TriangleNCT03938324 · OUTCOME
Change in Health-related Quality of Life as Measured by the Short Form Health Survey (SF12) - Mental Component Summary (MCS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- T-score
- Interval / dispersion
- Standard Deviation
- Time frame
- baseline, 3, 6, 9, and 12 months
What was measured
Health-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.
Groups in this outcome
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.
| Group | Source count |
|---|---|
| PiCASO Intervention Group | 147 |
| Attention Control Group | 75 |
Reported measurements
Baseline
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| PiCASO Intervention Group | 45.5 | 8.1 | Not reported | Not reported | Not reported |
| Attention Control Group | 45.1 | 8.3 | Not reported | Not reported | Not reported |
3 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| PiCASO Intervention Group | 46.1 | 7.8 | Not reported | Not reported | Not reported |
| Attention Control Group | 45.1 | 8.1 | Not reported | Not reported | Not reported |
6 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| PiCASO Intervention Group | 46.7 | 7.5 | Not reported | Not reported | Not reported |
| Attention Control Group | 45.1 | 7.9 | Not reported | Not reported | Not reported |
9 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| PiCASO Intervention Group | 47.2 | 7.3 | Not reported | Not reported | Not reported |
| Attention Control Group | 45.1 | 7.7 | Not reported | Not reported | Not reported |
12 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| PiCASO Intervention Group | 47.8 | 7.2 | Not reported | Not reported | Not reported |
| Attention Control Group | 45.1 | 7.8 | Not reported | Not reported | Not reported |
Source statistical analyses
- group Description
- Multi-level mixed effects model for longitudinal data to compare treatment group difference in trajectory across 12 months. Group sizes provided at least 80% power to detect a true difference in change trajectories (treatment-by-time interaction effect), assuming a medium effect size, two-tailed tests, and statistical significance set at 0.05. Null hypothesis was no treatment group difference in the trajectory from baseline to 12 months (no significant treatment-by-time effect).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.1708
- p Value Comment
- The two-tailed significance set at 0.05 was not adjusted for multiple outcomes or comparisons. No adjustments for pairwise comparisons were required for the model.
- statistical Comment
- Fixed effects were treatment, time, treatment-by time; whereas, random effects were participant and participant-by-time.
- statistical Method
- Multi-level mixed effects
Complete source fields
- analyses
- group Description
- Multi-level mixed effects model for longitudinal data to compare treatment group difference in trajectory across 12 months. Group sizes provided at least 80% power to detect a true difference in change trajectories (treatment-by-time interaction effect), assuming a medium effect size, two-tailed tests, and statistical significance set at 0.05. Null hypothesis was no treatment group difference in the trajectory from baseline to 12 months (no significant treatment-by-time effect).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.1708
- p Value Comment
- The two-tailed significance set at 0.05 was not adjusted for multiple outcomes or comparisons. No adjustments for pairwise comparisons were required for the model.
- statistical Comment
- Fixed effects were treatment, time, treatment-by time; whereas, random effects were participant and participant-by-time.
- statistical Method
- Multi-level mixed effects
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 8.1
- value
- 45.5
- group Id
- OG001
- spread
- 8.3
- value
- 45.1
- title
- Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 7.8
- value
- 46.1
- group Id
- OG001
- spread
- 8.1
- value
- 45.1
- title
- 3 months
- categories
- measurements
- group Id
- OG000
- spread
- 7.5
- value
- 46.7
- group Id
- OG001
- spread
- 7.9
- value
- 45.1
- title
- 6 months
- categories
- measurements
- group Id
- OG000
- spread
- 7.3
- value
- 47.2
- group Id
- OG001
- spread
- 7.7
- value
- 45.1
- title
- 9 months
- categories
- measurements
- group Id
- OG000
- spread
- 7.2
- value
- 47.8
- group Id
- OG001
- spread
- 7.8
- value
- 45.1
- title
- 12 months
- denoms
- counts
- group Id
- OG000
- value
- 147
- group Id
- OG001
- value
- 75
- units
- Participants
- description
- Health-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.
- dispersion Type
- Standard Deviation
- groups
- description
- 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.
- id
- OG000
- title
- PiCASO Intervention Group
- description
- 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.
- id
- OG001
- title
- Attention Control Group
- param Type
- MEAN
- reporting Status
- POSTED
- time Frame
- baseline, 3, 6, 9, and 12 months
- title
- Change in Health-related Quality of Life as Measured by the Short Form Health Survey (SF12) - Mental Component Summary (MCS)
- type
- SECONDARY
- unit Of Measure
- T-score
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice