Development and Evaluation of a Web Based Decision Aid for Patients With Hip Osteoarthritis

Servicio Canario de Salud

Status: Completed

Conditions: Osteoarthritis; Hip Osteoarthritis

Treatments: Other: Brochure with general information about osteoarthritis; Other: Patient Decision Aid (PtDA)

Study type: Interventional

Funder types: Other

Identifiers

NCT04241978

PIFUN33/18

Details and patient eligibility

About

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

Full 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.

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

Intervention group

Experimental group

Description:

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.

Treatment:

Other: Patient Decision Aid (PtDA)

Control group

Active Comparator group

Description:

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

Treatment:

Other: Brochure with general information about osteoarthritis