Development and Evaluation of a Web Based Decision Aid for Patients With Hip Osteoarthritis
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|ClinicalTrials.gov Identifier: NCT04241978|
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : March 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hip Osteoarthritis Osteoarthritis||Other: Patient Decision Aid (PtDA) Other: Brochure with general information about osteoarthritis||Not Applicable|
Background: Osteoarthritis (OA) is a health condition sensitive to patient's preferences and values regarding the benefits and risks of the different treatment options. In this sense, patient decision aids (PtDA) can play an important role in helping patients to incorporate their values, needs and preferences into the decision-making process, thus improving Person-Centred Care (PCC). Previous research has focused almost exclusively on knee OA, and therefore the aim of this study is to develop and evaluate the effectiveness of a PtDA for patients with hip OA.
Methods: The general design consists of two phases: 1) design a web-based PtDA for patients with hip OA, following the recommended procedures: systematic review of safety/effectiveness of treatments, and an iterative process of development with the help of an Advisory Committee composed of health professionals and patients; 2) To evaluate the impact of the PtDA on hip OA patients' decision-making process related with their treatment. For that aim, a multicenter randomized controlled trial will be carried out with 124 patients with hip OA in Tenerife (Spain) comparing intervention or usual care.
Discussion: PtDAs have been recommended as a useful and effective resource for improving PCC in many health conditions. The intervention is intended to empower patients by fostering their active participation during the decision-making process about their treatment, and by ensuring they make informed decisions congruent with their values and preferences. This study will contribute to the scientific knowledge about effectiveness of PtDAs in hip OA, in order to improve the quality of health care offered to these patients.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||124 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||The Effectiveness of a Web-based Decision Aid for Patients With Hip Osteoarthritis: Study Protocol for a Randomized Controlled Trial|
|Actual Study Start Date :||February 17, 2020|
|Estimated Primary Completion Date :||September 1, 2020|
|Estimated Study Completion Date :||December 30, 2020|
Experimental: Intervention group
The participants will complete the baseline assessment and will be asked to read the project information sheet. Then, patients allocated to the intervention group will review the PtDA accompanied by the researcher and will complete the questionnaires assessing the outcome measures, in the same web interface.
Other: Patient Decision Aid (PtDA)
Patient Decision Aid (PtDA) are tools that enables to promote and facilitate patients' involvement in medical decisions concerning their health
Other Name: Intervention
Active Comparator: Control group
Patients in the control group will follow the same procedure, but they will be given a brochure with general information about osteoarthritis of the hip, knee, ankle and foot instead of the PtDA
Other: Brochure with general information about osteoarthritis
Participants of the control group will be given a brochure with general information about osteoarthritis of the hip, knee, ankle and foot instead of the PtDA
Other Name: Control
- Decisional conflict regarding the treatment for Hip Osteoarthritis, measured by the Decisional Conflict Scale (DCS) [ Time Frame: Immediately after the intervention ]DCS is a 16-item self-reported scale widely used in PtDA research. It is composed of five subscales: uninformed, values, support, uncertainty and effectiveness. This is a 0-100 point scale, where a high score means more decisional conflict.
- Knowledge of the disease and treatments [ Time Frame: Before and immediately after the intervention ]A 7-item scale will be udes to assess patients' knowledge of the disease and treatments
- Values about characteristics of treatments [ Time Frame: Immediately after the intervention ]Patients will be asked to rate in a 0-10 scale the importance they attribute to different characteristics of treatment: mode of administration, improvement in pain and function, risk of mild and serious adverse effects, time until symptoms' improvement, duration of benefits, and in the case of arthroplasty, period of rehabilitation and risk of needing surgery revision.
- Treatment preference [ Time Frame: Immediately after the intervention ]Patients will be asked the treatment they prefer: physiotherapy, medication, intra-articular injections, arthroplasty, not sure
- Intention to undergo the preferred treatment [ Time Frame: Immediately after the intervention ]Assessed with one item ranging 0 (not sure) to 5 (completely sure)
- Concordance between values and intention to undergo arthroplasty vs. conservative treatments [ Time Frame: Immediately after the intervention ]Binary variable (yes/no) derived from the association between values and intention to undergo arthroplasty (see statistical analysis).
- Decision quality about arthroplasty [ Time Frame: Immediately after the intervention ]Binary variable (yes/no) defined as a combination of adequate knowledge (≥60% of correct responses) and concordance.
- Satisfaction with the decision making process scale [ Time Frame: Immediately after the intervention ]The Satisfaction with Decision Scale (SWD) is a validated 12-item scale measuring participants' satisfaction with healthcare decision making. The SWD uses a 5-point Likert scale where 0 is "Strongly Disagree" and 4 is "Strongly Agree." This is a 0-100 point scale, where a high score means more satisfaction with the decision making process.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04241978
|Contact: Pedro Serrano Aguilar, MD, PhDemail@example.com|
|Contact: Lilisbeth Perestelo Perez, PhDfirstname.lastname@example.org|
|Evaluation Unit. Canary Islands Health Service||Recruiting|
|Santa Cruz De Tenerife, Santa Cruz Tenerife, Spain, 38109|
|Contact: Lilisbeth Perestelo-Perez, PhD 0034922478321 email@example.com|
|Contact: Yolanda Alvarez-Perez, PhD 0034922478268 firstname.lastname@example.org|
|Principal Investigator:||Lilisbeth Perestelo Perez, PhD||Servicio de Evaluación de. Servicio Canario de Salud|