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Hip OsteoarthritisNCT04241978

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

A study testing Patient Decision Aid (PtDA) and Brochure with general information about osteoarthritis in people with Hip Osteoarthritis and Osteoarthritis, run by Servicio Canario de Salud at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Hip Osteoarthritis, Osteoarthritis
What is being tested?
Patient Decision Aid (PtDA) and Brochure with general information about osteoarthritis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
1 siteSpain
Study dates
17 Feb 2020to 3 Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with diagnosis of hip Osteoarthritis

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Spain1 site

  • Evaluation Unit. Canary Islands Health Service

    Santa Cruz de Tenerife, Santa Cruz Tenerife, 38109

Other trials in Spain

About this study

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

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

Read the 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.

Being tested
Patient Decision Aid (PtDA), Brochure with general information about osteoarthritis
Keywords
Hip osteoarthritis, Patient decision aids, Person-centred care, Randomized controlled trial, Shared decision-making, Web-based intervention
Medical subject headings
Osteoarthritis, Hip, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patient Decision Aid (PtDA)Other

    Also called Intervention

    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 osteoarthritisOther

    Also called Control

    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

Study groups in NCT04241978
Study groupRoleWhat they receive
Intervention groupExperimentalThe 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.
Receives: Other: Patient Decision Aid (PtDA)
Control groupActive comparatorPatients 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
Receives: Other: Brochure with general information about osteoarthritis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Decisional conflict regarding the treatment for Hip Osteoarthritis, measured by the Decisional Conflict Scale (DCS)

    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.

    Measured: Immediately after the intervention

Secondary outcomes (7)

  1. Knowledge of the disease and treatments

    A 7-item scale will be udes to assess patients' knowledge of the disease and treatments

    Measured: Before and immediately after the intervention

  2. Values about characteristics of treatments

    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.

    Measured: Immediately after the intervention

  3. Treatment preference

    Patients will be asked the treatment they prefer: physiotherapy, medication, intra-articular injections, arthroplasty, not sure

    Measured: Immediately after the intervention

  4. Intention to undergo the preferred treatment

    Assessed with one item ranging 0 (not sure) to 5 (completely sure)

    Measured: Immediately after the intervention

  5. Concordance between values and intention to undergo arthroplasty vs. conservative treatments

    Binary variable (yes/no) derived from the association between values and intention to undergo arthroplasty (see statistical analysis).

    Measured: Immediately after the intervention

  6. Decision quality about arthroplasty

    Binary variable (yes/no) defined as a combination of adequate knowledge (≥60% of correct responses) and concordance.

    Measured: Immediately after the intervention

  7. Satisfaction with the decision making process scale

    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.

    Measured: Immediately after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2020
  2. Study start17 Feb 2020
  3. Primary completion28 Feb 2023
  4. Study completion3 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04241978
Sponsor's protocol ID
PIFUN33/18
Status last verified
Dec 2023
First submitted
22 Jan 2020
Last updated
6 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32838800

Questions about this trial

What is this clinical trial studying?

A study testing Patient Decision Aid (PtDA) and Brochure with general information about osteoarthritis in people with Hip Osteoarthritis and Osteoarthritis, run by Servicio Canario de Salud at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Decisional conflict regarding the treatment for Hip Osteoarthritis, measured by the Decisional Conflict Scale (DCS) (time frame: Immediately after the intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04241978, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.

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