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

Chronic Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03036189
• Other study ID #: MontanaSU
• Secondary ID: U01MD010619
• Status: Completed
• Phase: N/A
• Start date: September 15, 2017
• Est. completion date: January 29, 2020

Study information

• Verified date: June 2023
• Source: Montana State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: January 29, 2020
• Est. primary completion date: January 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease

Intervention

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

Locations

Country	Name	City	State
United States	Messengers for Health	Crow Agency	Montana

Sponsors (4)

Lead Sponsor	Collaborator
Montana State University	National Institute on Minority Health and Health Disparities (NIMHD), National Institutes of Health (NIH), University of Nevada, Las Vegas

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SF-12 - Physical Health	The SF-12 is a set of 12 questions regarding function in physical and mental health domains. We changed question 2 to encapsulate moderate activities more applicable to our study population. Activities deleted were bowling and playing golf and activities added were carrying a small child, walking for exercise, or round dancing/push dancing (Native American traditional dances). Participants responded to questions about their physical and mental health, especially regarding the degree of limitation experienced, using varying response categories (i.e., 3, 5, or 6-point Likert scale, or yes/no format). A Physical Component Summary (PCS) score and a Mental Component Summary (MCS) score were computed and normalized based on an algorithm developed by Farivar, Cunningham, and Hays (2007), which used an oblique factor solution for item weights. PCS and MCS scores range from 0 to 100, with higher scores indicating better physical and mental health functioning, respectively.	Intervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5)
Primary	SF-12 - Mental Health	The SF-12 is a set of 12 questions regarding function in physical and mental health domains. We changed question 2 to encapsulate moderate activities more applicable to our study population. Activities deleted were bowling and playing golf and activities added were carrying a small child, walking for exercise, or round dancing/push dancing (Native American traditional dances). Participants responded to questions about their physical and mental health, especially regarding the degree of limitation experienced, using varying response categories (i.e., 3, 5, or 6-point Likert scale, or yes/no format). A Physical Component Summary (PCS) score and a Mental Component Summary (MCS) score were computed and normalized based on an algorithm developed by Farivar, Cunningham, and Hays (2007), which used an oblique factor solution for item weights. PCS and MCS scores range from 0 to 100, with higher scores indicating better physical and mental health functioning, respectively.	Intervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5)
Secondary	Patient Health Questionnaire-9	The PHQ-9 is a widely used instrument to measure symptoms of depression. This set of 9 questions asked participants to respond to statements pertaining to their mental health in the preceding 2 weeks. The score range for the instrument is 0-27, with higher scores correlating with higher levels of symptoms of depression. Additionally, there is 1 question, not scored, rating difficulty of problems.	Intervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5)
Secondary	PROMIS Satisfaction With Social Roles and Activities	Patient Reported Outcome Measurement Information System (PROMIS) measure. This 8-item form was used to assess the participant's satisfaction with and ability to participant in social roles and activities, using a 5-point Likert scale. NIH PROMIS measures use a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. On the T-score metric a score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population. Higher scores equal more of the concept being measured.	Intervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5)
Secondary	PROMIS Self-Efficacy for Managing Symptoms	Patient Reported Outcome Measurement Information System (PROMIS) measure. This 8 item form was used to assess the participant's confidence in their ability to manage symptoms of chronic illness and prevent them from interfering from activities of daily living, using a 5-point Likert scale. NIH PROMIS measures use a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. On the T-score metric a score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population. Higher scores equal more of the concept being measured.	Intervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5)
Secondary	PROMIS Emotional Support	Patient Reported Outcome Measurement Information System (PROMIS) measure. This 8-item form was used to assess the participant's perception of availability of trusted individuals in their life to provide emotional support, using a 5-point Likert scale. NIH PROMIS measures use a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. On the T-score metric a score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population. Higher scores equal more of the concept being measured.	Intervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5)
Secondary	PROMIS Positive Affect and Well-being	Patient Reported Outcome Measurement Information System (PROMIS) measure. This 8-item form was used to assess the participant's recent sense of well-being and agreement with positive outlook and experience of life, using a 5-point Likert scale. NIH PROMIS measures use a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. On the T-score metric a score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population. Higher scores equal more of the concept being measured.	Intervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5)
Secondary	PROMIS Physical Function	Patient Reported Outcome Measurement Information System (PROMIS) measure. This 8 item form was used to assess the function of upper/lower extremities, core, and ability to perform activities of daily living, using a 5-point Likert scale. NIH PROMIS measures use a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. On the T-score metric a score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population. Higher scores equal more of the concept being measured.	Intervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5)
Secondary	PROMIS Self-efficacy for Managing Emotions	Patient Reported Outcome Measurement Information System (PROMIS) measure. This 8 item form was used to assess the participant's current confidence to manage emotional distress and stressful situations core, using a 5-point Likert scale. NIH PROMIS measures use a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. On the T-score metric a score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population. Higher scores equal more of the concept being measured.	Intervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5)
Secondary	PROMIS Self-efficacy for Managing Social Interactions	Patient Reported Outcome Measurement Information System (PROMIS) measure. This 4 item form was used to assess the participant's current confidence in being able to access support in processing emotions and health problems, and obtain assistance with transportation and problem solving, using a 5-point Likert scale. NIH PROMIS measures use a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. On the T-score metric a score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population. Higher scores equal more of the concept being measured.	Intervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5)
Secondary	Patient Activation Measure	PAM assesses self-management related health knowledge, skills, and confidence. Developed by Insignia Health as a 22-item measure and shortened to 13 questions, with the short form validated to assess patient knowledge, skill and confidence for self-management of health conditions. We used the 13-item measure. Insignia Health's proprietary survey scoring algorithm produces a PAM Score along an empirical, interval-level scale from 0-100 with higher scores indicating higher patient activation.	Intervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5)
Secondary	Modified Timed Up and Go	The TUG test is physical test that assists in screening and measurement of balance deficits in older adults, which correlates with increased fall risk, and has been validated across populations. In this physical test, participants sit in a chair with feet flat on the ground and back against the chair. A timer is started as they leave the chair, and continues as they pace 3 meters, execute a 180 degree turn and just as they touch the chair again, the timer is stopped. Due to an error in communication between a consultant who assisted with this measure and the research team, the distance that individuals walked during this test was modified from 3 m to 10 m, therefore prior validation data may not apply.	Intervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5)
Secondary	Modified Balance Error Scoring System	The original Balance Error Scoring System (BESS) involved firm and padded surface balance testing in 3 positions, to assess static balance and was validated across study populations. The mBESS only utilizes firm surface data and demonstrated better intertester reliability and validity. During this physical test, a staff member counts how many times participants help themselves to regain balance in 20 seconds. The mBESS involved 3 positions, depicted below. Participants stood with hands on hips and eyes closed, balancing for 20 s in 3 standing positions: a double-leg stance, a single-leg stance, and tandem stance. Test observers counted up to 10 errors per stance, including opening eyes, taking hands off hips, stepping, putting a hand out to a chair or wall, or making other large corrections, which led to a stance score ranging from 0 to 10 with a maximum total of 30. Participants who could not complete a position for balance reasons, were given a score of 10.	Intervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5)
Secondary	6-minute Walk	Serves as a corollary for physical function and cardiovascular performance.Participants walked at a comfortable pace for six minutes and their distance was recorded in feet.	Intervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5)