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Peer Coaching for Chronic Disease (PiCASO Trial)

N/A
Waitlist Available
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
AYA 16 to 22 years
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline 3-, 6-, 9-, 12 months
Awards & highlights

PiCASO Trial Summary

This trial will test if a peer support coaching intervention can help improve self-management of chronic illness in adolescents and young adults.

Who is the study for?
This trial is for English-speaking adolescents and young adults aged 16 to 22 with certain chronic conditions like cystic fibrosis, kidney disease, or type 1 diabetes. Participants need internet access and a phone. Those needing an English translator or diagnosed with cognitive dysfunction cannot join.Check my eligibility
What is being tested?
The study tests a peer support coaching program (PiCASO Intervention) aimed at improving self-management of chronic illnesses in youth versus an attention control group that does not receive this intervention.See study design
What are the potential side effects?
Since the intervention involves peer coaching rather than medication, traditional side effects are not expected; however, participants may experience emotional or psychological impacts from the interactions.

PiCASO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 16 and 22 years old.

PiCASO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline 3-, 6-, 9-, 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline 3-, 6-, 9-, 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Patient activation as measured by the Patient Activation Measure (PAM-13)
Change in Self-management as measured by the Partners in Health Scale
Secondary outcome measures
Change in Emotional Health as measured by the Brief Symptom Inventory (BSI 18)
Change in Health-related Quality of Life as measured by the Short Form Health Survey (SF12)
Change in Transition Readiness as measured by the Transition Readiness Questionnaire (TRAQ 20)

PiCASO Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: PiCASO Intervention GroupExperimental Treatment1 Intervention
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.
Group II: Attention Control GroupPlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,356 Previous Clinical Trials
3,418,904 Total Patients Enrolled
2 Trials studying Cystic Fibrosis
30,024 Patients Enrolled for Cystic Fibrosis
National Institutes of Health (NIH)NIH
2,687 Previous Clinical Trials
6,930,700 Total Patients Enrolled
10 Trials studying Cystic Fibrosis
1,077 Patients Enrolled for Cystic Fibrosis
National Institute of Nursing Research (NINR)NIH
577 Previous Clinical Trials
10,375,585 Total Patients Enrolled
2 Trials studying Cystic Fibrosis
170 Patients Enrolled for Cystic Fibrosis

Media Library

PiCASO Intervention Group Clinical Trial Eligibility Overview. Trial Name: NCT03938324 — N/A
Cystic Fibrosis Research Study Groups: Attention Control Group, PiCASO Intervention Group
Cystic Fibrosis Clinical Trial 2023: PiCASO Intervention Group Highlights & Side Effects. Trial Name: NCT03938324 — N/A
PiCASO Intervention Group 2023 Treatment Timeline for Medical Study. Trial Name: NCT03938324 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the protocol for this study allow individuals under 45 to participate?

"This clinical research trial has established the age range of 16 to 22 as its inclusion criteria. On a broader scale, there are 603 trials for minors and 1267 studies available for seniors."

Answered by AI

Is there an age or medical condition required to participate in this research?

"This phase 3 trial is seeking 225 participants with asthma, aged between 16 and 22. For inclusion in the study, candidates must meet a few requisites: they need to be an adolescent or young adult (AYA) between 16-22 years old; have access to both internet and telephone (smartphone not necessary); possess a history of childhood onset chronic condition from one of three categories outlined by the research team."

Answered by AI

Is this research opportunity available to participants at the moment?

"Clinicaltrials.gov indicates that recruitment for this medical trial is still ongoing, with the original posting being made on October 29th 2019 and a recent update to information taking place on June 29th 2022."

Answered by AI

How wide is the enrollment for this research initiative?

"Affirmative. The trial, posted in October 2019 and amended in June 2022, is currently looking for 225 applicants to join the experiment at one specific medical centre as per information available on clinicaltrials.gov."

Answered by AI
~0 spots leftby May 2024