Trial Outcomes & Findings for Peer i-Coaching for Activated Self-Management Optimization in Adolescents and Young Adults With Chronic Conditions (NCT NCT03938324)
NCT ID: NCT03938324
Last Updated: 2025-07-28
Results Overview
Self-management variable measured using the Partners in Health Scale (PIH): measures chronic illness self-management by assessing chronic condition self-management knowledge, partnership in treatment, recognition and management of symptoms, and coping. This 12 item self-report scale is scored on a 9-point Likert scale. The primary outcome is the overall score, which is the mean of the 12 items (possible range of 0 to 8, higher overall scores indicating better self-management).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
222 participants
Primary outcome timeframe
baseline, 3, 6, 9, and 12 months
Results posted on
2025-07-28
Participant Flow
Participant milestones
| Measure |
PiCASO Intervention Group
Peer coaching intervention delivered by young adults with a childhood onset chronic condition and trained in coaching curriculum that includes motivational interviewing techniques and the benefits of peer relationships over a shared experience such as a chronic condition. The peer coach supports the AYA to identify their goals and feel a sense of success in making change towards goals within a supportive environment. This process involves goal-setting, development of self-discovery and accountability for changes in health behavior. The peer coach elicits the AYA's vision of optimal health and identifies the AYAs values. As the AYAs identify a vision of wellness and develop goals and action steps to progress towards that vision, the peer coach elicits the AYA's intrinsic motivation and activates skill development in self-advocacy and communication and empowers the AYA to take leadership in managing their condition.
|
Attention Control Group
Over 12 months the attention control group participants will receive a monthly electronic newsletter with educational content about childhood onset chronic condition management and the differences between pediatric and adult health care systems, as well as a monthly phone call from study staff to ensure receipt of the newsletter and to answer questions regarding content, and an opportunity to link them to other resources. If participants report health concerns they will be directed to contact their health care team.
Sham Comparator: Attention Control Group: Over 12 months the attention control group participants will receive a monthly electronic newsletter with educational content about childhood onset chronic condition management and the differences between pediatric and adult health care systems, as well as a monthly phone call from study staff to ensure receipt of the newsletter and to answer questions regarding content, and an opportunity to link them to other resources. If participants report health concerns they will be directed to contact their health care team.
|
|---|---|---|
|
Overall Study
STARTED
|
147
|
75
|
|
Overall Study
COMPLETED
|
99
|
53
|
|
Overall Study
NOT COMPLETED
|
48
|
22
|
Reasons for withdrawal
| Measure |
PiCASO Intervention Group
Peer coaching intervention delivered by young adults with a childhood onset chronic condition and trained in coaching curriculum that includes motivational interviewing techniques and the benefits of peer relationships over a shared experience such as a chronic condition. The peer coach supports the AYA to identify their goals and feel a sense of success in making change towards goals within a supportive environment. This process involves goal-setting, development of self-discovery and accountability for changes in health behavior. The peer coach elicits the AYA's vision of optimal health and identifies the AYAs values. As the AYAs identify a vision of wellness and develop goals and action steps to progress towards that vision, the peer coach elicits the AYA's intrinsic motivation and activates skill development in self-advocacy and communication and empowers the AYA to take leadership in managing their condition.
|
Attention Control Group
Over 12 months the attention control group participants will receive a monthly electronic newsletter with educational content about childhood onset chronic condition management and the differences between pediatric and adult health care systems, as well as a monthly phone call from study staff to ensure receipt of the newsletter and to answer questions regarding content, and an opportunity to link them to other resources. If participants report health concerns they will be directed to contact their health care team.
Sham Comparator: Attention Control Group: Over 12 months the attention control group participants will receive a monthly electronic newsletter with educational content about childhood onset chronic condition management and the differences between pediatric and adult health care systems, as well as a monthly phone call from study staff to ensure receipt of the newsletter and to answer questions regarding content, and an opportunity to link them to other resources. If participants report health concerns they will be directed to contact their health care team.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
42
|
21
|
|
Overall Study
Withdrawal by Subject
|
6
|
1
|
Baseline Characteristics
Peer i-Coaching for Activated Self-Management Optimization in Adolescents and Young Adults With Chronic Conditions
Baseline characteristics by cohort
| Measure |
PiCASO Intervention Group
n=147 Participants
Peer coaching intervention delivered by young adults with a childhood onset chronic condition and trained in coaching curriculum that includes motivational interviewing techniques and the benefits of peer relationships over a shared experience such as a chronic condition. The peer coach supports the AYA to identify their goals and feel a sense of success in making change towards goals within a supportive environment. This process involves goal-setting, development of self-discovery and accountability for changes in health behavior. The peer coach elicits the AYA's vision of optimal health and identifies the AYAs values. As the AYAs identify a vision of wellness and develop goals and action steps to progress towards that vision, the peer coach elicits the AYA's intrinsic motivation and activates skill development in self-advocacy and communication and empowers the AYA to take leadership in managing their condition.
|
Attention Control Group
n=75 Participants
Over 12 months the attention control group participants will receive a monthly electronic newsletter with educational content about childhood onset chronic condition management and the differences between pediatric and adult health care systems, as well as a monthly phone call from study staff to ensure receipt of the newsletter and to answer questions regarding content, and an opportunity to link them to other resources. If participants report health concerns they will be directed to contact their health care team.
Sham Comparator: Attention Control Group: Over 12 months the attention control group participants will receive a monthly electronic newsletter with educational content about childhood onset chronic condition management and the differences between pediatric and adult health care systems, as well as a monthly phone call from study staff to ensure receipt of the newsletter and to answer questions regarding content, and an opportunity to link them to other resources. If participants report health concerns they will be directed to contact their health care team.
|
Total
n=222 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
18.4 years
STANDARD_DEVIATION 1.9 • n=5 Participants
|
18.3 years
STANDARD_DEVIATION 1.7 • n=7 Participants
|
18.4 years
STANDARD_DEVIATION 1.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
93 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
134 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
199 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
67 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
58 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
147 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
222 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, 3, 6, 9, and 12 monthsSelf-management variable measured using the Partners in Health Scale (PIH): measures chronic illness self-management by assessing chronic condition self-management knowledge, partnership in treatment, recognition and management of symptoms, and coping. This 12 item self-report scale is scored on a 9-point Likert scale. The primary outcome is the overall score, which is the mean of the 12 items (possible range of 0 to 8, higher overall scores indicating better self-management).
Outcome measures
| Measure |
PiCASO Intervention Group
n=147 Participants
Peer coaching intervention delivered by young adults with a childhood onset chronic condition and trained in coaching curriculum that includes motivational interviewing techniques and the benefits of peer relationships over a shared experience such as a chronic condition. The peer coach supports the AYA to identify their goals and feel a sense of success in making change towards goals within a supportive environment. This process involves goal-setting, development of self-discovery and accountability for changes in health behavior. The peer coach elicits the AYA's vision of optimal health and identifies the AYAs values. As the AYAs identify a vision of wellness and develop goals and action steps to progress towards that vision, the peer coach elicits the AYA's intrinsic motivation and activates skill development in self-advocacy and communication and empowers the AYA to take leadership in managing their condition.
|
Attention Control Group
n=75 Participants
Over 12 months the attention control group participants will receive a monthly electronic newsletter with educational content about childhood onset chronic condition management and the differences between pediatric and adult health care systems, as well as a monthly phone call from study staff to ensure receipt of the newsletter and to answer questions regarding content, and an opportunity to link them to other resources. If participants report health concerns they will be directed to contact their health care team.
Sham Comparator: Attention Control Group: Over 12 months the attention control group participants will receive a monthly electronic newsletter with educational content about childhood onset chronic condition management and the differences between pediatric and adult health care systems, as well as a monthly phone call from study staff to ensure receipt of the newsletter and to answer questions regarding content, and an opportunity to link them to other resources. If participants report health concerns they will be directed to contact their health care team.
