Adults 16 to 22, any sex, with Sickle Cell Disease or Chronic Kidney Diseases. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Self-management as Measured by the Partners in Health ScalePrimary· baseline, 3, 6, 9, and 12 months
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).
Baseline
Group
Value
95% CI
PiCASO Intervention Group
6.7
± 0.7
Attention Control Group
6.5
± 0.8
3 months
Group
Value
95% CI
PiCASO Intervention Group
6.8
± 0.7
Attention Control Group
6.6
± 0.8
6 months
Group
Value
95% CI
PiCASO Intervention Group
6.9
± 0.8
Attention Control Group
6.6
± 0.8
9 months
Group
Value
95% CI
PiCASO Intervention Group
7.0
± 0.8
Attention Control Group
6.6
± 0.8
12 months
Group
Value
95% CI
PiCASO Intervention Group
7.1
± 0.8
Attention Control Group
6.6
± 0.9
Patient Activation as Measured by the Patient Activation Measure (PAM-13)Primary· baseline, 3, 6, 9, and 12 months
Patient 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).
Baseline
Group
Value
95% CI
PiCASO Intervention Group
70.0
± 8.4
Attention Control Group
68.8
± 8.7
3 months
Group
Value
95% CI
PiCASO Intervention Group
72.4
± 9.2
Attention Control Group
70.8
± 9.6
6 months
Group
Value
95% CI
PiCASO Intervention Group
74.9
± 10.0
Attention Control Group
72.8
± 10.4
9 months
Group
Value
95% CI
PiCASO Intervention Group
77.3
± 10.9
Attention Control Group
74.8
± 11.3
12 months
Group
Value
95% CI
PiCASO Intervention Group
79.8
± 11.7
Attention Control Group
76.8
± 12.1
Change in Transition Readiness as Measured by the Transition Readiness Questionnaire (TRAQ 20)Secondary· baseline, 3, 6, 9, and 12 months
Transition 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).
Baseline
Group
Value
95% CI
PiCASO Intervention Group
4.1
± 0.5
Attention Control Group
3.9
± 0.5
3 months
Group
Value
95% CI
PiCASO Intervention Group
4.2
± 0.4
Attention Control Group
4.0
± 0.5
6 months
Group
Value
95% CI
PiCASO Intervention Group
4.3
± 0.4
Attention Control Group
4.1
± 0.5
9 months
Group
Value
95% CI
PiCASO Intervention Group
4.4
± 0.4
Attention Control Group
4.1
± 0.5
12 months
Group
Value
95% CI
PiCASO Intervention Group
4.4
± 0.4
Attention Control Group
4.2
± 0.4
Change in Health-related Quality of Life as Measured by the Short Form Health Survey (SF12) - Mental Component Summary (MCS)Secondary· baseline, 3, 6, 9, and 12 months
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.
Baseline
Group
Value
95% CI
PiCASO Intervention Group
45.5
± 8.1
Attention Control Group
45.1
± 8.3
3 months
Group
Value
95% CI
PiCASO Intervention Group
46.1
± 7.8
Attention Control Group
45.1
± 8.1
6 months
Group
Value
95% CI
PiCASO Intervention Group
46.7
± 7.5
Attention Control Group
45.1
± 7.9
9 months
Group
Value
95% CI
PiCASO Intervention Group
47.2
± 7.3
Attention Control Group
45.1
± 7.7
12 months
Group
Value
95% CI
PiCASO Intervention Group
47.8
± 7.2
Attention Control Group
45.1
± 7.8
Change in Emotional Health as Measured by the Brief Symptom Inventory (BSI 18)Secondary· baseline, 3, 6, 9, and 12 months
Emotional 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).
Baseline
Group
Value
95% CI
PiCASO Intervention Group
9.7
± 8.7
Attention Control Group
10.7
± 7.9
3 months
Group
Value
95% CI
PiCASO Intervention Group
9.5
± 9.0
Attention Control Group
10.5
± 8.1
6 months
Group
Value
95% CI
PiCASO Intervention Group
9.3
± 9.3
Attention Control Group
10.4
± 8.5
9 months
Group
Value
95% CI
PiCASO Intervention Group
9.0
± 9.8
Attention Control Group
10.3
± 8.9
12 months
Group
Value
95% CI
PiCASO Intervention Group
8.8
± 10.4
Attention Control Group
10.2
± 9.5
Sponsor's own description
The purpose of this study is to test the efficacy of a peer support coaching intervention to improve activated chronic illness self-management versus an attention control group in 225 adolescents and young adults with childhood onset chronic conditions.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Duke University
Last refreshed: 28 July 2025
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