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Digital Motivation to Decrease Inactive Behaviour in Patients With Knee Osteoarthritis

This study is not yet open for participant recruitment.
Verified November 2017 by Marius Henriksen, Frederiksberg University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT03339011
First Posted: November 9, 2017
Last Update Posted: November 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Marius Henriksen, Frederiksberg University Hospital
  Purpose

Physical inactivity is a major risk behaviour with a potential for causing premature death, particularly among people with mobility limitations, such as knee osteoarthritis.

Digital motivational interventions (such as SMS) can motive to a healthy behaviour including increased physical activity.

The purpose of this study is to investigate if motivational text messages following an exercise intervention to improve mobility limitations will change the physical activity level in patients with knee osteoarthritis.

This study is designed as pilot randomized controlled trial, with equal randomization (1:1). Eligible participants will be randomised into one of two groups (intervention or control) after completing their baseline measurements. The intervention group will receive weekly motivational text messages and the control group will not receive any attention from the study.


Condition Intervention
Knee Osteoarthritis Behavioral: Motivational SMS text message

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effectiveness of Text Messages for Decreasing Inactive Behavior in Patients With Knee Osteoarthritis: a Pilot Randomised Controlled Study

Resource links provided by NLM:


Further study details as provided by Marius Henriksen, Frederiksberg University Hospital:

Primary Outcome Measures:
  • Change from baseline in physical inactivity [ Time Frame: 6 weeks ]
    Physical inactivity is measured using an accelerometer based activity monitor. Physical activity is defined as time (in minutes) spent inactive, i.e. lying, sitting, standing during a day.


Secondary Outcome Measures:
  • Change form baseline in the Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: 6 weeks ]
    The Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire is used to assess patient reported outcomes on pain, function, and quality of life.

  • Transition questionnaire (TRANS-Q) of perceived change in knee symptoms [ Time Frame: 6 weeks ]
    To investigate if participants experience a change in their osteoarthritis symptoms over time, they will be asked: "Pleas answer if you feel that your osteoarthritis symptoms have change for either the better, worse or no changes compared to before you entered this study" at the follow-up visit. The Participants can then check a box say: not change, a change for the worse or change for the better

  • Self-reported change in physical inactivity [ Time Frame: 6 weeks ]
    At the follow-up visit participants will be asked "Have you changed your physical activity behaviour after completing the motivational intervention". This question will be asked at the end of the intervention period to investigate if the objective measurement of sedentary behaviour is related to the participants own perceived behaviour.


Estimated Enrollment: 50
Anticipated Study Start Date: November 14, 2017
Estimated Study Completion Date: November 14, 2018
Estimated Primary Completion Date: November 14, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SMS text message

The content of the text messages is developed based on recommendation and advice from the Danish Health Authority about the importance of regular daily physical activity.

For 6 weeks, the text messages will be send three times per week, twice during the week days and once in the weekend, based on previous experience with SMS as motivation for chronic pain patients.

Behavioral: Motivational SMS text message
Motivational text messages delivered to the participants' mobile phones. The text messages contain motivational text and advice on physical activity.
No Intervention: No intervention
No attention from the study

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≤18
  • Diagnosed with knee osteoarthritis
  • Owner of a smart phone or tablet
  • Have just finished an exercise program for knee osteoarthritis

Exclusion Criteria:

  • Not able to read and understand Danish
  • Any condition, which in the opinion of the investigator would put the subject at increased safety risk by participation, or otherwise make the subject unsuitable for this study.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03339011


Locations
Denmark
The Parker Institute, Bispebjerg and Frederiksberg University Hospitals
Copenhagen, Denmark, 2000
Sponsors and Collaborators
Marius Henriksen
  More Information

Responsible Party: Marius Henriksen, Professor, Frederiksberg University Hospital
ClinicalTrials.gov Identifier: NCT03339011     History of Changes
Other Study ID Numbers: CB_IV
First Submitted: November 7, 2017
First Posted: November 9, 2017
Last Update Posted: November 9, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases