Innovative Multigenerational Household Intervention to Reduce Stroke and CVD (FITSMI)

Washington State University

Status: Completed

Conditions: Stroke; Cardiovascular Disease

Treatments: Other: Control Brochure Arm; Behavioral: Motivational Interviewing Intervention Arm

Study type: Interventional

Funder types: Other

Identifiers

NCT02830945

1R01HL122148

Details and patient eligibility

About

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.

Enrollment: 458 patients

Sex: All

Ages: 11+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Under the age of 11

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

458 participants in 2 patient groups

Control Brochure Arm

Other group

Description:

Control Arm households receive a culturally tailored Stroke and CVD brochure for prevention.

Treatment:

Other: Control Brochure Arm

Motivational Interviewing Intervention Arm

Experimental group

Description:

The MI intervention households receive three aspects of the intervention: digital stories, motivational interviewing talking circle and the option to receive text messages to adhere to the action plan.

Treatment:

Behavioral: Motivational Interviewing Intervention Arm