Effect of an Information- and Self-management App for People With Knee Osteoarthritis
ConditionKnee Osteoarthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorDiakonhjemmet Hospital
About this trial
The primary aim of the trial is to assess if an information- and self-management app provided in the period between referral and consultation in specialist healthcare can improve knowledge about osteoarthritis and decision quality during consultation in patients with knee osteoarthritis.
204 patients will be randomized to either being on the waiting list for consultation, accessing publically available information about osteoarthritis (control group) or getting access to an 8-week information- and self-management intervention delivered through the Genus app prior to consultation.
Pasients with answer questionnaires at baseline, 4 weeks (intervention group only), 8 weeks, post consultation and 1 and 2 years after consultation.
The Genus app contains information videos, exercise videos, quizzes, feedback and questionnaires provided in a progressive order over an 8 week period.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men and women > 50 years referred to specialist healthcare for knee OA management
Disqualifiers
Received joint replacement or are under consideration for revision in the referred joint
Have undergone joint replacement surgery in opposite knee
Have uncontrolled serious comorbidities
Have cognitive deficits
Trial design
Design model
Parallel
Treatments tested in this trial
Information- and self-management app
DeviceAn information- and self-management intervention delivered through the Genus app, including information videos, exercise videos, questionnaires, quizzes and feedback provided over an 8 week period prior to consultation in specialist healthcare
Control
Other interventionInformation on where to access publically available information about knee osteoarthritis
Treatment groups
204 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Knee Osteoathritis Knowlegde Scale (KOAKS)
11 statements about osteoarthritis and treatment options, answered on a 5-point scale from 1 (=true) to 5 (=not true), summed up to a scale from 11 to 55
Time frame
Baseline, 8 weeks, approx. 2-4 months after baseline (1 day after consultation (post consultation))2
Decision Conflict Scale (DCS)
16 statements with 5 response categories about the patients uncertainty with treatment options. The total score range from 0 (no decisional conflict) to 100 (extreme decisional conflict). The DCS also has five subscales (all 0-100): 1) uncertainty, 2) informed, 3) values clarity, 4) support, and 5) effective decision.
Time frame
approx. 2-4 months after baseline (1 day after consultation (post consultation))Secondary outcomes
1
Concordance between preferences and treatment decision
Measured with one qustion form the Decision Conflict Scale (DSC), 5 response options.
Time frame
approx. 2-4 months after baseline (1 day after consultation (post consultation))2
Decisional quality
Measured with section 3 (decision process scale) in the Decision Quality Index for Knee Osteoarthritis (K-DQI) which consists of 5 questions. Four of these questions are summed to a 0-4 score with higher score indicating more shared decision-making.
Time frame
approx. 2-4 months after baseline (1 day after consultation (post consultation))3
Level of shared decision-making
Mesured with the CollaboRATE questionnaire, comprising 3 questions measured on a 0-9 scale, with a higher score indicating better experience. Scores are calculated using the top score method indicating the percentage of patients scoring top score for all three questions, or
Time frame
approx. 2-4 months after baseline (1 day after consultation (post consultation))4
Satisfaction with treatment choice
Measured on a numeric rating scale (0-10, with higher score indicating more satisfaction)
Time frame
approx. 2-4 months after baseline (1 day after consultation (post consultation))Other outcomes
1
Motivation for exercise
Measured on a numeric rating scale from 0 to 10 with higher score indicating higher motivation
Time frame
Baseline, 4 weeks (only intervention group), 8 weeks2
Motivation for surgery
Measured on a numeric rating scale from 0 to 10 with higher score indicating higher motivation
Time frame
Baseline, 4 weeks (only intervention group), 8 weeks3
Assessment of knee-related pain
Measured with the Knee Injury and Osteoarthritis Outcome Score (pain section), comprising 9 questions scored on a 5-point scale and calculated to a 0-100 score with higher score indicating less pain
Time frame
Baseline, 4 weeks (only intervention group), 8 weeks, 1 and 2 years4
Assessment of knee-related function
Measured with the Knee Injury and Osteoarthritis Outcome Score (function section), comprising 17 questions scored on a 5-point scale and calculated to a 0-100 score with higher score indicating less pain
Time frame
Baseline, 4 weeks (only intervention group), 8 weeks, 1 and 2 yearsSponsors and contacts
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Source ClinicalTrials.gov