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PIA: Evidence Based Patient Information and Smartphone Accelerometry to Enhance Physical Activity in MS

Sponsor
Universitätsklinikum Hamburg-Eppendorf (Other)
Overall Status
Unknown status
CT.gov ID
NCT03114293
Collaborator
(none)
40
Enrollment
2
Arms
13.9
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Smartphone App
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Short, randomised waiting-group controlled explorative studies of a behavioural intervention.Short, randomised waiting-group controlled explorative studies of a behavioural intervention.
Masking:
Double (Investigator, Outcomes Assessor)
Masking Description:
Rater blinded.
Primary Purpose:
Treatment
Official Title:
Evidence Based Patient Information and Smartphone Accelerometry to Enhance Physical Activity in MS
Actual Study Start Date :
Apr 1, 2016
Anticipated Primary Completion Date :
May 30, 2017
Anticipated Study Completion Date :
May 30, 2017

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Waiting group

Waiting group
Experimental: Smartphone intervention

Smartphone bases behavioural intervention

Behavioral: Smartphone App
The app includes an EBPI and physical activity feedback

Outcome Measures

Primary Outcome Measures

  1. Rate of responders [3 Months]

    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

  1. Physical activity: total activity [3 Months]

    Physical activity and real-life mobility: 1-week accelerometry (actigraph)

  2. Physical activity: distance per day [3 Months]

    Physical activity and real-life mobility: 1-week accelerometry (actigraph)

  3. Physical activity: number of steps per day [3 Months]

    Physical activity and real-life mobility: 1-week accelerometry (actigraph)

  4. Questionnaires on quality of life (QoL, HAQUAMS) [3 Months]

    Disease specific quality of life questionnaire

  5. Questionnaires on activities of daily living (ADL) [3 Months]

    Frenchay activity index

  6. Questionnaires on physical activity [3 Months]

    Godin Leisure time

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • progressive MS
Exclusion Criteria:

  • other major health disorder

  • EDSS above 6

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Universitätsklinikum Hamburg-Eppendorf

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jan-Patrick Stellmann, MD, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT03114293
Other Study ID Numbers:
  • inims-pia
First Posted:
Apr 14, 2017
Last Update Posted:
May 3, 2017
Last Verified:
May 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jan-Patrick Stellmann, MD, Universitätsklinikum Hamburg-Eppendorf
Physical activity
Mobility
Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive

Study Results

No Results Posted as of May 3, 2017