Trial Outcomes & Findings for Improving Chronic Illness Management With the Apsaalooke Nation: The Baa Nnilah Project (NCT NCT03036189)
NCT ID: NCT03036189
Last Updated: 2023-06-28
Results Overview
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.
COMPLETED
NA
211 participants
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)
2023-06-28
Participant Flow
Participant milestones
| Measure |
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.
baa nnilah: 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.
baa nnilah: 7 meetings in the community led by a trained community facilitator
|
|---|---|---|
|
Overall Study
STARTED
|
104
|
107
|
|
Overall Study
COMPLETED
|
69
|
74
|
|
Overall Study
NOT COMPLETED
|
35
|
33
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
missing data
Baseline characteristics by cohort
| Measure |
Intervention Arm
n=104 Participants
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.
baa nnilah: 7 meetings in the community led by a trained community facilitator
|
Wait-list Control Arm
n=107 Participants
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.
baa nnilah: 7 meetings in the community led by a trained community facilitator
|
Total
n=211 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.71 years
STANDARD_DEVIATION 13.47 • n=101 Participants • missing data
|
52.46 years
STANDARD_DEVIATION 14.36 • n=104 Participants • missing data
|
52.09 years
STANDARD_DEVIATION 13.47 • n=205 Participants • missing data
|
|
Sex: Female, Male
Female
|
69 Participants
n=104 Participants
|
83 Participants
n=107 Participants
|
152 Participants
n=211 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=104 Participants
|
24 Participants
n=107 Participants
|
59 Participants
n=211 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
104 Participants
n=104 Participants
|
107 Participants
n=107 Participants
|
211 Participants
n=211 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=104 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=211 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=104 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=211 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=104 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=211 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=104 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=211 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=104 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=211 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=104 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=211 Participants
|
PRIMARY outcome
Timeframe: 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)Population: The number of valid data points varied across individuals, as well as by time and by variable within each individual, because participants could 1) miss a data collection but complete subsequent data collection(s) and/or 2) choose not to complete a physical test or a survey question.
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.
Outcome measures
| Measure |
Intervention Arm
n=93 Participants
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.
baa nnilah: 7 meetings in the community led by a trained community facilitator
|
Wait-list Control Arm
n=94 Participants
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.
baa nnilah: 7 meetings in the community led by a trained community facilitator
|
|---|---|---|
|
SF-12 - Physical Health
T1
|
43.85 score on a scale
Standard Deviation 11.18
|
43.64 score on a scale
Standard Deviation 9.97
|
|
SF-12 - Physical Health
T2
|
45.65 score on a scale
Standard Deviation 10.86
|
45.18 score on a scale
Standard Deviation 9.42
|
|
SF-12 - Physical Health
T3
|
45.56 score on a scale
Standard Deviation 11.04
|
44.50 score on a scale
Standard Deviation 10.03
|
|
SF-12 - Physical Health
T4
|
45.33 score on a scale
Standard Deviation 10.53
|
45.26 score on a scale
Standard Deviation 9.63
|
|
SF-12 - Physical Health
T5
|
—
|
47.13 score on a scale
Standard Deviation 9.51
|
PRIMARY outcome
Timeframe: 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)Population: The number of valid data points varied across individuals, as well as by time and by variable within each individual, because participants could 1) miss a data collection but complete subsequent data collection(s) and/or 2) choose not to complete a physical test or a survey question.
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.
Outcome measures
| Measure |
Intervention Arm
n=93 Participants
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.
baa nnilah: 7 meetings in the community led by a trained community facilitator
|
Wait-list Control Arm
n=94 Participants
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.
baa nnilah: 7 meetings in the community led by a trained community facilitator
|
|---|---|---|
|
SF-12 - Mental Health
T1
|
43.85 units on a scale
Standard Deviation 11.18
|
43.64 units on a scale
Standard Deviation 9.97
|
|
SF-12 - Mental Health
T2
|
45.65 units on a scale
Standard Deviation 10.86
|
45.18 units on a scale
Standard Deviation 9.44
|
|
SF-12 - Mental Health
T3
|
45.56 units on a scale
Standard Deviation 11.04
|
44.50 units on a scale
Standard Deviation 10.03
|
|
SF-12 - Mental Health
T4
|
45.33 units on a scale
Standard Deviation 10.52
|
45.26 units on a scale
Standard Deviation 9.63
|
|
SF-12 - Mental Health
T5
|
—
|
49.30 units on a scale
Standard Deviation 10.10
|
SECONDARY outcome
Timeframe: 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)Population: The number of valid data points varied across individuals, as well as by time and by variable within each individual, because participants could 1) miss a data collection but complete subsequent data collection(s) and/or 2) choose not to complete a physical test or a survey question.
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.
Outcome measures
| Measure |
Intervention Arm
n=103 Participants
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.
baa nnilah: 7 meetings in the community led by a trained community facilitator
|
Wait-list Control Arm
n=107 Participants
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.
baa nnilah: 7 meetings in the community led by a trained community facilitator
|
|---|---|---|
|
Patient Health Questionnaire-9
T1
|
5.29 units on a scale
Standard Deviation 5.88
|
7.22 units on a scale
Standard Deviation 7.47
|
|
Patient Health Questionnaire-9
T2
|
5.43 units on a scale
Standard Deviation 6.03
|
6.24 units on a scale
Standard Deviation 6.20
|
|
Patient Health Questionnaire-9
T3
|
4.30 units on a scale
Standard Deviation 4.87
|
5.50 units on a scale
Standard Deviation 5.98
|
|
Patient Health Questionnaire-9
T4
|
5.38 units on a scale
Standard Deviation 6.06
|
4.92 units on a scale
Standard Deviation 5.70
|
|
Patient Health Questionnaire-9
T5
|
—
|
4.45 units on a scale
Standard Deviation 5.45
|
SECONDARY outcome
Timeframe: 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)Population: The number of valid data points varied across individuals, as well as by time and by variable within each individual, because participants could 1) miss a data collection but complete subsequent data collection(s) and/or 2) choose not to complete a physical test or a survey question.
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.
Outcome measures
| Measure |
Intervention Arm
n=102 Participants
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.
baa nnilah: 7 meetings in the community led by a trained community facilitator
|
Wait-list Control Arm
n=106 Participants
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.
baa nnilah: 7 meetings in the community led by a trained community facilitator
|
|---|---|---|
|
PROMIS Satisfaction With Social Roles and Activities
T1
|
53.62 units on a scale
Standard Deviation 10.11
|
54.03 units on a scale
Standard Deviation 9.62
|
|
PROMIS Satisfaction With Social Roles and Activities
T2
|
53.26 units on a scale
Standard Deviation 10.76
|
53.65 units on a scale
Standard Deviation 9.64
|
|
PROMIS Satisfaction With Social Roles and Activities
T3
|
53.61 units on a scale
Standard Deviation 10.01
|
54.05 units on a scale
Standard Deviation 9.27
|
|
PROMIS Satisfaction With Social Roles and Activities
T4
|
53.00 units on a scale
Standard Deviation 9.89
|
55.10 units on a scale
Standard Deviation 9.36
|
|
PROMIS Satisfaction With Social Roles and Activities
T5
|
—
|
55.00 units on a scale
Standard Deviation 9.17
|
SECONDARY outcome
Timeframe: 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)Population: The number of valid data points varied across individuals, as well as by time and by variable within each individual, because participants could 1) miss a data collection but complete subsequent data collection(s) and/or 2) choose not to complete a physical test or a survey question.
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.
Outcome measures
| Measure |
Intervention Arm
n=103 Participants
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.
baa nnilah: 7 meetings in the community led by a trained community facilitator
|
Wait-list Control Arm
n=106 Participants
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.
baa nnilah: 7 meetings in the community led by a trained community facilitator
|
|---|---|---|
|
PROMIS Self-Efficacy for Managing Symptoms
T1
|
49.33 units on a scale
Standard Deviation 9.64
|
48.15 units on a scale
Standard Deviation 9.37
|
|
PROMIS Self-Efficacy for Managing Symptoms
T2
|
48.48 units on a scale
Standard Deviation 9.36
|
47.12 units on a scale
Standard Deviation 8.34
|
|
PROMIS Self-Efficacy for Managing Symptoms
T3
|
50.45 units on a scale
Standard Deviation 8.96
|
48.93 units on a scale
Standard Deviation 9.67
|
|
PROMIS Self-Efficacy for Managing Symptoms
T4
|
49.55 units on a scale
Standard Deviation 9.86
|
50.61 units on a scale
Standard Deviation 9.90
|
|
PROMIS Self-Efficacy for Managing Symptoms
T5
|
—
|
50.63 units on a scale
Standard Deviation 9.94
|
SECONDARY outcome
Timeframe: 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)Population: The number of valid data points varied across individuals, as well as by time and by variable within each individual, because participants could 1) miss a data collection but complete subsequent data collection(s) and/or 2) choose not to complete a physical test or a survey question.
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.
Outcome measures
| Measure |
Intervention Arm
n=103 Participants
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.
baa nnilah: 7 meetings in the community led by a trained community facilitator
|
Wait-list Control Arm
n=107 Participants
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.
baa nnilah: 7 meetings in the community led by a trained community facilitator
|
|---|---|---|
|
PROMIS Emotional Support
T1
|
52.71 units on a scale
Standard Deviation 9.65
|
51.65 units on a scale
Standard Deviation 11.09
|
|
PROMIS Emotional Support
T2
|
53.31 units on a scale
Standard Deviation 8.90
|
53.36 units on a scale
Standard Deviation 9.28
|
|
PROMIS Emotional Support
T3
|
53.29 units on a scale
Standard Deviation 9.09
|
52.32 units on a scale
Standard Deviation 10.03
|
|
PROMIS Emotional Support
T4
|
53.16 units on a scale
Standard Deviation 8.62
|
54.96 units on a scale
Standard Deviation 8.35
|
|
PROMIS Emotional Support
T5
|
—
|
53.35 units on a scale
Standard Deviation 9.05
|
SECONDARY outcome
Timeframe: 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)Population: The number of valid data points varied across individuals, as well as by time and by variable within each individual, because participants could 1) miss a data collection but complete subsequent data collection(s) and/or 2) choose not to complete a physical test or a survey question.
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.
Outcome measures
| Measure |
Intervention Arm
n=102 Participants
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.
baa nnilah: 7 meetings in the community led by a trained community facilitator
|
Wait-list Control Arm
n=106 Participants
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.
baa nnilah: 7 meetings in the community led by a trained community facilitator
|
|---|---|---|
|
PROMIS Positive Affect and Well-being
T1
|
56.32 units on a scale
Standard Deviation 7.92
|
56.37 units on a scale
Standard Deviation 8.98
|
|
PROMIS Positive Affect and Well-being
T2
|
57.84 units on a scale
Standard Deviation 8.18
|
57.37 units on a scale
Standard Deviation 8.42
|
|
PROMIS Positive Affect and Well-being
T3
|
57.64 units on a scale
Standard Deviation 7.65
|
57.15 units on a scale
Standard Deviation 8.37
|
|
PROMIS Positive Affect and Well-being
T4
|
58.50 units on a scale
Standard Deviation 8.34
|
58.64 units on a scale
Standard Deviation 7.54
|
|
PROMIS Positive Affect and Well-being
T5
|
—
|
58.35 units on a scale
Standard Deviation 6.93
|
SECONDARY outcome
Timeframe: 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)Population: The number of valid data points varied across individuals, as well as by time and by variable within each individual, because participants could 1) miss a data collection but complete subsequent data collection(s) and/or 2) choose not to complete a physical test or a survey question.
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.
Outcome measures
| Measure |
Intervention Arm
n=103 Participants
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.
baa nnilah: 7 meetings in the community led by a trained community facilitator
|
Wait-list Control Arm
n=107 Participants
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.
baa nnilah: 7 meetings in the community led by a trained community facilitator
|
|---|---|---|
|
PROMIS Physical Function
T1
|
44.94 units on a scale
Standard Deviation 8.81
|
45.49 units on a scale
Standard Deviation 8.74
|
|
PROMIS Physical Function
T2
|
45.83 units on a scale
Standard Deviation 9.08
|
45.55 units on a scale
Standard Deviation 8.52
|
|
PROMIS Physical Function
T3
|
45.00 units on a scale
Standard Deviation 10.17
|
45.23 units on a scale
Standard Deviation 9.28
|
|
PROMIS Physical Function
T4
|
45.91 units on a scale
Standard Deviation 10.48
|
44.81 units on a scale
Standard Deviation 9.86
|
|
PROMIS Physical Function
T5
|
—
|
45.82 units on a scale
Standard Deviation 8.88
|
SECONDARY outcome
Timeframe: 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)Population: The number of valid data points varied across individuals, as well as by time and by variable within each individual, because participants could 1) miss a data collection but complete subsequent data collection(s) and/or 2) choose not to complete a physical test or a survey question.
