0) | −4.6 (−13.5 to 4.3) | 0.640 |
| Consumes fruits daily, n (%) | 174 (64.7) | 221 (65.2) | 19.2 (3.9 to 34.4) | 21.6 (6.5 to 36.7) | 2.5 (−8.5 to 13.4) | 0.018 |
| Consumes salty food daily, n (%) | 66 (24.5) | 69 (20.4) | −16.2 (−26.7 to −5.6) | −14.2 (−24.6 to −3.7) | 2.0 (−7.3 to 11.3) | 0.263 |
| Consumes fried/fast food ≥3× per wk, n (%) | 103 (38.3) | 89 (26.3) | 1.8 (−12.5 to 16.2) | −2.5 (−16.7 to 11.7) | −4.3 (−15.9 to 7.3) | 0.120 |
| Consumes meat/poultry daily, n (%) | 69 (25.7) | 82 (24.2) | −3.9 (−20.2 to 12.5) | −6.1 (−22.4 to 10.2) | −2.2 (−13.0 to 8.6) | 0.977 |
| Felt work or home stress, n (%) | 56 (20.8) | 118 (34.8) | −18.8 (−30.4 to −7.3) | −21.3 (−32.7 to −9.8) | −2.4 (−12.3 to 7.4) | 0.511 |
| Felt sad, blue, or depressed, n (%) | 32 (11.9) | 62 (18.3) | −7.7 (−19.7 to 4.3) | −5.3 (−17.2 to 6.6) | 2.4 (−6.6 to 11.3) | 0.577 |
| Current smoker, n (%) | 29 (10.8) | 15 (4.4) | −1.8 (−4.5 to 1.0) | −1.0 (−3.6 to 1.6) | 0.8 (−2.7 to 4.2) | 0.660 |
*
The means and 95% CIs are for the within-person differences.
†
Test statistic and corresponding P value refers to the test of the difference between the Every Visit and <Every Visit groups at 12 mo of follow-up using a generalized linear mixed-effects model adjusting for baseline value and including the community as a random intercept effect to take into account the clustered randomization design.
| Adherence at 6-mo follow-up | |||
| ≤Every Visit group (n=248) | Every Visit group (n=336) | P value | |
| MMAS-8 score, mean (SD) | 6.9 (1.5) | 7.2 (1.2) | 0.0104 |
| High adherence* | 108 (48.2) | 199 (61.0) | 0.0030 |
| Adherence at 12-mo follow-up | |||
| <Every Visit group (n=268) | Every Visit group (n=339) | P value | |
| MMAS-8 score, mean (SD) | 7.2 (1.09) | 7.4 (1.2) | 0.0269 |
| High adherence | 125 (51.2) | 226 (68.5) | <0.0001 |
MMAS-8 indicates eight-item Morisky Medication Adherence Scale.
*
High adherence defined as an MMAS-8 score of 8.
Analysis by country revealed some statistically significant variations in results. In Colombia, the Every Visit group saw a significant increase in the use of statin medications (Tables S1 and S2), whereas in Malaysia, the Every Visit group saw a significant reduction in SBP throughout the intervention (Tables S3 and S4). An analysis adjusting for the use of free study medications can be found in the article’s Supplemental Material (Table S5).
Treatment Supporter Survey
Three hundred fifty-five participants took part in the treatment supporter survey, of whom 286 (81%) were from the Every Visit group and 69 (19%) were from the <Every Visit group. Most respondents (n=307, 86%) lived in the same household as their treatment supporter. Furthermore, only 8% (n=22) of respondents from the Every Visit group and 13% (n=9) of respondents from the <Every Visit group indicated that their treatment supporter had a previous background in a health care profession.
With respect to our first survey objective, respondents were asked to indicate the types of support they received from their treatment supporter from a list of possible response options. The most commonly selected statement among participants in either group was that their treatment supporter reminded them to take their medications (Table S6). The majority of participants in the Every Visit group, but not in the <Every Visit group, also reported that their treatment supporter encouraged them to work toward achieving their health care goals and reminded them of upcoming physician appointments.
For our second survey objective, mean levels of agreement with statements evaluating participant attitudes, subjective norms, and perceived behavioral control were consistently higher in the Every Visit group compared with the <Every Visit group (Table S7). These results were demonstrated by a greater overall mean intention score seen among participants in the Every Visit group (4.80 [SD, 0.49]) compared with the <Every Visit group (4.41 [SD, 0.90]).
Under our third survey objective, respondents were asked to select a statement from a list of possible responses that they felt best reflected their attitudes toward the HOPE 4 intervention. Of all survey respondents, 99% (n=351) selected that the HOPE 4 intervention would positively affect their health. Subsequently, when asked to select a statement from the perspective of their treatment supporter, 99% (n=351) of respondents indicated that their treatment supporter believed that the HOPE 4 intervention would favorably affect their health.
