Innovative Multigenerational Household Intervention to Reduce Stroke and CVD
FITSMI
FITSMI
Sponsor study identifier
NIH
interventional
458
1 country
4
Study Start
July 1, 2015
Actual (reported)Primary Completion
May 31, 2018
Actual (reported)Study Completion
May 31, 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 31, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 1, 2015
Actual (reported)May 24, 2016
Actual (reported)July 13, 2016
Actual (reported)May 31, 2018
Actual (reported)May 31, 2018
Actual (reported)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
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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
Lonnie Nelson, PhD
WSU-IREACH
458 participants (actual enrollment reported by the registry).
First Submitted
May 24, 2016
First Posted
July 13, 2016
Study Start
July 1, 2015
Actual (reported)Poststroke Fatigue - Developing and Testing a Program to Reduce and Cope With Fatigue
Contact the study team to confirm eligibility.
Primary Completion
May 31, 2018
Actual (reported)Study Completion
May 31, 2018
Actual (reported)Last Updated
October 12, 2018
Record last verified: 2018-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: