A Health Action Process Approach Online Intervention for People With Multiple Sclerosis (eHAPA-MS)
Primary Purpose
Multiple Sclerosis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MSPA eClass
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Physical Activity, Internet-Based Intervention
Eligibility Criteria
Inclusion Criteria:
- are 18 years old and above;
- have not maintained 30 minutes of MVPA accumulated per day for 2 days of the week during the previous 6 months;
- have a score < 24 for the leisure score index of the Godin Leisure-Time Exercise Questionnaire;
- be relapse-free for the past 30 days;
- show low risk for contraindications of PA indicated by no more than a single 'yes' response on the Physical Activity Readiness Questionnaire;
- be able to walk with or without an assistive device;
- are willing to be randomized to an intervention or control group, complete the surveys and questionnaires, and wear an accelerometer during the intervention period;
- have Internet access.
Exclusion Criteria:
-
Sites / Locations
- University of Illinois Urbana-ChampaignRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
MSPA eClass
Waiting list
Arm Description
Outcomes
Primary Outcome Measures
The Health Action Process Approach Battery
The battery measures risk perception, exercise benefits, motivation, and volition.
"change" is being assessed.
Secondary Outcome Measures
Full Information
NCT ID
NCT05124522
First Posted
October 25, 2021
Last Updated
May 8, 2023
Sponsor
University of Illinois at Urbana-Champaign
1. Study Identification
Unique Protocol Identification Number
NCT05124522
Brief Title
A Health Action Process Approach Online Intervention for People With Multiple Sclerosis
Acronym
eHAPA-MS
Official Title
Developing A Person-centered Internet-based Health Action Process Approach to Promoting Physical Activity in People With Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 25, 2021 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Urbana-Champaign
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study is to implement the person-centered internet-based Health Action Process Approach to promoting physical activity in people with Multiple Sclerosis (i.e., eHAPA-MS online intervention) and assess the intervention's effectiveness and adherence.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Physical Activity, Internet-Based Intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MSPA eClass
Arm Type
Experimental
Arm Title
Waiting list
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
MSPA eClass
Intervention Description
An 8-week MS-HAPA Internet-based intervention
Primary Outcome Measure Information:
Title
The Health Action Process Approach Battery
Description
The battery measures risk perception, exercise benefits, motivation, and volition.
"change" is being assessed.
Time Frame
Through study completion, an average of 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
are 18 years old and above;
have not maintained 30 minutes of MVPA accumulated per day for 2 days of the week during the previous 6 months;
have a score < 24 for the leisure score index of the Godin Leisure-Time Exercise Questionnaire;
be relapse-free for the past 30 days;
show low risk for contraindications of PA indicated by no more than a single 'yes' response on the Physical Activity Readiness Questionnaire;
be able to walk with or without an assistive device;
are willing to be randomized to an intervention or control group, complete the surveys and questionnaires, and wear an accelerometer during the intervention period;
have Internet access.
Exclusion Criteria:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chungyi Chiu, PhD
Phone
217-244-6435
Email
chiucy@illinois.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chungyi Chiu, PhD
Organizational Affiliation
University of Illinois Urbana-Champaign
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois Urbana-Champaign
City
Champaign
State/Province
Illinois
ZIP/Postal Code
61820
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chungyi Chiu
Phone
217-244-6435
Email
chiucy@illinois.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The intervention result report.
IPD Sharing Time Frame
Anticipated December 2023
Learn more about this trial
A Health Action Process Approach Online Intervention for People With Multiple Sclerosis
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