Assessing the Feasibility of the "Heart Care Pairs" Intervention
ConditionHypertension (HTN)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alabama at Birmingham
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
untreated serious mental illness or cognitive decline that would limit ability to provide informed consent
Trial design
Design model
Single group
Treatments tested in this trial
Dyadic lifestyle intervention for CVD risk reduction
BehavioralThis 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.
Treatment groups
85 Participants
are divided into 1 treatment groupGroup A: InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Completion of follow-up assessments
Number of surveys and interviews completed
Time frame
Immediately post-intervention2
Time to complete recruitment
Time from posting recruitment materials to enrollment of 30 dyads
Time frame
From study start to end of recruitment, an average of 6 months3
Responsiveness to change on survey measures
Change scores between baseline assessment to follow-up assessment
Time frame
Baseline to immediately post-intervention - approximately 12 weeks4
Attendance to intervention sessions
Number of sessions attended compared to number of sessions missed
Time frame
Baseline to immediately post-intervention - approximately 12 weeksSecondary outcomes
1
Health-related quality of life (HRQoL)
1-item self-rated health status (Bullinger, 1996; Dumas, et al, 2020)
Time frame
Baseline and immediately post-intervention2
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.
Time frame
Baseline and immediately post-intervention3
Smoking status
1-item cigarette smoking status and number cigarettes per day
Time frame
Baseline and immediately post-intervention4
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.
Time frame
Baseline and immediately post-interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Alabama at Birmingham
Lead sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: