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Accessible Mobile Health and Wellness (CHAMPs)

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ClinicalTrials.gov Identifier: NCT03768401
Recruitment Status : Terminated (Funding/grant expired.)
First Posted : December 7, 2018
Last Update Posted : April 30, 2019
Sponsor:
Collaborator:
Southeastern Minnesota Center for Independent Living
Information provided by (Responsible Party):
Kristin Zhao, PhD, Mayo Clinic

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?

Condition or disease Intervention/treatment Phase
Physical Disability Neurologic Dysfunction Other: Education Behavioral: Trial Exercise Modalities Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Accessible Mobile Health and Wellness
Actual Study Start Date : August 1, 2018
Actual Primary Completion Date : December 21, 2018
Actual Study Completion Date : December 21, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Educational Seminars and Wellness Clinics

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.

Other: Education
Seminars about wellness and exercise, and resulting therapeutic programs, while living with a neurological physical disability.

Behavioral: Trial Exercise Modalities
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 Measures :
  1. Incidence of new self-sustaining wellness and exercise programs [ Time Frame: 3 months post end of wellness clinics ]
    Incidence of new self-sustaining wellness and exercise programs, as determined by Follow-up Site Staff Survey


Secondary Outcome Measures :
  1. Efficacy of seminars for individuals with a neurological physical disability [ Time Frame: 3 months post end of wellness clinics ]
    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.

  2. Efficacy of seminars for caregivers and clinic staff of patients with neurological physical disabilities [ Time Frame: 3 months post end of wellness clinics ]
    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.

  3. Efficacy of wellness clinics [ Time Frame: 3 months post end of wellness clinics ]
    Efficacy of wellness clinics, as determined by repeated t-tests



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Ages Eligible for Study:   6 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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): NCT03768401


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Kristin Zhao, PhD
Southeastern Minnesota Center for Independent Living
Investigators
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Principal Investigator: Kristin D Zhao Mayo Clinic

Additional Information:
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Responsible Party: Kristin Zhao, PhD, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03768401     History of Changes
Other Study ID Numbers: 17-008524
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms