Hypertension (HTN)
Conditions
Keywords
hypertension, primary care, integrated behavioral health, dyadic intervention
Brief summary
The researchers will invite 30 patients in primary care who have high blood pressure to participate in this health program with a supportive partner of their choosing (these will be the "participant pairs"). Participant pairs will be invited to complete the Heart Care Pairs health program that will include up to six sessions each including 1) some education on a health habit like physical activity and heart healthy foods, 2) goal setting together, and 3) talk about healthy communication to support one another with heart healthy habits. The researchers will work with participants to address things that get in the way of coming for visits like offering transportation and offering telehealth visits. The researchers are seeing how this program works in real life so participants will be asked to complete as many sessions as they want to and can attend. The researchers will be interested in what participants think about the sessions, if they were satisfied with the visits, and if they would recommend the program to others in their community. The researchers will ask these questions in interviews with participants. The researchers will also ask up to 25 primary care workers about how they view the program as helpful to their work with patients with high blood pressure and whether they would refer more patients to the program in the future.
Detailed description
The overall objective of the present pilot behavioral trial is to assess the feasibility and acceptability of a dyadic CVD risk reduction intervention to be delivered by behavioral health consultants in primary care practices for patients with HTN. In a preliminary investigation prior to this pilot project, the research team has confirmed feasibility of recruitment of dyads from primary care settings, assessed health and social support needs, and interest in an intervention like Heart Care Pairs while making ongoing systematic adaptations to the intervention. The next phase of pilot work outlined in this proposal will assess if the intervention will work in primary care by assessing retention, treatment process, and acceptability. Aim 1: To determine the feasibility and acceptability of the Heart Care Pairs intervention with N=30 dyads including patients with HTN attending primary care and their chosen supportive partner using a mixed methods single-arm pragmatic trial. Hyp 1: Heart Care Pairs will be feasible based on dyads attending \<70% of intervention sessions, completion of follow-up assessments and interviews, and overall patient- and partner-reported satisfaction with the intervention. Aim 2: To assess primary care workflow and PCP acceptability of making referrals to a dyadic behavioral health intervention. Hyp 2: PCPs will agree that they referred patients to the Heart Care Pairs intervention and that the availability of the referral is helpful for their practice.
Interventions
BEHAVIORALDyadic lifestyle intervention for CVD risk reduction
This is a 6-session behavioral intervention delivered in primary care. The 6 educational topics include: 1) DASH diet; 2) Physical activity; 3) Stress management; 4) Healthy sleep habits; 5) Substance cessation (optional); 6) Adherence to medications and lifestyle habits. All sessions will include collaborative goal setting. And each educational topic will be paired with a communication skill: 1) Seeing others' perspectives; 2) Minimize efforts to control; 3) Non-judgmental language; 4) Support movement towards change; 5) Addressing relapse; and 6) Empathetic responding and self-advocacy.
Sponsors
University of Alabama at Birmingham
National Institute on Minority Health and Health Disparities (NIMHD)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
One armed behavioral pilot feasibility trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with hypertension and/or taking blood pressure lowering medications * willing to invite a supportive partner to participate for the duration of the study including an enrollment and baseline measurement visit, up to 6 intervention visits, and a post-intervention measurement visit.