|
|---|---|---|
|
Change in Self-management as Measured by the Partners in Health Scale
Baseline
|
6.7 score on a scale
Standard Deviation 0.7
|
6.5 score on a scale
Standard Deviation 0.8
|
|
Change in Self-management as Measured by the Partners in Health Scale
3 months
|
6.8 score on a scale
Standard Deviation 0.7
|
6.6 score on a scale
Standard Deviation 0.8
|
|
Change in Self-management as Measured by the Partners in Health Scale
6 months
|
6.9 score on a scale
Standard Deviation 0.8
|
6.6 score on a scale
Standard Deviation 0.8
|
|
Change in Self-management as Measured by the Partners in Health Scale
9 months
|
7.0 score on a scale
Standard Deviation 0.8
|
6.6 score on a scale
Standard Deviation 0.8
|
|
Change in Self-management as Measured by the Partners in Health Scale
12 months
|
7.1 score on a scale
Standard Deviation 0.8
|
6.6 score on a scale
Standard Deviation 0.9
|
PRIMARY outcome
Timeframe: baseline, 3, 6, 9, and 12 monthsPatient Activation variable measured using the Patient Activation Measure (PAM-13): measures patient activation through self-reports of knowledge, skills, and confidence related to self-management of one's own health care. This 13-item self-report assesses confidence in self-management and understanding of health condition. Each of the 13 items scored on a 5-point Likert scale. The primary outcome is an activation score derived from the 13 items (possible range of 0-100, higher scores indicating higher patient activation in self-management).
Outcome measures
| Measure |
PiCASO Intervention Group
n=147 Participants
Peer coaching intervention delivered by young adults with a childhood onset chronic condition and trained in coaching curriculum that includes motivational interviewing techniques and the benefits of peer relationships over a shared experience such as a chronic condition. The peer coach supports the AYA to identify their goals and feel a sense of success in making change towards goals within a supportive environment. This process involves goal-setting, development of self-discovery and accountability for changes in health behavior. The peer coach elicits the AYA's vision of optimal health and identifies the AYAs values. As the AYAs identify a vision of wellness and develop goals and action steps to progress towards that vision, the peer coach elicits the AYA's intrinsic motivation and activates skill development in self-advocacy and communication and empowers the AYA to take leadership in managing their condition.
|
Attention Control Group
n=75 Participants
Over 12 months the attention control group participants will receive a monthly electronic newsletter with educational content about childhood onset chronic condition management and the differences between pediatric and adult health care systems, as well as a monthly phone call from study staff to ensure receipt of the newsletter and to answer questions regarding content, and an opportunity to link them to other resources. If participants report health concerns they will be directed to contact their health care team.
Sham Comparator: Attention Control Group: Over 12 months the attention control group participants will receive a monthly electronic newsletter with educational content about childhood onset chronic condition management and the differences between pediatric and adult health care systems, as well as a monthly phone call from study staff to ensure receipt of the newsletter and to answer questions regarding content, and an opportunity to link them to other resources. If participants report health concerns they will be directed to contact their health care team.
|
|---|---|---|
|
Patient Activation as Measured by the Patient Activation Measure (PAM-13)
Baseline
|
70.0 score on a scale
Standard Deviation 8.4
|
68.8 score on a scale
Standard Deviation 8.7
|
|
Patient Activation as Measured by the Patient Activation Measure (PAM-13)
3 months
|
72.4 score on a scale
Standard Deviation 9.2
|
70.8 score on a scale
Standard Deviation 9.6
|
|
Patient Activation as Measured by the Patient Activation Measure (PAM-13)
6 months
|
74.9 score on a scale
Standard Deviation 10.0
|
72.8 score on a scale
Standard Deviation 10.4
|
|
Patient Activation as Measured by the Patient Activation Measure (PAM-13)
9 months
|
77.3 score on a scale
Standard Deviation 10.9
|
74.8 score on a scale
Standard Deviation 11.3
|
|
Patient Activation as Measured by the Patient Activation Measure (PAM-13)
12 months
|
79.8 score on a scale
Standard Deviation 11.7
|
76.8 score on a scale
Standard Deviation 12.1
|
SECONDARY outcome
Timeframe: baseline, 3, 6, 9, and 12 monthsTransition readiness variable measured using Transition Readiness Assessment Questionnaire (TRAQ 20): 20-item self-report assessment of the ability to make appointments, manage medications, track health issues, talk with providers, and manage daily activities. Each item is scored 1-5 on a Likert scale. The primary outcome is the overall score, calculated as the mean of the 20 items (possible range: 1 to 5, higher scores indicating more transition readiness).
Outcome measures
| Measure |
PiCASO Intervention Group
n=147 Participants
Peer coaching intervention delivered by young adults with a childhood onset chronic condition and trained in coaching curriculum that includes motivational interviewing techniques and the benefits of peer relationships over a shared experience such as a chronic condition. The peer coach supports the AYA to identify their goals and feel a sense of success in making change towards goals within a supportive environment. This process involves goal-setting, development of self-discovery and accountability for changes in health behavior. The peer coach elicits the AYA's vision of optimal health and identifies the AYAs values. As the AYAs identify a vision of wellness and develop goals and action steps to progress towards that vision, the peer coach elicits the AYA's intrinsic motivation and activates skill development in self-advocacy and communication and empowers the AYA to take leadership in managing their condition.
|
Attention Control Group
n=75 Participants
Over 12 months the attention control group participants will receive a monthly electronic newsletter with educational content about childhood onset chronic condition management and the differences between pediatric and adult health care systems, as well as a monthly phone call from study staff to ensure receipt of the newsletter and to answer questions regarding content, and an opportunity to link them to other resources. If participants report health concerns they will be directed to contact their health care team.
Sham Comparator: Attention Control Group: Over 12 months the attention control group participants will receive a monthly electronic newsletter with educational content about childhood onset chronic condition management and the differences between pediatric and adult health care systems, as well as a monthly phone call from study staff to ensure receipt of the newsletter and to answer questions regarding content, and an opportunity to link them to other resources. If participants report health concerns they will be directed to contact their health care team.
|
|---|---|---|
|
Change in Transition Readiness as Measured by the Transition Readiness Questionnaire (TRAQ 20)
Baseline
|
4.1 score on a scale
Standard Deviation 0.5
|
3.9 score on a scale
Standard Deviation 0.5
|
|
Change in Transition Readiness as Measured by the Transition Readiness Questionnaire (TRAQ 20)
3 months
|
4.2 score on a scale
Standard Deviation 0.4
|
4.0 score on a scale
Standard Deviation 0.5
|
|
Change in Transition Readiness as Measured by the Transition Readiness Questionnaire (TRAQ 20)
6 months
|
4.3 score on a scale
Standard Deviation 0.4
|
4.1 score on a scale
Standard Deviation 0.5
|
|
Change in Transition Readiness as Measured by the Transition Readiness Questionnaire (TRAQ 20)
9 months
|
4.4 score on a scale
Standard Deviation 0.4
|
4.1 score on a scale
Standard Deviation 0.5
|
|
Change in Transition Readiness as Measured by the Transition Readiness Questionnaire (TRAQ 20)
12 months
|
4.4 score on a scale
Standard Deviation 0.4
|
4.2 score on a scale
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: baseline, 3, 6, 9, and 12 monthsHealth-related Quality of Life variable measured using the Short Form Health Survey (SF12): 12-item self-report that assesses health related quality of life. The sum of the MCS items was transformed into T-scores for comparison to the US population (which has a mean of 50 and standard deviation of 10). The MCS T-scores have a range of 0 to 100, with higher scores indicating better mental health status.
Outcome measures
| Measure |
PiCASO Intervention Group
n=147 Participants
Peer coaching intervention delivered by young adults with a childhood onset chronic condition and trained in coaching curriculum that includes motivational interviewing techniques and the benefits of peer relationships over a shared experience such as a chronic condition. The peer coach supports the AYA to identify their goals and feel a sense of success in making change towards goals within a supportive environment. This process involves goal-setting, development of self-discovery and accountability for changes in health behavior. The peer coach elicits the AYA's vision of optimal health and identifies the AYAs values. As the AYAs identify a vision of wellness and develop goals and action steps to progress towards that vision, the peer coach elicits the AYA's intrinsic motivation and activates skill development in self-advocacy and communication and empowers the AYA to take leadership in managing their condition.
|
Attention Control Group
n=75 Participants
Over 12 months the attention control group participants will receive a monthly electronic newsletter with educational content about childhood onset chronic condition management and the differences between pediatric and adult health care systems, as well as a monthly phone call from study staff to ensure receipt of the newsletter and to answer questions regarding content, and an opportunity to link them to other resources. If participants report health concerns they will be directed to contact their health care team.
