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

NCT03170167 | Unknown

• 1 other identifier: 13-11679
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Illness

Outcome Measures

Primary Outcomes (10)

• 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

• 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

• Perceived Stress

  Perceived stress scale summary score

  Change from baseline Perceived stress scale summary score at 2 months, and at 5 months

• 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

• Resilience

  14-Item Resilience Scale summary score

  Change from baseline 14-Item Resilience Scale summary score at 2 months and at 5 months

• Social support

  Social Support Scale summary score

  Change from baseline Social Support Scale summary score at 2 months, and at 5 months

• Mindfulness

  Mindful Attention Awareness Scale summary score

  Change from baseline Mindful Attention Awareness Scale summary score at 2 months, and at 5 months

• 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

• 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

• 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 Outcomes (3)

• Self-reported adherence, using Medical Outcomes Study General Adherence scale

  Change from baseline Medical Outcomes Study General Adherence instrument summary score at 2 months, and at 5 months

• pain medicine usage in past month

  Change from baseline pain medicine usage in past month likert scale at 2 months, and at 5 months

• 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

Study Arms (2)

Patients

This is a pre-post survey study of Communitas, a pre-existing integrative medicine and mind-body skills group visit for adolescents living with chronic illness and their parents. Approximately 50-100 patient enrollees of the Communitas group visits will be recruited to participate in this survey study optionally.

Parents

This is a pre-post survey study of Communitas, a pre-existing integrative medicine and mind-body skills group visit for adolescents living with chronic illness and their parents. Approximately 50-100 parent enrollees of the Communitas group visits will be recruited to participate in this survey study optionally.

Eligibility Criteria

• Age: 12 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

12-20 year-old pediatric patients who are living with a chronic physical illness and who are enrolled in the Communitas group visit at the UCSF Osher Center for Integrative Medicine or Mission Bay Children's Hospital, along with their willing and available guardian(s).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

Osher Center for Integrative Medicine

San Francisco, California, 94115, United States

RECRUITING

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Frederick M Hecht, MD

  UCSF Osher Center for Integrative Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brittany Blockman, MD

CONTACT

9176879759; brittany.blockman@ucsf.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director of the Osher Center, and Professor of Medicine at UCSF

Study Record Dates

• First Submitted: October 18, 2016
• First Posted: May 30, 2017
• Study Start: October 1, 2016
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: March 4, 2019

Record last verified: 2019-03

Locations

US (1)