- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03938324
Peer i-Coaching for Activated Self-Management Optimization in Adolescents and Young Adults With Chronic Conditions (PiCASO)
January 24, 2024 updated by: Duke University
Peer i-Coaching for Activated Self-management Optimization in Adolescents and Young Adults With Chronic Conditions
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Increases in life expectancy in almost all childhood-onset chronic conditions (COCC) has brought unique challenges for adolescents and young adults (AYA) who struggle to deal with the associated disease burden, manage therapies, and thrive as they develop independent self-management skills, and become active and engaged patients.
The challenges that influence the lives of AYAs are largely adaptive, such as making lifestyle modifications, adhering to complex medication regimens, and learning to navigate the adult health system.
Adding to this complexity is the need for AYAs to progressively take over greater self-management responsibilities from parents.
Promoting activated self-management is critically important given that this shift in health care management from parents and health care providers to the AYA is identified as key to successful adult outcomes.
Peer support interventions are well-suited to address challenges theorized as critical to AYAs given the importance of peer relationships during this time.
The investigators propose a mixed-methods, five-year randomized controlled trial, that will include 225 AYAs (16-22 years) with COCCs, to test the Peer i-Coaching for Activated Self-Management Optimization (PICASO) versus an attention control group.
This novel, mobile health intervention utilizes an established telephone/text based secure interface to allow AYAs access knowledge, experience, and instrumental/emotional support from a trained peer coach (18-26 years), who has already developed independence and is an active self-manager.
The investigators will determine the efficacy of PICASO on self-management, patient activation, transition readiness, health-related quality, and emotional health of life across 12 months.
The investigators will explore whether age, sex, race/ethnicity, chronic condition, and/or disease severity moderate the trajectory of PICASO effects on self-management, patient activation, coping, emotional health and health-related quality of life.
Lastly, the investigators will explore mechanisms of the PICASO impact by describing AYA experiences with the intervention.
Study Type
Interventional
Enrollment (Actual)
222
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sharron L Docherty, PhD
- Phone Number: 919-668-3836
- Email: sharron.docherty@duke.edu
Study Contact Backup
- Name: Gary Maslow, MD
- Phone Number: 919-797-5363
- Email: gary.maslow@duke.edu
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27710
- Duke University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 22 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- AYA 16 to 22 years
- Childhood onset chronic condition from 1 of 3 condition categories
- Read and speaks English
- Access to internet via computer or Smart Phone
- Access to telephone (Smart Phone not required as text feature can be accessed via internet)
Exclusion Criteria:
- Diagnosed cognitive dysfunction
- Need for English translator
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
This mobile health intervention utilizes an established telephone/text based secure interface to allow AYAs access knowledge, experience, and instrumental/emotional support from a trained peer coach who has already developed independence an active self-manager.
Peers with shared experiences provide instrumental (e.g., health maintenance skills) and emotional support that likely lead to improvements in quality of life.
Involving peers in supporting AYAs with chronic conditions to promote self-management and patient activation disrupts the typical over-reliance on the parent and health care provider that often impedes developing independence.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Self-management as measured by the Partners in Health Scale
Time Frame: baseline 3-, 6-, 9-, 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 (range: 0-8; higher scores indicate better self-management), providing total and subscale scores (knowledge, coping, recognition and management of functions, adherence to treatment).
|
baseline 3-, 6-, 9-, 12 months
|
Change in Patient activation as measured by the Patient Activation Measure (PAM-13)
Time Frame: baseline 3-, 6-, 9-, 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 and is scored on a 5-point Likert scale (range: 0-100 with higher scores indicating higher patient activation in self-management).
|
baseline 3-, 6-, 9-, 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Transition Readiness as measured by the Transition Readiness Questionnaire (TRAQ 20)
Time Frame: baseline 3-, 6-, 9-, 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.
The TRAQ scores produced include an overall score and a subscale score for each of the five subscales.
The overall score and the subscale scores are calculated by taking the average score across the items in the questionnaire (or subscale).
Each item is scored 1-5.
Higher scores indicate more transition readiness
|
baseline 3-, 6-, 9-, 12 months
|
Change in Health-related Quality of Life as measured by the Short Form Health Survey (SF12)
Time Frame: baseline 3-, 6-, 9-, 12 months
|
Health-related Quality of Life variable measured using the Short Form Health Survey (SF12): 12-item self-report that assesses physical and mental health related quality of life.
Results are expressed in terms of two meta-scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).
The PCS and MCS scores have a range of 0 to 100 and were designed to have a mean score of 50.
Higher scores indicate better physical functioning.
|
baseline 3-, 6-, 9-, 12 months
|
Change in Emotional Health as measured by the Brief Symptom Inventory (BSI 18)
Time Frame: baseline 3-, 6-, 9-, 12 months
|
Emotional health variable measured using the Brief Symptom Inventory: 18-item self-report of emotional symptoms experienced over the previous 7 days.
Subscales include depression, anxiety, and somatization.
5-point Likert scale, with three sub-scale scores and an overall global psychological distress score.
Higher scores indicate more psychological distress.
|
baseline 3-, 6-, 9-, 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Angel Barnes, BSN, Duke University School of Nursing
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 29, 2019
Primary Completion (Estimated)
May 1, 2024
Study Completion (Estimated)
May 1, 2024
Study Registration Dates
First Submitted
May 2, 2019
First Submitted That Met QC Criteria
May 2, 2019
First Posted (Actual)
May 6, 2019
Study Record Updates
Last Update Posted (Actual)
January 25, 2024
Last Update Submitted That Met QC Criteria
January 24, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Glucose Metabolism Disorders
- Metabolic Diseases
- Respiratory Tract Diseases
- Immune System Diseases
- Autoimmune Diseases
- Lung Diseases
- Urologic Diseases
- Endocrine System Diseases
- Disease Attributes
- Hematologic Diseases
- Gastrointestinal Diseases
- Infant, Newborn, Diseases
- Diabetes Mellitus
- Renal Insufficiency
- Genetic Diseases, Inborn
- Connective Tissue Diseases
- Gastroenteritis
- Intestinal Diseases
- Anemia
- Pancreatic Diseases
- Anemia, Hemolytic, Congenital
- Anemia, Hemolytic
- Hemoglobinopathies
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Kidney Diseases
- Renal Insufficiency, Chronic
- Diabetes Mellitus, Type 1
- Lupus Erythematosus, Systemic
- Inflammatory Bowel Diseases
- Chronic Disease
- Cystic Fibrosis
- Anemia, Sickle Cell
Other Study ID Numbers
- Pro00102191
- 1R01NR018379-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Kidney Diseases
-
3-C Institute for Social DevelopmentUniversity of North Carolina, Chapel HillCompletedChronic Kidney Diseases | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage4 | Pediatric Kidney Disease | Chronic Kidney Disease stage3 | Chronic Kidney Disease Stage V | Chronic Kidney Disease, Stage IV (Severe) | Chronic Kidney Disease Stage 2 | Chronic Kidney Disease, Stage IUnited States
-
American Academy of Family PhysiciansUniversity of Colorado, Denver; National Institute of Diabetes and Digestive... and other collaboratorsCompletedChronic Kidney Disease | Chronic Renal Insufficiency | Chronic Kidney Insufficiency | Chronic Renal Diseases | Kidney Insufficiency, ChronicUnited States
-
Universiti Putra MalaysiaRecruitingChronic Kidney Diseases | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage4 | Chronic Kidney Disease stage3 | Chronic Kidney Disease Requiring Chronic DialysisMalaysia
-
Centre Hospitalier le MansLe Mans UniversiteWithdrawnFatigue | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage3 | Chronic Kidney Failure | Chronic Kidney Disease, Stage 4 (Severe)
-
National Taiwan University HospitalCompletedChronic Kidney Disease stage4 | Chronic Kidney Disease stage3 | Chronic Kidney Disease Stage 2 | Chronic Kidney Disease Stage 1Taiwan
-
Centre Hospitalier le MansLe Mans UniversiteRecruitingFatigue | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage4 | Chronic Kidney Disease Stage 3BFrance
-
University of WashingtonJohns Hopkins University; National Institute of Diabetes and Digestive and... and other collaboratorsRecruitingChronic Kidney Diseases | Acute Renal Failure | Acute Renal Injury | Acute Kidney Failure | Chronic Renal Insufficiency | Kidney Failure, Acute | Renal Insufficiency, Acute | Acute Renal Insufficiency | Acute Kidney Insufficiency | Renal Failure, Acute | Chronic Kidney Insufficiency | Chronic Renal Diseases | Kidney... and other conditionsUnited States
-
University of the State of Santa CatarinaUnknownKidney Diseases | Chronic Kidney Diseases | Hemodialysis | Chronic Renal Insufficiency | Renal Dialysis | Chronic Kidney Insufficiency | Chronic Renal DiseasesBrazil
-
Texas A&M UniversityWithdrawnChronic Kidney FailureUnited States
-
Lund UniversityBaxter Healthcare Corporation; Universidad de CórdobaCompletedEnd Stage Kidney Disease | Chronic Kidney Disease Requiring Chronic DialysisArgentina
Clinical Trials on PiCASO Intervention Group
-
Muğla Sıtkı Koçman UniversityNot yet recruiting
-
University of LiegeCentre Hospitalier Universitaire de Liege; Bial Foundation; FNRS (Télévie); Fondation...RecruitingPain | Cancer | Fatigue | Cognitive Impairment | Sleep Disturbance | Distress, EmotionalBelgium
-
Hospital de Clinicas de Porto AlegreUnknown
-
University of California, San FranciscoNational Cancer Institute (NCI); Cancer Prevention Institute of CaliforniaCompletedHereditary Breast and Ovarian Cancer Syndrome
-
University of Sao PauloCompletedAnxiety | Self Esteem
-
Haute Ecole de Santé VaudCompletedArthroplasty, Replacement, Knee | Arthroplasty, Replacement, HipSwitzerland
-
Azienda Ospedaliero-Universitaria CareggiRecruiting
-
University of North Carolina, Chapel HillNational Heart, Lung, and Blood Institute (NHLBI)CompletedHeart Diseases | Cardiovascular Diseases
-
University of OxfordOxford Brookes UniversityRecruitingOverweight/Obesity, AdolescentUnited Kingdom
-
Beijing Tsinghua Chang Gung HospitalRecruitingLifestyle Intervention | Non Communicable DiseasesChina