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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03170167
Other study ID # 13-11679
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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