Innovative Multigenerational Household Intervention to Reduce Stroke and CVD (FITSMI)
Primary Purpose
Stroke, Cardiovascular Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational Interviewing Intervention Arm
Control Brochure Arm
Sponsored by

About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
Inclusion Criteria:
- Household must include one member over the age of 45 (index participant)
Exclusion Criteria:
- Under the age of 11
Sites / Locations
- Medstar Health Research
- Oklahoma University Health Science Center
- Missouri Breaks Industries Research Inc.
- Washington State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Control Brochure Arm
Motivational Interviewing Intervention Arm
Arm Description
Control Arm households receive a culturally tailored Stroke and CVD brochure for prevention.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02830945
First Posted
May 24, 2016
Last Updated
October 10, 2018
Sponsor
Washington State University
1. Study Identification
Unique Protocol Identification Number
NCT02830945
Brief Title
Innovative Multigenerational Household Intervention to Reduce Stroke and CVD
Acronym
FITSMI
Official Title
Innovative Multigenerational Household Intervention to Reduce Stroke and CVD
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
July 1, 2015 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
May 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington State University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cardiovascular Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Clinical Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
458 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Brochure Arm
Arm Type
Other
Arm Description
Control Arm households receive a culturally tailored Stroke and CVD brochure for prevention.
Arm Title
Motivational Interviewing Intervention Arm
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing Intervention Arm
Intervention Type
Other
Intervention Name(s)
Control Brochure Arm
Primary Outcome Measure Information:
Title
Stroke Risk Classification
Description
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.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Household must include one member over the age of 45 (index participant)
Exclusion Criteria:
Under the age of 11
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lonnie Nelson, PhD
Organizational Affiliation
WSU-IREACH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medstar Health Research
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Oklahoma University Health Science Center
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Missouri Breaks Industries Research Inc.
City
Eagle Butte
State/Province
South Dakota
ZIP/Postal Code
57625
Country
United States
Facility Name
Washington State University
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Innovative Multigenerational Household Intervention to Reduce Stroke and CVD
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