Exclusion criteria
* untreated serious mental illness or cognitive decline that would limit ability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion of follow-up assessments | Immediately post-intervention | Number of surveys and interviews completed |
| Time to complete recruitment | From study start to end of recruitment, an average of 6 months | Time from posting recruitment materials to enrollment of 30 dyads |
| Responsiveness to change on survey measures | Baseline to immediately post-intervention - approximately 12 weeks | Change scores between baseline assessment to follow-up assessment |
| Attendance to intervention sessions | Baseline to immediately post-intervention - approximately 12 weeks | Number of sessions attended compared to number of sessions missed |
| Treatment Satisfaction Questionnaire | Immediately post-intervention | Participant ratings of satisfaction with the HCPs intervention. 9-items, with responses on a scale from 1-7. Some items assess satisfaction (1=extremely dissatisfied to 7=extremely satisfied), confidence (1=not at all confident, 7=extremely confident, certainty (1=not at all certain, 7=extremely certain), how easy to use/do the intervention was (1=extremely difficult, 7=extremely easy). Mean scores will be calculated for min score=1 and max score of 7. Higher scores indicate greater satisfaction, and lower burden with the intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health-related quality of life (HRQoL) | Baseline and immediately post-intervention | 1-item self-rated health status (Bullinger, 1996; Dumas, et al, 2020) |
| Perceived Stress Scale - 10 | Baseline and immediately post-intervention | 10-item Perceived Stress Scale (PSS-10; Roberti, et al, 2006). Responses range from 0=Never to 4=Very often. Scores are summed for total perceived stress score ranging from 0-40 with higher scores meaning higher perceived stress. |
| Smoking status | Baseline and immediately post-intervention | 1-item cigarette smoking status and number cigarettes per day |
| Patient Health Questionnaire - 9 | Baseline and immediately post-intervention | PHQ-9 depression screen (Kroenke, et al, 2001). Respondents endorse symptoms of depression over the past 2 weeks on a scale from 0=not at all to 3=nearly everyday. Scores are summed for total scores ranging from 0 to 27 with higher scores indicating greater severity of depression symptoms. |
| Generalized anxiety disorder (GAD)-7 | Baseline and immediately pot-intervention | GAD-7 screen for anxiety symptoms (Spitzer, et al., 2006). Respondents endorse symptoms of anxiety over the past 2 weeks on a scale from 0=not at all to 3=nearly everyday. Scores are summed for total scores ranging from 0 to 21 with higher scores indicating greater severity of anxiety symptoms. |
| Body mass index | Baseline and immediately post-intervention | Approximation of body size based on clinic measured height and weight |
| Mediterranean Eating Pattern Assessment (MEPA) | Baseline and immediately post-intervention | Brief assessment of heart healthy eating, self-report recall for past week,16 items. Items assess self-reported number of servings per type of food in the past week. Items are scored based on thresholds meeting a mediterranean diet eating pattern (e.g., greater than or equal to 2 servings of vegetables per day). Scores range from 0-16 with higher scores being more adherent to mediterranean diet pattern (more heart healthy diet). |
| International physical activity questionnaire short form (IPAQ-SF) | Baseline and immediately post-intervention | Self-reported walking, moderate physical activity, vigorous physical activity, and sedentary time, 7-items (Lee, et al, 2011). Total met minutes are calculated for each activity domain. Walking MET minutes = 3.3\*walking days\* walking minutes. Moderate MET minutes = 4.0\*moderate days\*moderate minutes. Vigorous MET minutes=8.0\*vigorous days\*vigorous minutes. Total MET minutes = Waling MET min+Moderate MET min+Vigorous MET min. |
| Sleep time | Baseline and immediately post-intervention | 1-item total average sleep time (Lloyd-Jones, et al, 2022) |
| Adherence self-report questionnaire (ASRQ) | Baseline and immediately post-intervention | Self reported medication adherence to blood pressure medicines (Zeller, et al., 2008) 1-item with 1=take all BP medications at the same time every day (excellent adherence) to 6=Hardly take any BP medications (poor adherence). |
| Treatment Self Regulation Questionnaire | Baseline and immediately post-intervention | Measure of autonomy, self-report 19-tems (Levesque, et al, 2007). 19-items assessed using a Likert-type scale from 1=Not at all true to 7=Very true. Mean of scores will be calculated with higher score meaning greater autonomy over heart healthy behaviors (taking medications, healthy diet, exercise). |
| Important other climate questionnaire | Baseline and immediately post-intervention | Measure of autonomy support, self-report 6-items (Williams, 2006). Responses are on a Likert Scale. Mean scores will be calculated with higher scores indicating greater support from "important others" with efforts to lower blood pressure. |
| Social Support for Diet and Exercise Behaviors | Baseline and immediately post-intervention | Social support from family, friends, supportive other related to healthy diet and exercise behavior (Sallis, et al., 1987). Responses range from 0=Rarely to 3=very often. Each question will be asked for "Family," "Friends," and "Study Partner." Mean scores for each relationship type will be calculated with higher scores indicate greater support with health behavior. |
| Medical Outcomes Study (MOS) Social Support Survey | Baseline and immediately post-intervention | A total of 19-items self-report for measures of global social support and subscales for: emotional/informational, tangible, affectionate, and positive social interaction. Responses to items range from 1=none of the time to 5=all of the time. The mean items responses are taken for each subscale with higher scores meaning greater social support (Sherbourne \& Stewart, 1991) |
Countries
United States
Outcome results
None listed