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

Официальное название

Evaluation of a Decision Analysis Model in a Decision Aid for Fracture Prevention in Postmenopausal Women: Randomized Clinical Trial.

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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 ins
• Другое 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
• Другое 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.

Первичные конечные точки

• Decisional conflict [Срок оценки: Decisional conflict will be measured one time up to 26 weeks, after participant use of the web-based tool.]

Вторичные конечные точки (2)

• Decision self-efficacy [Срок оценки: Decision-Self-efficacy scale will be applied, up to 26 weeks, after using the decision aid tool.]
• Participant satisfaction with the decision process [Срок оценки: Satsfaction will be assessed up to 26 weeks, after participant's second visit with their physician.]

Критерии участия

Критерии включения

• 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%.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Испания · 1 центр

• Institut de Recerca Hospital de la Santa Creu i Sant Pau — Barcelona

Идентификаторы

NCT: NCT07120854 · 24/202-P

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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