- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03170167
Communitas: A Program for Teens Living With Chronic Illness and Their Families
March 1, 2019 updated by: Rick Hecht, University of California, San Francisco
Effectiveness of a Mind-Body and Peer Support Program for Teens Living With Chronic Illness and Their Parents: A Pilot Study
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.
Study Overview
Status
Unknown
Conditions
Detailed 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.
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Brittany Blockman, MD
- Phone Number: 9176879759
- Email: brittany.blockman@ucsf.edu
Study Locations
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California
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San Francisco, California, United States, 94115
- Recruiting
- Osher Center for Integrative Medicine
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Contact:
- Brittany Blockman, MD
- Phone Number: 917-687-9759
- Email: brittany.blockman@gmail.com
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 20 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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).
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical wellbeing
Time Frame: Change from baseline NIH Promis Global Health instrument summary score at 2 months and at 5 months
|
NIH Promis Global Health instrument summary score
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Change from baseline NIH Promis Global Health instrument summary score at 2 months and at 5 months
|
Mental wellbeing
Time Frame: Change from baseline NIH Promis Global Health instrument summary score at 2 months and at 5 months
|
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
Time Frame: Change from baseline Perceived stress scale summary score at 2 months, and at 5 months
|
Perceived stress scale summary score
|
Change from baseline Perceived stress scale summary score at 2 months, and at 5 months
|
Mood: Tension
Time Frame: Change from baseline Profile of Mood States Tension instrument subscale score at 2 months and at 5 months
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Profile of Mood States Tension instrument subscale score
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Change from baseline Profile of Mood States Tension instrument subscale score at 2 months and at 5 months
|
Resilience
Time Frame: Change from baseline 14-Item Resilience Scale summary score at 2 months and at 5 months
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14-Item Resilience Scale summary score
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Change from baseline 14-Item Resilience Scale summary score at 2 months and at 5 months
|
Social support
Time Frame: Change from baseline Social Support Scale summary score at 2 months, and at 5 months
|
Social Support Scale summary score
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Change from baseline Social Support Scale summary score at 2 months, and at 5 months
|
Mindfulness
Time Frame: Change from baseline Mindful Attention Awareness Scale summary score at 2 months, and at 5 months
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Mindful Attention Awareness Scale summary score
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Change from baseline Mindful Attention Awareness Scale summary score at 2 months, and at 5 months
|
Mood: Anger
Time Frame: Change from baseline Profile of Mood States Anger instrument sub scale score at 2 months, and at 5 months
|
Profile of Mood States Anger instrument subscale score
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Change from baseline Profile of Mood States Anger instrument sub scale score at 2 months, and at 5 months
|
Mood: Depression
Time Frame: Change from baseline Profile of Mood States Depression instrument sub scale score at 2 months, and at 5 months
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Profile of Mood States Depression instrument subscale score
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Change from baseline Profile of Mood States Depression instrument sub scale score at 2 months, and at 5 months
|
Mood: Fatigue
Time Frame: Change from baseline Profile of Mood States Fatigue instrument sub scale score at 2 months, and at 5 months
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Profile of Mood States Fatigue instrument subscale score
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Change from baseline Profile of Mood States Fatigue instrument sub scale score at 2 months, and at 5 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-reported adherence, using Medical Outcomes Study General Adherence scale
Time Frame: Change from baseline Medical Outcomes Study General Adherence instrument summary score at 2 months, and at 5 months
|
Medical Outcomes Study General Adherence instrument summary score
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Change from baseline Medical Outcomes Study General Adherence instrument summary score at 2 months, and at 5 months
|
pain medicine usage in past month
Time Frame: Change from baseline pain medicine usage in past month likert scale at 2 months, and at 5 months
|
likert scale
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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
Time Frame: Change from baseline number visits to emergency department in past month at 2 months, and at 5 months
|
Change from baseline number visits to emergency department in past month at 2 months, and at 5 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Frederick M Hecht, MD, UCSF Osher Center for Integrative Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2016
Primary Completion (Anticipated)
June 30, 2020
Study Completion (Anticipated)
June 30, 2020
Study Registration Dates
First Submitted
October 18, 2016
First Submitted That Met QC Criteria
May 25, 2017
First Posted (Actual)
May 30, 2017
Study Record Updates
Last Update Posted (Actual)
March 4, 2019
Last Update Submitted That Met QC Criteria
March 1, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-11679
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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