Assessing the Feasibility of the "Heart Care Pairs" Intervention

NCT07760350 | Not Yet Recruiting

• 2 other identifiers: IRB-300016958P50MD017338
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension (HTN)

Keywords

hypertension; primary care; integrated behavioral health; dyadic intervention

Outcome Measures

Primary Outcomes (5)

• Completion of follow-up assessments

  Number of surveys and interviews completed

  Immediately post-intervention

• Time to complete recruitment

  Time from posting recruitment materials to enrollment of 30 dyads

  From study start to end of recruitment, an average of 6 months

• Responsiveness to change on survey measures

  Change scores between baseline assessment to follow-up assessment

  Baseline to immediately post-intervention - approximately 12 weeks

• Attendance to intervention sessions

  Number of sessions attended compared to number of sessions missed

  Baseline to immediately post-intervention - approximately 12 weeks

• Treatment Satisfaction Questionnaire

  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.

  Immediately post-intervention

Secondary Outcomes (14)

• 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

Study Arms (1)

Intervention

EXPERIMENTAL

Dyadic lifestyle intervention for CVD risk reduction "Heart Care Pairs"

Behavioral: Dyadic lifestyle intervention for CVD risk reduction

Interventions

Dyadic lifestyle intervention for CVD risk reduction BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• untreated serious mental illness or cognitive decline that would limit ability to provide informed consent

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Department of Family & Community Medicine; University of Alabama at Birmingham

Birmingham, Alabama, 35205, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: One armed behavioral pilot feasibility trial

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: August 12, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 12, 2026

Record last verified: 2026-08

Locations

US (1)