NCT04241978

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
21 days until next milestone

Study Start

First participant enrolled

February 17, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2023

Completed
Last Updated

December 6, 2023

Status Verified

December 1, 2023

Enrollment Period

3 years

First QC Date

January 22, 2020

Last Update Submit

December 5, 2023

Conditions

Hip OsteoarthritisOsteoarthritis

Keywords

Hip osteoarthritisPatient decision aidsPerson-centred careRandomized controlled trialShared decision-makingWeb-based intervention

Outcome Measures

Primary Outcomes (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.

    Immediately after the intervention

Secondary Outcomes (7)

  • Knowledge of the disease and treatments

    Before and immediately after the intervention

  • Values about characteristics of treatments

    Immediately after the intervention

  • Treatment preference

    Immediately after the intervention

  • Intention to undergo the preferred treatment

    Immediately after the intervention

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

    Immediately after the intervention

  • +2 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

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)

Control group

ACTIVE COMPARATOR

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

Interventions

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

Also known as: Intervention
Intervention group
Brochure with general information about osteoarthritisOTHER

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

Also known as: Control
Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with diagnosis of hip Osteoarthritis

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Evaluation Unit. Canary Islands Health Service

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

Location

Related Publications (1)

  • 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.

    PMID: 32838800DERIVED

MeSH Terms

Conditions

Osteoarthritis, HipOsteoarthritis

Interventions

Methods

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Lilisbeth Perestelo Perez, PhD

    Servicio de Evaluación de. Servicio Canario de Salud

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Health Services Researcher

Study Record Dates

First Submitted

January 22, 2020

First Posted

January 27, 2020

Study Start

February 17, 2020

Primary Completion

February 28, 2023

Study Completion

April 3, 2023

Last Updated

December 6, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)