DISCUSSION
The primary finding of this process evaluation was that long-term support from a nominated treatment supporter was associated with positive trends in risk factor management, namely statin medication use and medication adherence among participants in the HOPE 4 intervention. Participants with a consistent treatment supporter also appeared to demonstrate greater intentions to improve their health.
There are few studies that have evaluated the impact of participant-nominated treatment supporters on adherence to CVD medications and related healthy lifestyle behaviors. A 2017 cluster-randomized controlled trial conducted by Shen et al24 investigated the impact of family-based supervision on adherence to BP monitoring and CVD medications among individuals with uncontrolled hypertension in rural China. The trial reported significantly greater increases in both of these factors from baseline to 6 months follow-up in the treatment group compared with the control, though changes were not found to be significant between groups at 12 months. A cluster-randomized controlled trial by Wei et al25 also incorporated treatment supporters as one component of a multifaceted intervention strategy designed to reduce CVD risk among individuals with diagnosed hypertension in rural China. A recently published process evaluation of this trial noted that participants found daily reminders from their treatment supporter to have a positive impact on medication adherence and healthy lifestyle behaviors.26 However, the study did not evaluate the direct impact of these individuals on participant cardiovascular outcomes, thereby making it difficult to interpret the results of their trial in the context of this intervention component. To the best of our knowledge, the HOPE 4 evaluation reported here is the first process evaluation to comprehensively evaluate both the impact of nominated treatment supporters on participant cardiovascular outcomes and the relationship dynamics between participants and their treatment supporter.
The treatment supporter component of the intervention was implemented with high fidelity overall, as 94% (n=568) of participants included in our analysis chose to nominate a treatment supporter. That said, we noted a difference in the rate at which it was adopted by participants in either study setting. Despite consistent education and counseling by NPHWs, the majority of participants who nominated a treatment supporter during the first study visit were from Colombia, whereas the majority of participants who nominated a treatment supporter at a later visit were from Malaysia. This result may reflect differences in the way in which either culture engages with their social networks,27 though it still supports the acceptability of this intervention strategy among participants.
Limited knowledge and awareness of hypertension are 2 of the most common barriers to care for CVD in low- and middle-income countries.28 Previously conducted health system appraisals involving communities from Colombia and Malaysia revealed that individuals with diagnosed hypertension may refrain from initiating antihypertensive medications for fear of adverse side effects or may stop their medications once symptoms appear to subside.20,29 Such misperceptions may be perpetuated by family members,30 and thus proper education is vital when considering their role as treatment supporters. The need for education and role-specific guidance for family members was recognized by Shen et al24 as their intervention offered training sessions for supporters and patients. In our intervention, treatment supporters were encouraged to attend NPHW visits where they were guided with respect to their role, encouraged to support participants, and educated on the importance of medication adherence and leading a heart healthy life. The success of this counseling may be supported by the results of our survey, as 99% (n=351) of all survey respondents indicated that their treatment supporter displayed high levels of confidence toward the therapies prescribed by the HOPE 4 intervention. Furthermore, with respect to role-specific guidance, the majority of participants from the Every Visit group indicated that their supporter reminded them to (1) take their medications (n=225, 79%), (2) attend upcoming physician appointments (n=204, 71%), and (3) meet their healthy lifestyle goals (n=205, 72%), all actions that directly correspond with the definition provided to NPHWs detailing the treatment supporter role. These same results were not seen in the <Every Visit group, possibly reflecting the delayed timing of their nomination.
Interpreting the results of our process evaluation within a framework of the Theory of Planned Behaviour23, consistent support from a family member or friend was positively correlated with greater participant intentions to improve their health. First, with respect to subjective norms, participants in the Every Visit group reported higher levels of perceived social support from their treatment supporter compared with those in the <Every Visit group, a factor that has been demonstrated to improve medication adherence, as supported by our study.31 Second, with respect to attitudes, respondents from the Every Visit group agreed more strongly with the statement that having a treatment supporter throughout the intervention improved their health, possibly reflecting the greater degree of involvement noted among treatment supporters in this group. Third, with respect to perceived behavioral control, participants in the Every Visit group reported overall greater levels of confidence to take control of various aspects of their health.
Participants in the Every Visit group demonstrated significantly higher levels of adherence to antihypertensive medications at 6 and 12 months follow-up compared with the <Every Visit group. Changes in SBP favored the Every Visit group, though no significant difference was found between groups at 12 months. With respect to medication use, a significantly greater proportion of participants in the Every Visit group reported using statin medications at 12 months compared with the <Every Visit group. That said, there was no difference in change in LDL between groups at the end of the trial. This result may reflect lower levels of adherence to statin medications among participants in this group, differences in baseline characteristics, or lifestyle behaviors. It is also possible that participants in this group may have begun using statin medications at a later point in the trial, leaving little time to see the respective decrease in LDL.
