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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 : Active, not recruiting
First Posted : January 30, 2017
Last Update Posted : March 22, 2018
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

Brief Summary:
This is a group randomized trial of an intervention to improve chronic illness self-management.

Condition or disease Intervention/treatment Phase
Chronic Disease Behavioral: baa nnilah Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: delayed control group design
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Chronic Illness Management With the Apsaalooke Nation: The Baa Nnilah Project
Actual Study Start Date : September 15, 2017
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Behavioral: baa nnilah
7 meetings in the community led by a trained community facilitator

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.
Behavioral: baa nnilah
7 meetings in the community led by a trained community facilitator




Primary Outcome Measures :
  1. Change in SF-12 [ Time Frame: before intervention and 6 months and 12 months after ]
    quality of life measure



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03036189


Locations
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United States, Montana
Messengers for Health
Crow Agency, Montana, United States, 59022
Sponsors and Collaborators
Montana State University
National Institutes of Health (NIH)
University of Nevada, Las Vegas
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
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Principal Investigator: Suzanne Held, PhD Montana State University
  Study Documents (Full-Text)

Documents provided by Suzanne Held, Montana State University:
Informed Consent Form  [PDF] August 20, 2017


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Responsible Party: Suzanne Held, Professor, Montana State University
ClinicalTrials.gov Identifier: NCT03036189     History of Changes
Other Study ID Numbers: MontanaSU
U01MD010619 ( U.S. NIH Grant/Contract )
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Chronic Disease
Disease Attributes
Pathologic Processes