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

NCT ID: NCT03036189

Last Updated: 2023-06-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

211 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-15

Study Completion Date

2020-01-29

Brief Summary

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

Detailed Description

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Conditions

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Chronic Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

delayed control group design
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

baa nnilah

Intervention Type BEHAVIORAL

7 meetings in the community led by a trained community facilitator

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.

Group Type EXPERIMENTAL

baa nnilah

Intervention Type BEHAVIORAL

7 meetings in the community led by a trained community facilitator

Interventions

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baa nnilah

7 meetings in the community led by a trained community facilitator

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

University of Nevada, Las Vegas

OTHER

Sponsor Role collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

Montana State University

OTHER

Sponsor Role lead

Responsible Party

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Suzanne Held

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Suzanne Held, PhD

Role: PRINCIPAL_INVESTIGATOR

Montana State University

Locations

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Messengers for Health

Crow Agency, Montana, United States

Site Status

Countries

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United States

References

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Farivar SS, Cunningham WE, Hays RD. Correlated physical and mental health summary scores for the SF-36 and SF-12 Health Survey, V.I. Health Qual Life Outcomes. 2007 Sep 7;5:54. doi: 10.1186/1477-7525-5-54.

Reference Type BACKGROUND
PMID: 17825096 (View on PubMed)

Hallett J, Feng D, McCormick AKHG, Allen S, Inouye J, Schure M, Holder S, Medicine LO, Held S. Improving Chronic Illness Self-Management with the Apsaalooke Nation: The Baa nnilah Project, a cluster randomized trial protocol. Contemp Clin Trials. 2022 Aug;119:106835. doi: 10.1016/j.cct.2022.106835. Epub 2022 Jun 18.

Reference Type DERIVED
PMID: 35724843 (View on PubMed)

Allen S, Held S, Milne-Price S, McCormick A, Feng D, Inouye J, Schure M, Castille D, Howe RB, Pitts M, Keene S, Belone L, Wallerstein N. Community sharing: Contextualizing Western research notions of contamination within an Indigenous research paradigm. Am J Community Psychol. 2022 Mar;69(1-2):145-156. doi: 10.1002/ajcp.12552. Epub 2021 Sep 17.

Reference Type DERIVED
PMID: 34534371 (View on PubMed)

Rink E, Knight K, Ellis C, McCormick A, FireMoon P, Held S, Webber E, Adams A. Using Community-Based Participatory Research to Design, Conduct, and Evaluate Randomized Controlled Trials with American Indian Communities. Prev Chronic Dis. 2020 Nov 12;17:E143. doi: 10.5888/pcd17.200099.

Reference Type DERIVED
PMID: 33180688 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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U01MD010619

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MontanaSU

Identifier Type: -

Identifier Source: org_study_id

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