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Digital Motivation to Decrease Inactive Behaviour in Patients With Knee Osteoarthritis

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03339011
Recruitment Status : Completed
First Posted : November 9, 2017
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
Marius Henriksen, Frederiksberg University Hospital

Tracking Information
First Submitted Date  ICMJE November 7, 2017
First Posted Date  ICMJE November 9, 2017
Last Update Posted Date August 2, 2018
Actual Study Start Date  ICMJE November 14, 2017
Actual Primary Completion Date July 29, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2017)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Digital Motivation to Decrease Inactive Behaviour in Patients With Knee Osteoarthritis
Official Title  ICMJE Effectiveness of Text Messages for Decreasing Inactive Behavior in Patients With Knee Osteoarthritis: a Pilot Randomised Controlled Study
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Knee Osteoarthritis
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.

    Intervention: Behavioral: Motivational SMS text message
  • No Intervention: No intervention
    No attention from the study
Publications * Bartholdy C, Bliddal H, Henriksen M. Effectiveness of text messages for decreasing inactive behaviour in patients with knee osteoarthritis: a pilot randomised controlled study. Pilot Feasibility Stud. 2019 Sep 7;5:112. doi: 10.1186/s40814-019-0494-6. eCollection 2019.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 15, 2018)
38
Original Estimated Enrollment  ICMJE
 (submitted: November 7, 2017)
50
Actual Study Completion Date  ICMJE July 29, 2018
Actual Primary Completion Date July 29, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03339011
Other Study ID Numbers  ICMJE CB_IV
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Marius Henriksen, Frederiksberg University Hospital
Study Sponsor  ICMJE Marius Henriksen
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Frederiksberg University Hospital
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP