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

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ClinicalTrials.gov Identifier: NCT03170167
Recruitment Status : Recruiting
First Posted : May 30, 2017
Last Update Posted : March 4, 2019
Sponsor:
Information provided by (Responsible Party):
Rick Hecht, University of California, San Francisco

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.

Condition or disease
Chronic Illness

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Effectiveness of a Mind-Body and Peer Support Program for Teens Living With Chronic Illness and Their Parents: A Pilot Study
Actual Study Start Date : October 2016
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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

  2. 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

  3. Perceived Stress [ Time Frame: Change from baseline Perceived stress scale summary score at 2 months, and at 5 months ]
    Perceived stress scale summary score

  4. Mood: Tension [ Time Frame: Change from baseline Profile of Mood States Tension instrument subscale score at 2 months and at 5 months ]
    Profile of Mood States Tension instrument subscale score

  5. Resilience [ Time Frame: Change from baseline 14-Item Resilience Scale summary score at 2 months and at 5 months ]
    14-Item Resilience Scale summary score

  6. Social support [ Time Frame: Change from baseline Social Support Scale summary score at 2 months, and at 5 months ]
    Social Support Scale summary score

  7. Mindfulness [ Time Frame: Change from baseline Mindful Attention Awareness Scale summary score at 2 months, and at 5 months ]
    Mindful Attention Awareness Scale summary score

  8. 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

  9. Mood: Depression [ Time Frame: Change from baseline Profile of Mood States Depression instrument sub scale score at 2 months, and at 5 months ]
    Profile of Mood States Depression instrument subscale score

  10. Mood: Fatigue [ Time Frame: Change from baseline Profile of Mood States Fatigue instrument sub scale score at 2 months, and at 5 months ]
    Profile of Mood States Fatigue instrument subscale score


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03170167


Contacts
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Contact: Brittany Blockman, MD 9176879759 brittany.blockman@ucsf.edu

Locations
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United States, California
Osher Center for Integrative Medicine Recruiting
San Francisco, California, United States, 94115
Contact: Brittany Blockman, MD    917-687-9759    brittany.blockman@gmail.com   
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Frederick M Hecht, MD UCSF Osher Center for Integrative Medicine

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Responsible Party: Rick Hecht, Research Director of the Osher Center, and Professor of Medicine at UCSF, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03170167    
Other Study ID Numbers: 13-11679
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Chronic Disease
Disease Attributes
Pathologic Processes