NCT02830945

Innovative Multigenerational Household Intervention to Reduce Stroke and CVD

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 458 (actual)
• Sponsor: Washington State University · Academic / Other
• Sex: All
• Age: 11 Years
• Healthy volunteers: Accepted

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.

Conditions

• Stroke
• Cardiovascular Disease

Interventions

Type	Name	Description
BEHAVIORAL	Motivational Interviewing Intervention Arm
OTHER	Control Brochure Arm

Timeline

• Start date: 2015-07-01
• Primary completion: 2018-05-31
• Completion: 2018-05-31
• First posted: 2016-07-13
• Last updated: 2018-10-12

Locations

4 sites across 1 country: United States