Back to resultsAccessible Mobile Health and Wellness (CHAMPs)
Primary Purpose
Physical Disability, Neurologic Dysfunction
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Education
Trial Exercise Modalities
Sponsored by
About this trial
This is an interventional health services research trial for Physical Disability
Eligibility Criteria
Inclusion Criteria:
- [for community participants/caregivers/family members] Ability to demonstrate clear communication and understanding of English.
- [for participants with neurological physical conditions] Neurological physical conditions including cerebral palsy, spinal cord injury, stroke, multiple sclerosis, or similar diagnoses
- [for educational seminars] > 6 years of age.
- [for wellness/exercise clinic] 18 65 years of age
- [for wellness/exercise clinic; participants with neurological physical conditions] Clearance by primary care or treating physician
Exclusion Criteria:
- [for participants with neurological physical conditions] Unstable fractures
- [for participants with neurological physical conditions] Uncontrolled hypertension (combined systolic/diastolic > 140/90 mmHg)
- [for participants with neurological physical conditions] Enrollment of individual deemed by study staff to be unsafe
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Educational Seminars and Wellness Clinics
Arm Description
I. Community outreach educational seminars about wellness and exercise while living with a neurological physical disability and measurement of the effects of these seminars for training individuals with neurological physical disabilities and their care givers (family, therapists, community personal trainers and community funders such as Lions or Rotary Clubs) about how to create a safe cost-effective exercise program . II. Creation and measurement of the effects of a wellness clinic for those with a neurological physical disability.
Outcomes
Primary Outcome Measures
Incidence of new self-sustaining wellness and exercise programs
Incidence of new self-sustaining wellness and exercise programs, as determined by Follow-up Site Staff Survey
Secondary Outcome Measures
Efficacy of seminars for individuals with a neurological physical disability
Efficacy of seminars, as determined by repeated t-tests based on the Exercise Self-Efficacy Survey (ESES), a 10-question survey with scores of 1 to 4 (with 4 being the best outcome), summed for a minimum score of 10, and a maximum score of 40.
Efficacy of seminars for caregivers and clinic staff of patients with neurological physical disabilities
Efficacy of seminars, as determined by repeated t-tests based on the Exercise Efficacy for Caregivers and Staff, a 10-question survey with scores of 1 to 4 (with 4 being the best outcome), summed for a minimum score of 10, and a maximum score of 40.
Efficacy of wellness clinics
Efficacy of wellness clinics, as determined by repeated t-tests
Full Information
NCT ID
NCT03768401
First Posted
July 17, 2018
Last Updated
April 28, 2019
Sponsor
Kristin Zhao, PhD
Collaborators
Southeastern Minnesota Center for Independent Living
1. Study Identification
Unique Protocol Identification Number
NCT03768401
Brief Title
Accessible Mobile Health and Wellness
Acronym
CHAMPs
Official Title
Accessible Mobile Health and Wellness
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
Funding/grant expired.
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
December 21, 2018 (Actual)
Study Completion Date
December 21, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kristin Zhao, PhD
Collaborators
Southeastern Minnesota Center for Independent Living
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Can community outreach education help develop self-sustaining wellness and exercise programs, and will associated wellness clinics help persons with a neurological physical disability achieve better well-being?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Disability, Neurologic Dysfunction
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Educational Seminars and Wellness Clinics
Arm Type
Experimental
Arm Description
I. Community outreach educational seminars about wellness and exercise while living with a neurological physical disability and measurement of the effects of these seminars for training individuals with neurological physical disabilities and their care givers (family, therapists, community personal trainers and community funders such as Lions or Rotary Clubs) about how to create a safe cost-effective exercise program .
II. Creation and measurement of the effects of a wellness clinic for those with a neurological physical disability.
Intervention Type
Other
Intervention Name(s)
Education
Intervention Description
Seminars about wellness and exercise, and resulting therapeutic programs, while living with a neurological physical disability.
Intervention Type
Behavioral
Intervention Name(s)
Trial Exercise Modalities
Intervention Description
Wellness/exercise clinics located at Mayo Clinic, Rochester will be offered to persons with neurological physical disabilities on a regular basis, at least monthly, during the last half of the trial period.
Primary Outcome Measure Information:
Title
Incidence of new self-sustaining wellness and exercise programs
Description
Incidence of new self-sustaining wellness and exercise programs, as determined by Follow-up Site Staff Survey
Time Frame
3 months post end of wellness clinics
Secondary Outcome Measure Information:
Title
Efficacy of seminars for individuals with a neurological physical disability
Description
Efficacy of seminars, as determined by repeated t-tests based on the Exercise Self-Efficacy Survey (ESES), a 10-question survey with scores of 1 to 4 (with 4 being the best outcome), summed for a minimum score of 10, and a maximum score of 40.
Time Frame
3 months post end of wellness clinics
Title
Efficacy of seminars for caregivers and clinic staff of patients with neurological physical disabilities
Description
Efficacy of seminars, as determined by repeated t-tests based on the Exercise Efficacy for Caregivers and Staff, a 10-question survey with scores of 1 to 4 (with 4 being the best outcome), summed for a minimum score of 10, and a maximum score of 40.
Time Frame
3 months post end of wellness clinics
Title
Efficacy of wellness clinics
Description
Efficacy of wellness clinics, as determined by repeated t-tests
Time Frame
3 months post end of wellness clinics
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
[for community participants/caregivers/family members] Ability to demonstrate clear communication and understanding of English.
[for participants with neurological physical conditions] Neurological physical conditions including cerebral palsy, spinal cord injury, stroke, multiple sclerosis, or similar diagnoses
[for educational seminars] > 6 years of age.
[for wellness/exercise clinic] 18 65 years of age
[for wellness/exercise clinic; participants with neurological physical conditions] Clearance by primary care or treating physician
Exclusion Criteria:
[for participants with neurological physical conditions] Unstable fractures
[for participants with neurological physical conditions] Uncontrolled hypertension (combined systolic/diastolic > 140/90 mmHg)
[for participants with neurological physical conditions] Enrollment of individual deemed by study staff to be unsafe
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin D Zhao
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Accessible Mobile Health and Wellness
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