Regarding changes in healthy lifestyle behaviors, although trends favored a long-term treatment supporter, only changes in the consumption of fruits daily reached statistical significance. Behaviors such as smoking status and the consumption of salty foods were not positively influenced by treatment supporters. Similar results were seen in the trial by Wei et al,26 as some participants found it difficult to quit smoking despite consistent reminders from their treatment supporter. Interviews with participants and providers revealed this to be due to treatment supporters not carrying an influential position within the household. Although our survey found participants to have a positive therapeutic relationship with their supporter, other context-specific social factors may have limited improvements in healthy lifestyle changes. More in-depth education and counseling may be required for participants and treatment supporters alike to address such barriers.
This process evaluation had several limitations. First, our study was exploratory, involved a nonrandomized population, and was not formally powered. Thus, future studies are needed as definite conclusions cannot be drawn from our data. Second, stratified analyses were performed to address imbalances with respect to participants’ country of origin between groups. Subgroups within each country, however, varied greatly with respect to size, making it difficult to draw accurate comparisons between groups. Third, the response rate to the treatment supporter survey was only 63% (n=355). Given that participation in this survey was optional for participants, those who took part in this survey may have been more concerned about their health than nonresponders, thereby reducing the generalizability of these results to the entire study population. Furthermore, there was an imbalance regarding survey participation between the 2 groups, as the Every Visit group accounted for ≈81% (n=286) of all survey respondents, limiting our ability to test for differences between groups. It is also possible that some treatment supporters may have been present at the time of survey completion during the last follow-up visit, possibly influencing these results. Finally, 85% (n=229) of the participants included in our defined control group (<Every Visit group) nominated a treatment supporter at some point over the course of the intervention, a factor that likely minimized the effect of our intervention. This also prevented us from comparing participants who had or did not have a treatment supporter over the course of the trial. Although continuity with the same treatment supporter was stressed by NPHWs, possible changes in treatment supporters were not captured in our study.
Overall, we demonstrated that nominated treatment supporters have the potential to positively influence medication use and adherence among patients with hypertension. This strategy was evaluated within 2 countries with different health systems and cultures and was accepted by participants in both. The treatment supporter strategy is cost-effective, scalable, and has the potential to be adapted to varying contexts as a means of reducing several patient-level barriers to care of CVD and other chronic diseases.
ARTICLE INFORMATION
Supplemental Material
Supplemental Methods
Tables S1–S7
Acknowledgments
The authors acknowledge the important contributions of the late Prof Khalid Yusoff, MBBS, National Leader of the HOPE 4 study (Heart Outcomes Prevention and Evaluation 4) in Malaysia, long-time collaborator and colleague, and formerly of the Faculty of Medicine, Universiti Teknologi MARA, Selayang, Selangor, Malaysia, and the Faculty of Medicine and Health Sciences, UCSI, Kuala Lumpur, Malaysia.
Footnote
Nonstandard Abbreviations and Acronyms
- CVD
- cardiovascular disease
- HDL
- high-density lipoprotein
- HOPE 4
- Heart Outcomes Prevention and Evaluation 4
- LDL
- low-density lipoprotein
- NPHW
- nonphysician health worker
- SBP
- systolic blood pressure
Supplemental Material
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© 2024 American Heart Association, Inc.
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Received: 20 June 2022
Accepted: 4 December 2023
Published online: 5 March 2024
Published in print: April 2024
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Disclosures
Disclosures Dr Schwalm, Dr McCready, Dr Islam, and Dr Yusuf report that their institution received grants from the Canadian Institutes of Health Research, Ontario Ministry of Health and Long-Term Care, Boehringer Ingelheim, and the Department of Management of Non-Communicable Diseases, World Health Organization, for the conduct of the study. Dr Lopez-Jaramillo reports that his institution received unrestricted grants from Grand Challenges Canada, and the Santander Departmental Secretary of Health, during the conduct of the study. Dr McKee reports that his institution received a grant from the Canadian Institutes of Health Research.
Sources of Funding
This work was supported by the Canadian Institutes of Health Research (CIHR), Grand Challenges Canada (GCC), as part of the Global Alliance for Chronic Disease program (CIHR grant number: 120389; GCC grant numbers: 0069-04 and 0070-04); CIHR’s Strategy for Patient Oriented Research, through the Ontario SPOR Support Unit, as well as the Ontario Ministry of Health and Long-Term Care; an unrestricted grant from Boehringer Ingelheim; the Department of Management of Non-Communicable Diseases, World Health Organization; the Santander Departmental Secretary of Health, Bucaramanga, Colombia; and the Population Health Research Institute. The authors are solely responsible for the design and conduct of this study, all study analyses, the drafting and editing of this article, and its final contents. The funders had no role in data collection, analysis, interpretation, writing of the manuscript, or the decision to submit. No medical writers were paid to write this article by a pharmaceutical company or other agency. The corresponding author had full access to all the data in the study.
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- Pathways to Hypertension Control: Unfinished Journeys of Low‐Income Individuals in Malaysia and the Philippines, The International Journal of Health Planning and Management, (2024).https://doi.org/10.1002/hpm.3889
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