Evidence Based Patient Information and Smartphone Accelerometry to Enhance Physical Activity in MS (PIA)
May 2, 2017 updated by: Jan-Patrick Stellmann, Universitätsklinikum Hamburg-Eppendorf
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- progressive MS
Exclusion Criteria:
- other major health disorder
- EDSS above 6
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Waiting group
|
|
|
Experimental: Smartphone intervention
Smartphone bases behavioural intervention
|
The app includes an EBPI and physical activity feedback
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of responders
Time Frame: 3 Months
|
Rate of responders as defined by a 20% increase of steps or 20% increase in physical activity as measured with the actigraph
|
3 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical activity: total activity
Time Frame: 3 Months
|
Physical activity and real-life mobility: 1-week accelerometry (actigraph)
|
3 Months
|
|
Physical activity: distance per day
Time Frame: 3 Months
|
Physical activity and real-life mobility: 1-week accelerometry (actigraph)
|
3 Months
|
|
Physical activity: number of steps per day
Time Frame: 3 Months
|
Physical activity and real-life mobility: 1-week accelerometry (actigraph)
|
3 Months
|
|
Questionnaires on quality of life (QoL, HAQUAMS)
Time Frame: 3 Months
|
Disease specific quality of life questionnaire
|
3 Months
|
|
Questionnaires on activities of daily living (ADL)
Time Frame: 3 Months
|
Frenchay activity index
|
3 Months
|
|
Questionnaires on physical activity
Time Frame: 3 Months
|
Godin Leisure time
|
3 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2016
Primary Completion (Anticipated)
May 30, 2017
Study Completion (Anticipated)
May 30, 2017
Study Registration Dates
First Submitted
March 31, 2017
First Submitted That Met QC Criteria
April 13, 2017
First Posted (Actual)
April 14, 2017
Study Record Updates
Last Update Posted (Actual)
May 3, 2017
Last Update Submitted That Met QC Criteria
May 2, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- inims-pia
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.