Evidence Based Patient Information and Smartphone Acceler... | NCT03114293

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

NCT03114293

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Status

Unknown status

Last Update Posted

May 3, 2017Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Multiple Sclerosis, Chronic Progressive

Interventions

Smartphone App

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2016Actual

Primary Completion Date

May 30, 2017Estimated

Completion Date

May 30, 2017Estimated

First Submitted Date

Mar 31, 2017

First Submission Date that Met QC Criteria

Apr 13, 2017

First Posted Date

Apr 14, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 2, 2017

Last Update Posted Date

May 3, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jan-Patrick Stellmann, MD, Universitätsklinikum Hamburg-EppendorfPrincipal Investigator

Lead Sponsor

Universitätsklinikum Hamburg-EppendorfOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Waiting group	No Intervention	Waiting group
Smartphone intervention	Experimental	Smartphone bases behavioural intervention	Behavioral: Smartphone App

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Smartphone App	Behavioral	The app includes an EBPI and physical activity feedback	Smartphone intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	3 Months

Secondary Outcomes

Measure	Description	Time Frame
Physical activity: total activity	Physical activity and real-life mobility: 1-week accelerometry (actigraph)	3 Months
Physical activity: distance per day	Physical activity and real-life mobility: 1-week accelerometry (actigraph)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

progressive MS

Exclusion Criteria:

other major health disorder
EDSS above 6

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020528	Multiple Sclerosis, Chronic Progressive
D009043	Motor Activity

Ancestor Terms

ID	Term
D009103	Multiple Sclerosis
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided