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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
Sponsor:
Collaborators:
Fundación Canaria de Investigación Sanitaria
Hospital Universitario de Canarias
Hospital San Juan de Dios Tenerife
Avedis Donabedian Research Institute
Gerencia de Atención Primaria del Área de Salud de Tenerife
Information provided by (Responsible Party):
Lilisbeth Perestelo-Perez, Servicio Canario de Salud

Brief Summary:
The main goal of this study is assess the effectiveness of a PtDA for patients with hip osteoarthritis

Condition or disease Intervention/treatment Phase
Hip Osteoarthritis Osteoarthritis Other: Patient Decision Aid (PtDA) Other: Brochure with general information about osteoarthritis Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. Treatment preference [ Time Frame: Immediately after the intervention ]
    Patients will be asked the treatment they prefer: physiotherapy, medication, intra-articular injections, arthroplasty, not sure

  4. Intention to undergo the preferred treatment [ Time Frame: Immediately after the intervention ]
    Assessed with one item ranging 0 (not sure) to 5 (completely sure)

  5. 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).

  6. 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.

  7. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with diagnosis of hip Osteoarthritis

Exclusion Criteria:

  • Patients younger than 18 years
  • Previous hip arthroplasty
  • Patients with terminal illnesses
  • Non-fluent Spanish language
  • Mental or sensory alterations that impede or hinder the response to the measurement instruments or do not have the capacity to make decisions.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04241978


Contacts
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Contact: Pedro Serrano Aguilar, MD, PhD +34922478271 pseragu@gobiernodecanarias.org
Contact: Lilisbeth Perestelo Perez, PhD 922478321 lilisbeth.peresteloperez@sescs.es

Locations
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Spain
Evaluation Unit. Canary Islands Health Service Recruiting
Santa Cruz De Tenerife, Santa Cruz Tenerife, Spain, 38109
Contact: Lilisbeth Perestelo-Perez, PhD    0034922478321    lilisbeth.peresteloperez@sescs.es   
Contact: Yolanda Alvarez-Perez, PhD    0034922478268    yolanda.alvarezperez@sescs.es   
Sponsors and Collaborators
Servicio Canario de Salud
Fundación Canaria de Investigación Sanitaria
Hospital Universitario de Canarias
Hospital San Juan de Dios Tenerife
Avedis Donabedian Research Institute
Gerencia de Atención Primaria del Área de Salud de Tenerife
Investigators
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Principal Investigator: Lilisbeth Perestelo Perez, PhD Servicio de Evaluación de. Servicio Canario de Salud
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Responsible Party: Lilisbeth Perestelo-Perez, Health Services Researcher, Servicio Canario de Salud
ClinicalTrials.gov Identifier: NCT04241978    
Other Study ID Numbers: PIFUN33/18
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: March 19, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lilisbeth Perestelo-Perez, Servicio Canario de Salud:
Hip osteoarthritis
Patient decision aids
Person-centred care
Randomized controlled trial
Shared decision-making
Web-based intervention
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases