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Hypertension (HTN)NCT07760350

Assessing the Feasibility of the "Heart Care Pairs" Intervention

A study testing Dyadic lifestyle intervention for CVD risk reduction in people with Hypertension (HTN), run by University of Alabama at Birmingham at 1 site in United States.

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Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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Trial 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"). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypertension (HTN)
What is being tested?
Dyadic lifestyle intervention for CVD risk reduction
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
1 siteUnited States
Study dates
1 Nov 2026to 30 Jun 2027
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site
  • Department of Family & Community Medicine; University of Alabama at Birmingham

    Birmingham, Alabama, 35205

Other trials in United States

About this study

Official title: A Mixed Methods Pilot Feasibility Study of a Primary Care-based Dyadic Cardiovascular Risk Reduction Intervention: "Heart Care Pairs"

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.

Read the 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.

Being tested
Dyadic lifestyle intervention for CVD risk reduction
Keywords
hypertension, primary care, integrated behavioral health, dyadic intervention
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dyadic lifestyle intervention for CVD risk reductionBehavioural

    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.

Study groups in NCT07760350
Study groupRoleWhat they receive
InterventionExperimentalDyadic lifestyle intervention for CVD risk reduction "Heart Care Pairs"
Receives: Behavioral: Dyadic lifestyle intervention for CVD risk reduction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Completion of follow-up assessments

    Number of surveys and interviews completed

    Measured: Immediately post-intervention

  2. Time to complete recruitment

    Time from posting recruitment materials to enrollment of 30 dyads

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

  3. Responsiveness to change on survey measures

    Change scores between baseline assessment to follow-up assessment

    Measured: Baseline to immediately post-intervention - approximately 12 weeks

  4. Attendance to intervention sessions

    Number of sessions attended compared to number of sessions missed

    Measured: Baseline to immediately post-intervention - approximately 12 weeks

  5. 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.

    Measured: Immediately post-intervention

Secondary outcomes (14)
  1. Health-related quality of life (HRQoL)

    1-item self-rated health status (Bullinger, 1996; Dumas, et al, 2020)

    Measured: Baseline and immediately post-intervention

  2. Perceived Stress Scale - 10

    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.

    Measured: Baseline and immediately post-intervention

  3. Smoking status

    1-item cigarette smoking status and number cigarettes per day

    Measured: Baseline and immediately post-intervention

  4. Patient Health Questionnaire - 9

    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.

    Measured: Baseline and immediately post-intervention

  5. Generalized anxiety disorder (GAD)-7

    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.

    Measured: Baseline and immediately pot-intervention

  6. Body mass index

    Approximation of body size based on clinic measured height and weight

    Measured: Baseline and immediately post-intervention

  7. Mediterranean Eating Pattern Assessment (MEPA)

    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).

    Measured: Baseline and immediately post-intervention

  8. International physical activity questionnaire short form (IPAQ-SF)

    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.

    Measured: Baseline and immediately post-intervention

  9. Sleep time

    1-item total average sleep time (Lloyd-Jones, et al, 2022)

    Measured: Baseline and immediately post-intervention

  10. Adherence self-report questionnaire (ASRQ)

    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).

    Measured: Baseline and immediately post-intervention

  11. Treatment Self Regulation Questionnaire

    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).

    Measured: Baseline and immediately post-intervention

  12. Important other climate questionnaire

    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.

    Measured: Baseline and immediately post-intervention

  13. Social Support for Diet and Exercise Behaviors

    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.

    Measured: Baseline and immediately post-intervention

  14. Medical Outcomes Study (MOS) Social Support Survey

    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)

    Measured: Baseline and immediately post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2026
  2. Study start1 Nov 2026 (estimated)
  3. Primary completion1 May 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
One armed behavioral pilot feasibility trial
Masking
None (open label)
Enrolment
85 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07760350
Sponsor's protocol ID
IRB-300016958
Other IDs
P50MD017338
Status last verified
Aug 2026
First submitted
24 Jul 2026
Last updated
12 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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