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

NCT ID: NCT03114293

Last Updated: 2017-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-01

Study Completion Date

2017-05-30

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis, Chronic Progressive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Short, randomised waiting-group controlled explorative studies of a behavioural intervention.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Rater blinded.

Study Groups

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Waiting group

Waiting group

Group Type NO_INTERVENTION

No interventions assigned to this group

Smartphone intervention

Smartphone bases behavioural intervention

Group Type EXPERIMENTAL

Smartphone App

Intervention Type BEHAVIORAL

The app includes an EBPI and physical activity feedback

Interventions

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Smartphone App

The app includes an EBPI and physical activity feedback

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* progressive MS

Exclusion Criteria

* other major health disorder
* EDSS above 6
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Jan-Patrick Stellmann

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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inims-pia

Identifier Type: -

Identifier Source: org_study_id

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