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Digital Motivation to Decrease Inactive Behaviour in Patients With Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Motivational SMS text message
Sponsored by
Marius Henriksen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Knee Osteoarthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Parker Institute, Bispebjerg and Frederiksberg University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

SMS text message

No intervention

Arm Description

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.

No attention from the study

Outcomes

Primary Outcome Measures

Change from baseline in physical inactivity
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)
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
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
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.

Full Information

First Posted
November 7, 2017
Last Updated
August 1, 2018
Sponsor
Marius Henriksen
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1. Study Identification

Unique Protocol Identification Number
NCT03339011
Brief Title
Digital Motivation to Decrease Inactive Behaviour in Patients With Knee Osteoarthritis
Official Title
Effectiveness of Text Messages for Decreasing Inactive Behavior in Patients With Knee Osteoarthritis: a Pilot Randomised Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
November 14, 2017 (Actual)
Primary Completion Date
July 29, 2018 (Actual)
Study Completion Date
July 29, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marius Henriksen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SMS text message
Arm Type
Experimental
Arm Description
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.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
No attention from the study
Intervention Type
Behavioral
Intervention Name(s)
Motivational SMS text message
Intervention Description
Motivational text messages delivered to the participants' mobile phones. The text messages contain motivational text and advice on physical activity.
Primary Outcome Measure Information:
Title
Change from baseline in physical inactivity
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change form baseline in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
The Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire is used to assess patient reported outcomes on pain, function, and quality of life.
Time Frame
6 weeks
Title
Transition questionnaire (TRANS-Q) of perceived change in knee symptoms
Description
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
Time Frame
6 weeks
Title
Self-reported change in physical inactivity
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
The Parker Institute, Bispebjerg and Frederiksberg University Hospitals
City
Copenhagen
ZIP/Postal Code
2000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31516729
Citation
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.
Results Reference
derived

Learn more about this trial

Digital Motivation to Decrease Inactive Behaviour in Patients With Knee Osteoarthritis

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