Sham Comparator: Attention Control Group: Over 12 months the attention control group participants will receive a monthly electronic newsletter with educational content about childhood onset chronic condition management and the differences between pediatric and adult health care systems, as well as a monthly phone call from study staff to ensure receipt of the newsletter and to answer questions regarding content, and an opportunity to link them to other resources. If participants report health concerns they will be directed to contact their health care team.
|
|---|---|---|
|
Change in Health-related Quality of Life as Measured by the Short Form Health Survey (SF12) - Mental Component Summary (MCS)
Baseline
|
45.5 T-score
Standard Deviation 8.1
|
45.1 T-score
Standard Deviation 8.3
|
|
Change in Health-related Quality of Life as Measured by the Short Form Health Survey (SF12) - Mental Component Summary (MCS)
3 months
|
46.1 T-score
Standard Deviation 7.8
|
45.1 T-score
Standard Deviation 8.1
|
|
Change in Health-related Quality of Life as Measured by the Short Form Health Survey (SF12) - Mental Component Summary (MCS)
6 months
|
46.7 T-score
Standard Deviation 7.5
|
45.1 T-score
Standard Deviation 7.9
|
|
Change in Health-related Quality of Life as Measured by the Short Form Health Survey (SF12) - Mental Component Summary (MCS)
9 months
|
47.2 T-score
Standard Deviation 7.3
|
45.1 T-score
Standard Deviation 7.7
|
|
Change in Health-related Quality of Life as Measured by the Short Form Health Survey (SF12) - Mental Component Summary (MCS)
12 months
|
47.8 T-score
Standard Deviation 7.2
|
45.1 T-score
Standard Deviation 7.8
|
SECONDARY outcome
Timeframe: baseline, 3, 6, 9, and 12 monthsEmotional health variable measured using the Brief Symptom Inventory: 18-item self-report of emotional symptoms experienced over the previous 7 days. Each item was scored with 0 to 4 Likert scale. The primary outcome was the global severity index score (GSI), an overall score derived by summing the scores of the 18 items (possible range: 0 to 72 with higher scores indicating greater psychological distress).
Outcome measures
| Measure |
PiCASO Intervention Group
n=147 Participants
Peer coaching intervention delivered by young adults with a childhood onset chronic condition and trained in coaching curriculum that includes motivational interviewing techniques and the benefits of peer relationships over a shared experience such as a chronic condition. The peer coach supports the AYA to identify their goals and feel a sense of success in making change towards goals within a supportive environment. This process involves goal-setting, development of self-discovery and accountability for changes in health behavior. The peer coach elicits the AYA's vision of optimal health and identifies the AYAs values. As the AYAs identify a vision of wellness and develop goals and action steps to progress towards that vision, the peer coach elicits the AYA's intrinsic motivation and activates skill development in self-advocacy and communication and empowers the AYA to take leadership in managing their condition.
|
Attention Control Group
n=75 Participants
Over 12 months the attention control group participants will receive a monthly electronic newsletter with educational content about childhood onset chronic condition management and the differences between pediatric and adult health care systems, as well as a monthly phone call from study staff to ensure receipt of the newsletter and to answer questions regarding content, and an opportunity to link them to other resources. If participants report health concerns they will be directed to contact their health care team.
Sham Comparator: Attention Control Group: Over 12 months the attention control group participants will receive a monthly electronic newsletter with educational content about childhood onset chronic condition management and the differences between pediatric and adult health care systems, as well as a monthly phone call from study staff to ensure receipt of the newsletter and to answer questions regarding content, and an opportunity to link them to other resources. If participants report health concerns they will be directed to contact their health care team.
|
|---|---|---|
|
Change in Emotional Health as Measured by the Brief Symptom Inventory (BSI 18)
Baseline
|
9.7 score on a scale
Standard Deviation 8.7
|
10.7 score on a scale
Standard Deviation 7.9
|
|
Change in Emotional Health as Measured by the Brief Symptom Inventory (BSI 18)
3 months
|
9.5 score on a scale
Standard Deviation 9.0
|
10.5 score on a scale
Standard Deviation 8.1
|
|
Change in Emotional Health as Measured by the Brief Symptom Inventory (BSI 18)
6 months
|
9.3 score on a scale
Standard Deviation 9.3
|
10.4 score on a scale
Standard Deviation 8.5
|
|
Change in Emotional Health as Measured by the Brief Symptom Inventory (BSI 18)
9 months
|
9.0 score on a scale
Standard Deviation 9.8
|
10.3 score on a scale
Standard Deviation 8.9
|
|
Change in Emotional Health as Measured by the Brief Symptom Inventory (BSI 18)
12 months
|
8.8 score on a scale
Standard Deviation 10.4
|
10.2 score on a scale
Standard Deviation 9.5
|
Adverse Events
PiCASO Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Attention Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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