Evaluation of a Decision Analysis Model in the DASH-Osteo Decision Aid.

NCT07120854 | Enrolling By Invitation

• 1 other identifier: 24/202-P
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

Fragility fractures, often caused by low bone mineral density, are a major health concern for postmenopausal women. One way to prevent these fractures is by taking medication, but deciding whether to start treatment can be difficult due to potential risks and side effects. This study will test a web-based tool designed to help women make informed decisions about fracture prevention treatment. The tool provides information about the benefits and risks of treatment. Some women in the study will also receive additional support through a decision analysis report, which helps weigh different factors when making a choice. The study will examine whether using this tool improves decision-making, increases confidence in making a choice, and enhances satisfaction with the decision. It will also explore what factors influence women's decisions and at what level of risk they choose to start treatment. By understanding how decision aids impact choices, researchers aim to improve the way healthcare providers support patients in making informed decisions about their health.

Conditions

Osteoporosis, Postmenopausal; Osteoporotic Fractures; Diphosphonates; Fracture Risk Assessment

Keywords

postmenopausal; osteoporotic fractures; primary prevention

Outcome Measures

Primary Outcomes (1)

• Decisional conflict

  We will use the Decisional conflict scale (O'Connor 1998, updated 2010), to evaluate the uncertainty and the decision-making conflict across participants. It is a 16-item scale. IItems are summed, then multiplied by 25. Scoring goes from 0 (low decisional conflict) to 100 (high decisional conflict). Patients with a total score \>38 tend to delay decisions, whereas those with ≤ 25 tend to make decisions(1, 2) 1. O'Connor AM. Validation of a Decisional Conflict Scale. Med Decis Making \[Internet\]. 1995 Feb;15(1):25-30. Available from: http://dx.doi.org/10.1177/0272989X9501500105 2. Bunn H, O'Connor A. Validation of Client Decision-Making Instruments in the Context of Psychiatry. Can J Nurs Res \[Internet\]. 1996;28(3):13-27. Available from: https://pubmed.ncbi.nlm.nih.gov/8997937/

  Decisional conflict will be measured one time up to 26 weeks, after participant use of the web-based tool.

Secondary Outcomes (2)

• Decision self-efficacy

  Decision-Self-efficacy scale will be applied, up to 26 weeks, after using the decision aid tool.

• Participant satisfaction with the decision process

  Satsfaction will be assessed up to 26 weeks, after participant's second visit with their physician.

Study Arms (3)

Decision aid plus decision analysis model

EXPERIMENTAL

Participants in this group will use DASH-Osteo decision aid plus the information in plain language, provided by a decision analysis model which will include the utilities provided by the same participants in the web- based tool, and will make a shared decision with their healthcare professional.

Other: Decision aid with decision analysis model

Decision aid only

EXPERIMENTAL

Participants in this group will use DASH-osteo decision and will make a shared decision with their healthcare professional.

Other: Decision aid alone

Control

ACTIVE COMPARATOR

Participants in this group will make a decision according to centre's usual practice

Other: Usual Care

Interventions

Decision aid with decision analysis model OTHER

Women will use the web version of the decision aid tool. They will have a supporting video to help them how to navigate the tool during. They will be able to access the tool through a specific link that will be shared with them by their central research team via e-mail. Each woman is expected to use the web tool and select her preferences (utilities) regarding different health conditions (e.g. hip fracture). The results of the exercises will be received automatically at the central level (by institutional e-mail to the researcher responsible for the data a PDF file will be sent from the web). The research team at the central level will apply the decision analysis model, using information on the baseline fracture risk and preferences of each participant entered into the tool. The results of the decision analysis model will be delivered to the women directly by e-mail in plain language, so that they can make the final decision together with their general practitioner in a second visit.

Decision aid plus decision analysis model

Decision aid alone OTHER

Participants will use the web tool. They will have a supporting video to help them how to navigate the tool during. They will be able to access the tool through a specific link that will be shared with them by the central research team via e-mail. Each woman is expected to navigate through the different functions of the web tool, at home or at a time other than the medical visit, and select her preferences (utilities) with respect to different health conditions (e.g. hip fracture). The women in this group would decide whether or not to take the pharmacological treatment based on the information provided by the tool but without the results of the decision analysis model described for the intervention group. Subsequently, those who wished to do so would make a final decision together with their physician at a second visit.

Decision aid only

Usual Care OTHER

Women in this group will receive standard clinical practice, without the use of the shared decision support tool or the decision analysis model or any other support. At the end of the visit, their physician will provide them with a link to access the assessment questionnaires.

Also known as: Usual practice

Control

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: As fragility fracture risk is higher in older women due to their estrogen decrease. We will include only postmenopausal women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal women older than 50 years
• No medical history of fragility fractures
• With or without a BMD measurement performed
• Having been considered candidates to pharmacological treatment prevention for fragility fractures.
• A 10 year fracture risk assessment according to FRAX for Major fracture \>5%.

You may not qualify if:

• women with a history of fragility fracture
• being treated with bisphosphonates or other osteoporosis drugs (except for vitamin D and calcium supplements
• suffer from serious concomitant pathologies (cancer, chronic renal insufficiency, etc.)
• women under permanent treatment with glucocorticoids.

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead
• Institut Catala de Salut: collaborator
• Servicio Madrileño de Salud, Madrid, Spain: collaborator
• Fondo de Investigacion Sanitaria: collaborator

Study Sites (1)

Institut de Recerca Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal; Osteoporotic Fractures

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 13, 2025
• Study Start: April 3, 2025
• Primary Completion: December 20, 2025
• Study Completion: February 25, 2026
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)