Innovative Multigenerational Household Intervention to Reduce Stroke and CVD
FITSMI
1 other identifier
interventional
458
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Jul 2015
Typical duration for not_applicable stroke
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 24, 2016
CompletedFirst Posted
Study publicly available on registry
July 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2018
CompletedOctober 12, 2018
October 1, 2018
2.9 years
May 24, 2016
October 10, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Control Brochure Arm
OTHERControl Arm households receive a culturally tailored Stroke and CVD brochure for prevention.
Motivational Interviewing Intervention Arm
EXPERIMENTALThe 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.
Interventions
Eligibility Criteria
You may qualify if:
- Household must include one member over the age of 45 (index participant)
You may not qualify if:
- Under the age of 11
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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, 57625, United States
Washington State University
Seattle, Washington, 98101, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lonnie Nelson, PhD
WSU-IREACH
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 24, 2016
First Posted
July 13, 2016
Study Start
July 1, 2015
Primary Completion
May 31, 2018
Study Completion
May 31, 2018
Last Updated
October 12, 2018
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will not share