Innovative Multigenerational Household Intervention to Reduce Stroke and CVD

Stroke Clinical Trial

— FITSMI  

Official title:

Innovative Multigenerational Household Intervention to Reduce Stroke and CVD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02830945
• Other study ID #: 1R01HL122148
• Status: Completed
• Phase: N/A
• Start date: July 1, 2015
• Est. completion date: May 31, 2018

Study information

• Verified date: October 2018
• Source: Washington State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 458
• Est. completion date: May 31, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Under the age of 11

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Stroke

Intervention

Behavioral:
• Motivational Interviewing Intervention Arm

Other:
• Control Brochure Arm

Locations

Country	Name	City	State
United States	Missouri Breaks Industries Research Inc.	Eagle Butte	South Dakota
United States	Oklahoma University Health Science Center	Oklahoma City	Oklahoma
United States	Medstar Health Research	Phoenix	Arizona
United States	Washington State University	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Washington State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stroke Risk Classification	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.	1 year