Evidence Based Patient Information and Smartphone Accelerometry to Enhance Physical Activity in MS (PIA)
Primary Purpose
Multiple Sclerosis, Chronic Progressive
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Smartphone App
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis, Chronic Progressive focused on measuring Physical activity, Mobility
Eligibility Criteria
Inclusion Criteria:
- progressive MS
Exclusion Criteria:
- other major health disorder
- EDSS above 6
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Waiting group
Smartphone intervention
Arm Description
Waiting group
Smartphone bases behavioural intervention
Outcomes
Primary Outcome Measures
Rate of responders
Rate of responders as defined by a 20% increase of steps or 20% increase in physical activity as measured with the actigraph
Secondary Outcome Measures
Physical activity: total activity
Physical activity and real-life mobility: 1-week accelerometry (actigraph)
Physical activity: distance per day
Physical activity and real-life mobility: 1-week accelerometry (actigraph)
Physical activity: number of steps per day
Physical activity and real-life mobility: 1-week accelerometry (actigraph)
Questionnaires on quality of life (QoL, HAQUAMS)
Disease specific quality of life questionnaire
Questionnaires on activities of daily living (ADL)
Frenchay activity index
Questionnaires on physical activity
Godin Leisure time
Full Information
NCT ID
NCT03114293
First Posted
March 31, 2017
Last Updated
May 2, 2017
Sponsor
Universitätsklinikum Hamburg-Eppendorf
1. Study Identification
Unique Protocol Identification Number
NCT03114293
Brief Title
Evidence Based Patient Information and Smartphone Accelerometry to Enhance Physical Activity in MS
Acronym
PIA
Official Title
Evidence Based Patient Information and Smartphone Accelerometry to Enhance Physical Activity in MS
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2016 (Actual)
Primary Completion Date
May 30, 2017 (Anticipated)
Study Completion Date
May 30, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf
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
Due to their ubiquitary distribution, smartphones might serve as an easy way/ possibility to use feedback mechanism in an app-based intervention program to increase physical activity in Multiple Sclerosis (MS) patients. Internet based cognitive-behavioral interventions have been explored as effective in the last years. In addition, smartphone-based mobility assessment and intervention might be a promising approach in other MS types and for real-life mobility assessment in observational and interventional trials. The aim is to investigate the impact of a smartphone based information and feedback program on physical activity in a 3 months, randomised waiting-group controlled trial of 40 progressive MS patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Chronic Progressive
Keywords
Physical activity, Mobility
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Short, randomised waiting-group controlled explorative studies of a behavioural intervention.
Masking
InvestigatorOutcomes Assessor
Masking Description
Rater blinded.
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Waiting group
Arm Type
No Intervention
Arm Description
Waiting group
Arm Title
Smartphone intervention
Arm Type
Experimental
Arm Description
Smartphone bases behavioural intervention
Intervention Type
Behavioral
Intervention Name(s)
Smartphone App
Intervention Description
The app includes an EBPI and physical activity feedback
Primary Outcome Measure Information:
Title
Rate of responders
Description
Rate of responders as defined by a 20% increase of steps or 20% increase in physical activity as measured with the actigraph
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Physical activity: total activity
Description
Physical activity and real-life mobility: 1-week accelerometry (actigraph)
Time Frame
3 Months
Title
Physical activity: distance per day
Description
Physical activity and real-life mobility: 1-week accelerometry (actigraph)
Time Frame
3 Months
Title
Physical activity: number of steps per day
Description
Physical activity and real-life mobility: 1-week accelerometry (actigraph)
Time Frame
3 Months
Title
Questionnaires on quality of life (QoL, HAQUAMS)
Description
Disease specific quality of life questionnaire
Time Frame
3 Months
Title
Questionnaires on activities of daily living (ADL)
Description
Frenchay activity index
Time Frame
3 Months
Title
Questionnaires on physical activity
Description
Godin Leisure time
Time Frame
3 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
progressive MS
Exclusion Criteria:
other major health disorder
EDSS above 6
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Evidence Based Patient Information and Smartphone Accelerometry to Enhance Physical Activity in MS
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