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Improving Chronic Illness Management With the Apsaalooke Nation: The Baa Nnilah Project

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: NCT03036189
Recruitment Status : Completed
First Posted : January 30, 2017
Last Update Posted : March 23, 2020
Sponsor:
Collaborators:
National Institutes of Health (NIH)
University of Nevada, Las Vegas
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Suzanne Held, Montana State University

Tracking Information
First Submitted Date  ICMJE January 24, 2017
First Posted Date  ICMJE January 30, 2017
Last Update Posted Date March 23, 2020
Actual Study Start Date  ICMJE September 15, 2017
Actual Primary Completion Date January 29, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2017)
Change in SF-12 [ Time Frame: before intervention and 6 months and 12 months after ]
quality of life measure
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Improving Chronic Illness Management With the Apsaalooke Nation: The Baa Nnilah Project
Official Title  ICMJE Improving Chronic Illness Management With the Apsaalooke Nation: The Baa Nnilah Project
Brief Summary This is a group randomized trial of an intervention to improve chronic illness self-management.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
delayed control group design
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Disease
Intervention  ICMJE Behavioral: baa nnilah
7 meetings in the community led by a trained community facilitator
Study Arms  ICMJE
  • Experimental: Intervention arm
    There are no devices or drugs used in this trial. The treatment is the same for the intervention arm and the wait-list control arm. The treatment is group trial of 7 meetings designed to improve chronic illness self-management. The name of the treatment is baa nnilah.
    Intervention: Behavioral: baa nnilah
  • Experimental: Wait-list control arm
    There are no devices or drugs used in this trial. The treatment is the same for the intervention arm and the wait-list control arm. The treatment is group trial of 7 meetings designed to improve chronic illness self-management. The name of the treatment is baa nnilah.
    Intervention: Behavioral: baa nnilah
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 20, 2020)
223
Original Estimated Enrollment  ICMJE
 (submitted: January 26, 2017)
200
Actual Study Completion Date  ICMJE January 29, 2020
Actual Primary Completion Date January 29, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ≥ 25 years
  • AI
  • diagnosed with diabetes
  • hypertension
  • osteoporosis
  • liver disease
  • chronic lung disease (asthma, chronic bronchitis or emphysema)
  • heart disease (coronary artery disease or congestive heart failure)
  • stroke (completed cerebrovascular accident with neurologic handicap and normal mentation)
  • chronic arthritis

Exclusion Criteria:

  • major medical illness that precludes their attendance at 7 meetings
  • <25 years of age
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03036189
Other Study ID Numbers  ICMJE MontanaSU
U01MD010619 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Suzanne Held, Montana State University
Study Sponsor  ICMJE Montana State University
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • University of Nevada, Las Vegas
  • National Institute on Minority Health and Health Disparities (NIMHD)
Investigators  ICMJE
Principal Investigator: Suzanne Held, PhD Montana State University
PRS Account Montana State University
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP