Communitas: A Program for Teens Living With Chronic Illness and Their Families

Chronic Illness Clinical Trial

Official title:

Effectiveness of a Mind-Body and Peer Support Program for Teens Living With Chronic Illness and Their Parents: A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03170167
• Other study ID #: 13-11679
• Status: Recruiting
• Start date: October 2016
• Est. completion date: June 30, 2020

Study information

• Verified date: March 2019
• Source: University of California, San Francisco
• Contact: Brittany Blockman, MD
• Phone: 9176879759
• Email: brittany.blockman[@]ucsf.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The proposed pilot study is an evaluation of Communitas, a mind-body skills group visit and for 12-19 year-olds living with chronic physical illness. The goal of this study is to assess the efficacy and feasibility of these group visits. During 2017-2018, the investigators will recruit 50-100 patient and 50-100 parent enrollees of Communitas to participate in this study. The study will be a pre-post evaluation, without a control group, using validated patient-report assessments at baseline, after completion of the group visits, and 3 months later. The primary outcome variables will be physical and mental wellbeing, stress, mood, resilience, mindfulness, and social support. Paired t tests will be used to assess changes from baseline to immediately post-intervention & 3 months post-intervention. The investigators will also calculate Cohen's d effect sizes, to help them understand the degree to which an effect is present in the population.

Description:

The Communitas pilot study is a survey study of Communitas, a pre-existing integrative medicine and mind-body skills group visit for adolescents living with chronic illness and their parents. The goal of this study is to evaluate the preliminary efficacy and feasibility for these group visits. Approximately 50-100 patients and 50-100 parent enrollees of the Communitas group visits will be recruited to participate in this survey study optionally. During the group visits, both the patient and parent groups will learn about and experience various coping, self-care, pain and stress-reduction modalities, participate in group sharing to promote engagement with a diagnosis and provide emotional support, and benefit from facilitated discussions about some of the more practical aspects of living with chronic illness. The group visits will be offered to patients and their parents as clinical service, regardless of enrollment in the survey study, and will be billed to insurance as consult group visit with the pediatrician. The group visits will be held at both the Osher Center for Integrative Medicine and Mission Bay Children's Hospital and will be led by a pediatrician, starting in October 2016. The study will be set up as a pre-post evaluation, without a control group, using patient-report and parent-report qualitative and quantitative assessments at baseline, after completion of the series of group visits, and 3 months later. In addition, some families may be asked if they would like to participate in a videotaped interview before and after the start of the program.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 20 Years

Eligibility

Inclusion Criteria:

• Enrolled in the Communitas group visit at the UCSF Osher Center for Integrative Medicine or Mission Bay Children's Hospital.

• Patients enrolled in these group visits are males and females 12-20 years of age and living with a chronic illness.

Exclusion Criteria:

• People who are not enrolled in the Communitas group visit at the UCSF Osher Center for Integrative Medicine or Mission Bay Children's Hospital will be excluded from this survey study.

• The Communitas group consists of a patient group of young people ages 12-20 living with chronic illness, as well as a parent group.

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Illness

Locations

Country	Name	City	State
United States	Osher Center for Integrative Medicine	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical wellbeing	NIH Promis Global Health instrument summary score	Change from baseline NIH Promis Global Health instrument summary score at 2 months and at 5 months
Primary	Mental wellbeing	NIH Promis Global Health instrument summary score	Change from baseline NIH Promis Global Health instrument summary score at 2 months and at 5 months
Primary	Perceived Stress	Perceived stress scale summary score	Change from baseline Perceived stress scale summary score at 2 months, and at 5 months
Primary	Mood: Tension	Profile of Mood States Tension instrument subscale score	Change from baseline Profile of Mood States Tension instrument subscale score at 2 months and at 5 months
Primary	Resilience	14-Item Resilience Scale summary score	Change from baseline 14-Item Resilience Scale summary score at 2 months and at 5 months
Primary	Social support	Social Support Scale summary score	Change from baseline Social Support Scale summary score at 2 months, and at 5 months
Primary	Mindfulness	Mindful Attention Awareness Scale summary score	Change from baseline Mindful Attention Awareness Scale summary score at 2 months, and at 5 months
Primary	Mood: Anger	Profile of Mood States Anger instrument subscale score	Change from baseline Profile of Mood States Anger instrument sub scale score at 2 months, and at 5 months
Primary	Mood: Depression	Profile of Mood States Depression instrument subscale score	Change from baseline Profile of Mood States Depression instrument sub scale score at 2 months, and at 5 months
Primary	Mood: Fatigue	Profile of Mood States Fatigue instrument subscale score	Change from baseline Profile of Mood States Fatigue instrument sub scale score at 2 months, and at 5 months
Secondary	Self-reported adherence, using Medical Outcomes Study General Adherence scale	Medical Outcomes Study General Adherence instrument summary score	Change from baseline Medical Outcomes Study General Adherence instrument summary score at 2 months, and at 5 months
Secondary	pain medicine usage in past month	likert scale	Change from baseline pain medicine usage in past month likert scale at 2 months, and at 5 months
Secondary	number visits to emergency department in past month		Change from baseline number visits to emergency department in past month at 2 months, and at 5 months