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.
Outcome measures
| Measure |
Intervention Arm
n=103 Participants
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.
baa nnilah: 7 meetings in the community led by a trained community facilitator
|
Wait-list Control Arm
n=107 Participants
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.
baa nnilah: 7 meetings in the community led by a trained community facilitator
|
|---|---|---|
|
PROMIS Self-efficacy for Managing Emotions
T1
|
48.18 units on a scale
Standard Deviation 9.13
|
48.28 units on a scale
Standard Deviation 9.84
|
|
PROMIS Self-efficacy for Managing Emotions
T2
|
50.00 units on a scale
Standard Deviation 9.30
|
49.18 units on a scale
Standard Deviation 9.93
|
|
PROMIS Self-efficacy for Managing Emotions
T3
|
50.15 units on a scale
Standard Deviation 8.78
|
49.90 units on a scale
Standard Deviation 8.77
|
|
PROMIS Self-efficacy for Managing Emotions
T4
|
51.85 units on a scale
Standard Deviation 9.37
|
51.70 units on a scale
Standard Deviation 8.79
|
|
PROMIS Self-efficacy for Managing Emotions
T5
|
—
|
51.01 units on a scale
Standard Deviation 8.45
|
SECONDARY outcome
Timeframe: 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)Population: The number of valid data points varied across individuals, as well as by time and by variable within each individual, because participants could 1) miss a data collection but complete subsequent data collection(s) and/or 2) choose not to complete a physical test or a survey question.
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.
Outcome measures
| Measure |
Intervention Arm
n=103 Participants
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.
baa nnilah: 7 meetings in the community led by a trained community facilitator
|
Wait-list Control Arm
n=106 Participants
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.
baa nnilah: 7 meetings in the community led by a trained community facilitator
|
|---|---|---|
|
PROMIS Self-efficacy for Managing Social Interactions
T1
|
46.57 units on a scale
Standard Deviation 8.57
|
47.44 units on a scale
Standard Deviation 9.74
|
|
PROMIS Self-efficacy for Managing Social Interactions
T2
|
47.13 units on a scale
Standard Deviation 8.54
|
47.86 units on a scale
Standard Deviation 8.99
|
|
PROMIS Self-efficacy for Managing Social Interactions
T3
|
48.57 units on a scale
Standard Deviation 9.10
|
47.18 units on a scale
Standard Deviation 9.74
|
|
PROMIS Self-efficacy for Managing Social Interactions
T4
|
47.29 units on a scale
Standard Deviation 8.94
|
49.20 units on a scale
Standard Deviation 8.58
|
|
PROMIS Self-efficacy for Managing Social Interactions
T5
|
—
|
49.17 units on a scale
Standard Deviation 8.60
|
SECONDARY outcome
Timeframe: 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)Population: The number of valid data points varied across individuals, as well as by time and by variable within each individual, because participants could 1) miss a data collection but complete subsequent data collection(s) and/or 2) choose not to complete a physical test or a survey question.
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.
Outcome measures
| Measure |
Intervention Arm
n=104 Participants
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.
baa nnilah: 7 meetings in the community led by a trained community facilitator
|
Wait-list Control Arm
n=107 Participants
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.
baa nnilah: 7 meetings in the community led by a trained community facilitator
|
|---|---|---|
|
Patient Activation Measure
T2
|
67.53 units on a scale
Standard Deviation 21.22
|
70.61 units on a scale
Standard Deviation 19.66
|
|
Patient Activation Measure
T1
|
69.31 units on a scale
Standard Deviation 17.73
|
65.50 units on a scale
Standard Deviation 16.41
|
|
Patient Activation Measure
T3
|
68.47 units on a scale
Standard Deviation 20.88
|
71.67 units on a scale
Standard Deviation 17.97
|
|
Patient Activation Measure
T4
|
67.05 units on a scale
Standard Deviation 17.91
|
71.57 units on a scale
Standard Deviation 18.59
|
SECONDARY outcome
Timeframe: 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)Population: The number of valid data points varied across individuals, as well as by time and by variable within each individual, because participants could 1) miss a data collection but complete subsequent data collection(s) and/or 2) choose not to complete a physical test or a survey question.
