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
About this trial
This is an interventional supportive care trial for Knee Osteoarthritis
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.
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
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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