Development and Evaluation of a Web Based Decision Aid for Patients With Hip Osteoarthritis
NCT ID: NCT04241978
Last Updated: 2023-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
130 participants
INTERVENTIONAL
2020-02-17
2023-04-03
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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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.
Patient Decision Aid (PtDA)
Patient Decision Aid (PtDA) are tools that enables to promote and facilitate patients' involvement in medical decisions concerning their health
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
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
Interventions
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Patient Decision Aid (PtDA)
Patient Decision Aid (PtDA) are tools that enables to promote and facilitate patients' involvement in medical decisions concerning their health
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Fundación Canaria de Investigación Sanitaria
OTHER
Hospital Universitario de Canarias
OTHER
Hospital San Juan de Dios Tenerife
OTHER
Avedis Donabedian Research Institute
OTHER
Gerencia de Atención Primaria del Área de Salud de Tenerife
UNKNOWN
Servicio Canario de Salud
OTHER
Responsible Party
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Lilisbeth Perestelo-Perez
Health Services Researcher
Principal Investigators
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Lilisbeth Perestelo Perez, PhD
Role: PRINCIPAL_INVESTIGATOR
Servicio de Evaluación de. Servicio Canario de Salud
Locations
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Evaluation Unit. Canary Islands Health Service
Santa Cruz de Tenerife, Santa Cruz Tenerife, Spain
Countries
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References
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Perestelo-Perez L, Alvarez-Perez Y, Rivero-Santana A, Ramos-Garcia V, Duarte-Diaz A, Torres-Castano A, Toledo-Chavarri A, Herrera-Perez M, Pais-Brito JL, Del Castillo JC, Vazquez JR, Orrego C, Serrano-Aguilar P. The effectiveness of a web-based decision aid for patients with hip osteoarthritis: study protocol for a randomized controlled trial. Trials. 2020 Aug 24;21(1):736. doi: 10.1186/s13063-020-04661-z.
Other Identifiers
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PIFUN33/18
Identifier Type: -
Identifier Source: org_study_id