CClinicalTrials.gg
CompletedNCT02830945FITSMIUpdated Oct 12, 2018

Innovative Multigenerational Household Intervention to Reduce Stroke and CVD

An interventional study of Motivational Interviewing Intervention Arm and Control Brochure Arm in Stroke and Cardiovascular Disease, sponsored by Washington State University. Completed at 4 sites in United States. Open to participants aged 11 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-12.

Sponsored by Washington State University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Jul 2015, registered May 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
458
Allocation
Randomized
Ages
11 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Stroke
  • Cardiovascular Disease
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 458 is above the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Washington State University is the lead sponsor of 82 studies on the registry; 16 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
11 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Under the age of 11
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
458 participants (actual)

Study arms

  • Other
    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

Interventions

  • BehavioralMotivational Interviewing Intervention Arm
  • OtherControl Brochure Arm
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What researchers measure

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.

    Time frame: 1 year

07

Study locations

4 sites
  • 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
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 12, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02830945
Lead sponsor
Washington State University
Responsible party
Dedra Buchwald (Principal Investigator, Washington State University) — Principal investigator
First posted
Jul 13, 2016
Start date
Jul 1, 2015
Primary completion
May 31, 2018
Completion
May 31, 2018
Last update
Oct 12, 2018

Study contacts

Lonnie Nelson, PhD
principal investigator · WSU-IREACH

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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