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

NCT03114293 | Unknown

• 1 other identifier: inims-pia
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multiple Sclerosis, Chronic Progressive

Keywords

Physical activity; Mobility

Outcome Measures

Primary Outcomes (1)

• 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 (6)

• Physical activity: total activity

  3 Months

• Physical activity: distance per day

  3 Months

• Physical activity: number of steps per day

  3 Months

• Questionnaires on quality of life (QoL, HAQUAMS)

  3 Months

• Questionnaires on activities of daily living (ADL)

  3 Months

Study Arms (2)

Waiting group

NO INTERVENTION

Waiting group

Smartphone intervention

EXPERIMENTAL

Smartphone bases behavioural intervention

Behavioral: Smartphone App

Interventions

Smartphone App BEHAVIORAL

The app includes an EBPI and physical activity feedback

Smartphone intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• progressive MS

You may not qualify if:

• other major health disorder
• EDSS above 6

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive; Motor Activity

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Rater blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Short, randomised waiting-group controlled explorative studies of a behavioural intervention.

Study Record Dates

• First Submitted: March 31, 2017
• First Posted: April 14, 2017
• Study Start: April 1, 2016
• Primary Completion: May 30, 2017
• Study Completion: May 30, 2017
• Last Updated: May 3, 2017

Record last verified: 2017-05