Accessible Mobile Health and Wellness (CHAMPs)

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?

Study Overview

• Status: Terminated
• Conditions: Physical Disability; Neurologic Dysfunction
• Intervention / Treatment: Other: Education; Behavioral: Trial Exercise Modalities

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months post end of wellness clinics

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months post end of wellness clinics
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.	3 months post end of wellness clinics
Efficacy of wellness clinics	Efficacy of wellness clinics, as determined by repeated t-tests	3 months post end of wellness clinics

Collaborators and Investigators

• Sponsor: Kristin Zhao, PhD
• Collaborators: Southeastern Minnesota Center for Independent Living
• Investigators: Principal Investigator: Kristin D Zhao, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): December 21, 2018
• Study Completion (Actual): December 21, 2018

Study Registration Dates

• First Submitted: July 17, 2018
• First Submitted That Met QC Criteria: December 5, 2018
• First Posted (Actual): December 7, 2018

Study Record Updates

• Last Update Posted (Actual): April 30, 2019
• Last Update Submitted That Met QC Criteria: April 28, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations
• Other Study ID Numbers: 17-008524

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No