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

NCT ID: NCT07120854

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-03
• Study Completion Date: 2026-02-25

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.

Detailed Description

Open-label, randomized, open-label, multicenter, three parallel arms, controlled clinical trial. It will be carried out in primary care centers belonging to the Autonomous Communities of Madrid and Catalonia.

The participants will be recruited in the medical consultation, by their family doctor, who will assess the fulfillment of the inclusion criteria a priori and according to eligibility, will offer the woman to participate in the study, informing her about the nature of the research. The informed consent form will be signed online, and the inclusion criteria will be verified by the participant herself when accessing the tool. Participation will be voluntary and does not entail economic incentives for the participants.

Random assignment will be simple following a 1:1:1 ratio to each group. To avoid possible contamination bias, randomization will be performed at the physician level, so that each professional will be randomized to one of the intervention groups so that he/she will apply exclusively one of the study's interventions to all the participants he/she recruits. Due to the characteristics of the interventions it will not be possible to blind the interveners and participants. After randomization, only the data analysts will be blinded to the randomization sequence. The central research team will primarily contact participants via email to send the decision aid tool link and questionnaire links. They will also follow up to ensure the completion of all data provided by the participants.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Decision aid plus decision analysis model

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.

Group Type: EXPERIMENTAL

Decision aid with decision analysis model

Intervention Type: 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 only

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

Group Type: EXPERIMENTAL

Decision aid alone

Intervention Type: 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.

Control

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

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: 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.

Interventions

Decision aid with decision analysis model

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.

Intervention Type: OTHER

Decision aid alone

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.

Intervention Type: OTHER

Usual Care

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.

Intervention Type: OTHER

Other Intervention Names

Usual practice

Eligibility Criteria

Inclusion Criteria

• 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%.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Institut Catala de Salut

OTHER_GOV

Sponsor Role: collaborator

Servicio Madrileño de Salud, Madrid, Spain

OTHER

Sponsor Role: collaborator

Fondo de Investigacion Sanitaria

OTHER

Sponsor Role: collaborator

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institut de Recerca Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Countries

Spain

Other Identifiers

24/202-P

Identifier Type: -

Identifier Source: org_study_id