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Completed

NCT Number: NCT04241978

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

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

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Key information

Conditions

Hip Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Evaluation Unit. Canary Islands Health Service

Santa Cruz de Tenerife, Santa Cruz Tenerife, 38109, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Patient Decision Aid (PtDA)

Other

Patient Decision Aid (PtDA) are tools that enables to promote and facilitate patients' involvement in medical decisions concerning their health

Other names: Intervention

Brochure with general information about osteoarthritis

Other

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 names: Control

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Servicio Canario de Salud

Other

Collaborators

  • Avedis Donabedian Research Institute
  • Fundación Canaria Instituto de Investigación Sanitaria de Canarias
  • Gerencia de Atención Primaria del Área de Salud de Tenerife
  • Hospital San Juan de Dios Tenerife
  • Hospital Universitario de Canarias

Registry information

Official study title

The Effectiveness of a Web-based Decision Aid for Patients With Hip Osteoarthritis: Study Protocol for a Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 27, 2020
Registry last updated
Dec 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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