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.
Outcome measures
| Measure |
Intervention Arm
n=99 Participants
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.
baa nnilah: 7 meetings in the community led by a trained community facilitator
|
Wait-list Control Arm
n=105 Participants
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.
baa nnilah: 7 meetings in the community led by a trained community facilitator
|
|---|---|---|
|
Modified Timed Up and Go
T1
|
20.83 seconds
Standard Deviation 5.43
|
20.39 seconds
Standard Deviation 5.30
|
|
Modified Timed Up and Go
T2
|
19.26 seconds
Standard Deviation 5.08
|
19.34 seconds
Standard Deviation 4.31
|
|
Modified Timed Up and Go
T3
|
17.18 seconds
Standard Deviation 5.51
|
18.70 seconds
Standard Deviation 7.30
|
|
Modified Timed Up and Go
T4
|
18.42 seconds
Standard Deviation 4.27
|
18.26 seconds
Standard Deviation 3.79
|
|
Modified Timed Up and Go
T5
|
—
|
19.06 seconds
Standard Deviation 4.58
|
SECONDARY outcome
Timeframe: 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)Population: The number of valid data points varied across individuals, as well as by time and by variable within each individual, because participants could 1) miss a data collection but complete subsequent data collection(s) and/or 2) choose not to complete a physical test or a survey question.
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.
Outcome measures
| Measure |
Intervention Arm
n=90 Participants
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.
baa nnilah: 7 meetings in the community led by a trained community facilitator
|
Wait-list Control Arm
n=106 Participants
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.
baa nnilah: 7 meetings in the community led by a trained community facilitator
|
|---|---|---|
|
Modified Balance Error Scoring System
T1
|
13.41 total number of errors over three trials
Standard Deviation 6.33
|
13.81 total number of errors over three trials
Standard Deviation 6.60
|
|
Modified Balance Error Scoring System
T2
|
14.17 total number of errors over three trials
Standard Deviation 7.22
|
12.68 total number of errors over three trials
Standard Deviation 6.59
|
|
Modified Balance Error Scoring System
T3
|
15.30 total number of errors over three trials
Standard Deviation 10.26
|
11.91 total number of errors over three trials
Standard Deviation 10.57
|
|
Modified Balance Error Scoring System
T4
|
20.96 total number of errors over three trials
Standard Deviation 8.87
|
21.03 total number of errors over three trials
Standard Deviation 9.44
|
|
Modified Balance Error Scoring System
T5
|
—
|
13.38 total number of errors over three trials
Standard Deviation 6.94
|
SECONDARY outcome
Timeframe: 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)Population: The number of valid data points varied across individuals, as well as by time and by variable within each individual, because participants could 1) miss a data collection but complete subsequent data collection(s) and/or 2) choose not to complete a physical test or a survey question.
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.
Outcome measures
| Measure |
Intervention Arm
n=97 Participants
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.
baa nnilah: 7 meetings in the community led by a trained community facilitator
|
Wait-list Control Arm
n=98 Participants
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.
baa nnilah: 7 meetings in the community led by a trained community facilitator
|
|---|---|---|
|
6-minute Walk
T2
|
1336.75 feet
Standard Deviation 273.48
|
1358.96 feet
Standard Deviation 323.35
|
|
6-minute Walk
T1
|
1260.23 feet
Standard Deviation 287.70
|
1298.85 feet
Standard Deviation 265.40
|
|
6-minute Walk
T3
|
1060.11 feet
Standard Deviation 603.53
|
1283.54 feet
Standard Deviation 449.10
|
|
6-minute Walk
T4
|
1312.84 feet
Standard Deviation 379.76
|
1334.98 feet
Standard Deviation 284.74
|
|
6-minute Walk
T5
|
—
|
1287.08 feet
Standard Deviation 320.25
|
Adverse Events
Intervention Arm
Wait-list Control Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place