Accessible Mobile Health and Wellness

Physical Disability Clinical Trial

— CHAMPs  

Official title:

Accessible Mobile Health and Wellness

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03768401
• Other study ID #: 17-008524
• Status: Terminated
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: December 21, 2018

Study information

• Verified date: April 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: December 21, 2018
• Est. primary completion date: December 21, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Neurologic Dysfunction
• Neurologic Manifestations
• Physical Disability

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Kristin Zhao, PhD	Southeastern Minnesota Center for Independent Living

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Efficacy of wellness clinics	Efficacy of wellness clinics, as determined by repeated t-tests	3 months post end of wellness clinics

External Links

•   Mayo Clinic Clinical Trials