Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02830945
Recruitment Status : Completed
First Posted : July 13, 2016
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Dedra Buchwald, Washington State University

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.

Condition or disease Intervention/treatment Phase
Stroke Cardiovascular Disease Behavioral: Motivational Interviewing Intervention Arm Other: Control Brochure Arm Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 458 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Clinical Trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Innovative Multigenerational Household Intervention to Reduce Stroke and CVD
Actual Study Start Date : July 1, 2015
Actual Primary Completion Date : May 31, 2018
Actual Study Completion Date : May 31, 2018

Arm Intervention/treatment
Control Brochure Arm
Control Arm households receive a culturally tailored Stroke and CVD brochure for prevention.
Other: Control Brochure Arm
Experimental: Motivational Interviewing Intervention Arm
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.
Behavioral: Motivational Interviewing Intervention Arm



Primary Outcome Measures :
  1. Stroke Risk Classification [ Time Frame: 1 year ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   11 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Under the age of 11

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02830945


Locations
Layout table for location information
United States, Arizona
Medstar Health Research
Phoenix, Arizona, United States
United States, Oklahoma
Oklahoma University Health Science Center
Oklahoma City, Oklahoma, United States
United States, South Dakota
Missouri Breaks Industries Research Inc.
Eagle Butte, South Dakota, United States, 57625
United States, Washington
Washington State University
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Washington State University
Investigators
Layout table for investigator information
Principal Investigator: Lonnie Nelson, PhD WSU-IREACH

Layout table for additonal information
Responsible Party: Dedra Buchwald, Principal Investigator, Washington State University
ClinicalTrials.gov Identifier: NCT02830945     History of Changes
Other Study ID Numbers: 1R01HL122148 ( U.S. NIH Grant/Contract )
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases