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Behavioral Intervention

Walk Together for High Blood Pressure

N/A
Recruiting
Led By Sarah Woods, PhD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up protocol completion (approx. 24 months)
Awards & highlights

Study Summary

This trial aims to test a new program called Walk Together, designed to help families manage hypertension together. Researchers want to see if this program can work well and be well-received in primary care settings.

Who is the study for?
This trial is for African American individuals aged 18 to 75 with high blood pressure (two readings of ≥130/≥80 in the past year). They must have a family support person who can join the intervention and both must speak English.Check my eligibility
What is being tested?
The 'Walk Together' program, a family-based hypertension self-management intervention adapted from an existing dyadic approach, is being tested for its practicality and how well it's received when used in primary care settings.See study design
What are the potential side effects?
Since this study focuses on lifestyle interventions rather than medication, side effects are not typical as seen with drugs. However, participants may experience fatigue or muscle soreness due to increased physical activity.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~protocol completion (approx. 24 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and protocol completion (approx. 24 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability of intervention as measured by 8-item Client Satisfaction Questionnaire
Adherence to the intervention as measured by the proportion of dyads successfully completing the four intervention components
Adherence to the intervention as measured by the proportion of participants completing post-treatment assessments
+3 more
Secondary outcome measures
Family relationship quality as measured by the Chronic Illness Resources Survey at Baseline
Family relationship quality as measured by the Chronic Illness Resources Survey following session 3
Family relationship quality as measured by the Chronic Illness Resources Survey following session 4
+7 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Walk TogetherExperimental Treatment1 Intervention
Walk Together involves four sessions delivered in patients' primary care clinic over approximately two months. Sessions are dyadic (i.e., all sessions include the patient and a family support person), last 30-90 minutes, and are delivered by a trained family therapist. The intervention is a culturally-response, family-based intervention that is strengths-based and includes components of integrative behavioral couples therapy and motivational interviewing. The goals of the intervention are to (a) optimize family support and communication, (b) improve hypertension knowledge, (c) enhance self-management goal-setting, and (d) increase shared problem-solving to address self-management adherence barriers. Environmental barriers to adherence are also addressed consistent with standard care.

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Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,048 Previous Clinical Trials
1,054,225 Total Patients Enrolled
National Institute on Minority Health and Health Disparities (NIMHD)NIH
384 Previous Clinical Trials
1,216,432 Total Patients Enrolled
Sarah Woods, PhDPrincipal InvestigatorUT Southwestern Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age range for participants in this study inclusive of individuals under 25 years old?

"Individuals aged 18 to 75 years old are eligible for enrollment in this clinical investigation."

Answered by AI

What is the current number of individuals eligible for enrollment in this clinical research study?

"Indeed, the information available on clinicaltrials.gov highlights that this clinical investigation is actively seeking participants. The trial was initially published on April 5th, 2024 and underwent its last update on the same date. Enrollment of 60 patients across a single site is sought for participation in this study."

Answered by AI

Are new participants still eligible to enroll in this ongoing clinical trial?

"Yes, the details on clinicaltrials.gov specify that this trial is currently open for enrollment. The trial was first listed on April 5th, 2024 and last modified on the same day. It aims to recruit 60 participants at a single site."

Answered by AI

Am I eligible to participate in this clinical investigation?

"The study aims to recruit 60 individuals aged between 18 and 75 who have been diagnosed with hypertension. Eligible participants must identify as Black or African American, be within the specified age range, have recorded two blood pressure readings of ≥130/≥80 in the preceding year, possess a supportive family member willing to engage in the intervention, and be proficient in English."

Answered by AI

What are the anticipated results that researchers hope to achieve through this experimental investigation?

"The primary endpoint in this investigation, to be observed over approximately 11 months, is the adherence to the prescribed intervention. This will be gauged by the percentage of pairs effectively completing all four components of the intervention. Additional aims encompass evaluating family relationship quality post-session 3 and session 4 using the FACES-IV Short Form assessment tool. Family connection strength will also be assessed through scores on a scale ranging from 1 to 5 where higher values suggest improved outcomes. Furthermore, health awareness will be evaluated post-session 4 utilizing the Hypertension (HTN) Evaluation of Lifestyle and Management Knowledge scale; scoring can range from"

Answered by AI
~40 spots leftby Feb 2025