Innovative Multigenerational Household Intervention to Reduce Stroke and CVD

Not Applicable

Completed

• Conditions: Cardiovascular Disease; Stroke

• Registration Number: NCT02830945
• Lead Sponsor: Washington State University

Brief Summary

American Indians (AI's) are experiencing an epidemic of stroke morbidity and mortality, with higher prevalence and incidence, younger age at onset, and poorer survival than other racial and ethnic groups. With a stroke incidence more than twice that of the general U.S. population, stroke in AI's is a public health problem of staggering scope. AI's also have disproportionate burdens of many risk factors for stroke, including hypertension, smoking, obesity, and diabetes. However, no rigorous, population-based studies of stroke prevention have included AI's. The investigators at WSU, and community partners, have designed the "Family Intervention in the Spirit of Motivational Interviewing" (FITSMI), a program delivered at the household level to encourage lifestyle changes that transform the home environment and reduce stroke risk for all residents. FITSMI uses a "talking circle" format in which facilitators guide participants to identify goals for change and create a tailored plan for sustainable implementation that may target smoking, exercise, diet, or medication adherence. FITSMI requires just 2 sessions (baseline and 1 month post-baseline), with text messaging used to boost long-term adherence. In a group-randomized trial design, the investigators will recruit 360 households where Strong Heart Family Study members aged 45 and older reside. The investigators will assign half to FITSMI and half to a control condition that receives educational brochures.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-01
• Study First Submitted: 2016-05-24
• Study First Submitted QC: 2016-07-08
• Study First Posted: 2016-07-13
• Primary Completion: 2018-05-31
• Study Completion: 2018-05-31
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-10
• Last Update Posted: 2018-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 458

Inclusion Criteria

• Household must include one member over the age of 45 (index participant)

Exclusion Criteria

• Under the age of 11

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Stroke Risk Classification	1 year	Investigators will use the Stroke Risk Scorecard, developed by the National Stroke Association to classify the stroke risk of participants. The factors used to classify stroke risk will be collected using a questionnaire to assess the prevalence of high blood pressure, atrial fibrillation, smoking, high cholesterol, physical activity, weight, and family history of stroke.

Trial Locations

Locations (4)

Medstar Health Research; 🇺🇸 Phoenix, Arizona, United States

Oklahoma University Health Science Center; 🇺🇸 Oklahoma City, Oklahoma, United States

Missouri Breaks Industries Research Inc.; 🇺🇸 Eagle Butte, South Dakota, United States

Washington State University; 🇺🇸 Seattle, Washington, United States