A Mixed Methods Pilot Feasibility Study of a Primary Care-based Dyadic Cardiovascular Risk Reduction Intervention: "Heart Care Pairs"
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 85
- Locations
- 1
- Primary Endpoint
- Completion of follow-up assessments
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Intervention
Dyadic lifestyle intervention for CVD risk reduction "Heart Care Pairs"
Intervention: Dyadic lifestyle intervention for CVD risk reduction (Behavioral)
Outcomes
Primary Outcomes
Completion of follow-up assessments
Time Frame: Immediately post-intervention
Number of surveys and interviews completed
Time to complete recruitment
Time Frame: 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
Time Frame: Baseline to immediately post-intervention - approximately 12 weeks
Change scores between baseline assessment to follow-up assessment
Attendance to intervention sessions
Time Frame: Baseline to immediately post-intervention - approximately 12 weeks
Number of sessions attended compared to number of sessions missed
Treatment Satisfaction Questionnaire
Time Frame: 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 Outcomes
- Health-related quality of life (HRQoL)(Baseline and immediately post-intervention)
- Perceived Stress Scale - 10(Baseline and immediately post-intervention)
- Smoking status(Baseline and immediately post-intervention)
- Patient Health Questionnaire - 9(Baseline and immediately post-intervention)
- Generalized anxiety disorder (GAD)-7(Baseline and immediately pot-intervention)
- Body mass index(Baseline and immediately post-intervention)
- Mediterranean Eating Pattern Assessment (MEPA)(Baseline and immediately post-intervention)
- International physical activity questionnaire short form (IPAQ-SF)(Baseline and immediately post-intervention)
- Sleep time(Baseline and immediately post-intervention)
- Adherence self-report questionnaire (ASRQ)(Baseline and immediately post-intervention)
- Treatment Self Regulation Questionnaire(Baseline and immediately post-intervention)
- Important other climate questionnaire(Baseline and immediately post-intervention)
- Social Support for Diet and Exercise Behaviors(Baseline and immediately post-intervention)
- Medical Outcomes Study (MOS) Social Support Survey(Baseline and immediately post-intervention)
Investigators
Kaylee Crockett
Assistant Professor
University of Alabama at Birmingham