Peers for Promoting Adolescent Transplant Health (Peers4PATH)
|ClinicalTrials.gov Identifier: NCT01450033|
Recruitment Status : Completed
First Posted : October 12, 2011
Last Update Posted : May 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Behavior and Behavior Mechanisms||Behavioral: Peer Mentoring Behavioral: e-Communication with mentor||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||A Peer Mentoring Intervention to Improve Adherence and Quality of Life in Adolescents With Solid Organ Transplants|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||January 2017|
|Actual Study Completion Date :||March 29, 2017|
No Intervention: Control group
Standard of care
Experimental: Mentoring group
Subjects in this group will participate in the following intervention activities: medical record review; questionnaires including the Hollingshead Socioeconomic Status Survey, modified Medication Adherence Module, Peds QL Transplant Module, Medical Outcomes Study Social Support Scale, and self-efficacy scale; in-person meetings with mentor; e-communication with mentor (i.e. texts, Facebook, phone calls, etc); and collection of pharmacy refill data and clinical data.
Behavioral: Peer Mentoring
Subjects will be assigned a peer mentor who will provide social support primarily via e-communication. They will also meet in-person at study entry, 6 months and 1-year.
Behavioral: e-Communication with mentor
Subjects will interact on a mutually agreeable basis via their choice of text messaging, Facebook, phone calls, emails, and other formats
- Medication adherence [ Time Frame: 1 year ]The primary endpoint is medication adherence, defined by the modified Medication Adherence Module (MAM), standard deviations of immunosuppressive drug levels, percent adherence from pharmacy refill data and pill counts at 1 year.
- Mentoring mechanisms [ Time Frame: 1 year ]The secondary endpoint is to determine the mechanisms through which peer mentoring impacts medication adherence and healthcare-related quality of life. It is hypothesized that peer mentors will provide social support which will improve subject self-efficacy.
- Quality of Life [ Time Frame: 1 year ]Health-related Quality of Life (QL) will be measured using the Peds QL Transplant Module.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01450033
|United States, Pennsylvania|
|The Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Sandra Amaral, MD, MHS||Children's Hospital of Philadelphia|