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
Behavioral: Smartphone App
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.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

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.

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