Development and Validation of a Propensity-to-change Scale in the Field of Chronic Disease Prevention: the ProChange Scale
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 290
- 试验地点
- 1
- 主要终点
- Development of the Prochange scale assessing barriers to and facilitators of lifestyle changes for the adoption of non-pharmacological strategies in the field of prevention.
研究概览
简要总结
Modifiable risk factors are estimated to account for 70% of cardiovascular diseases, 40% of Alzheimer's-type dementias, and 50% of type 2 diabetes cases. Numerous trials have evaluated interventions aimed at modifying these risk factors, whether through the promotion of healthy lifestyle choices (diet, physical activity, etc.) or specific activities (cognitive training, etc.). However, these trials have yielded inconsistent or modest results, potentially due to a failure to adopt the recommended lifestyle changes. To better tailor prevention interventions, it is therefore essential to have scales available that measure the barriers to and facilitators of lifestyle change.
The aim of this study is to develop and validate a Patient-Reported Outcome Measure (PROM) to assess the barriers to and facilitators of change following participation in a prevention program. The scale will be structured into three sub-scales (capability, opportunity, and motivation), administered one month after the prevention activity, and will distinguish between the adoption of new habits and the abandonment of existing ones.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant receiving a personalized prevention intervention through the frailty assessment day-hospital program, the Atherosclerosis Detection and Prevention Center (CDPA), or the Salutance program,
- •Participant who has received prevention advice aimed at improving their health in at least one of the following two areas: nutrition or physical activity,
- •Participant aged 45 or older (we are targeting a middle-aged to older population, as this group is the primary target for cardiovascular prevention initiatives and efforts to prevent pathological aging),
排除标准
- •Participant unable to improve their lifestyle, according to the scales used in the study (participant with a maximum score on the ONAPS-PAQ scale and the food frequency score),
- •Participant without a postal or email address,
- •Participant with a life expectancy of less than 5 years.
研究组 & 干预措施
Patients benefiting from a personalized prevention initiative
patients benefiting from a personalized prevention initiative aimed at improving nutritional or physical health
干预措施: Scale development phase (Other)
Patients benefiting from a personalized prevention initiative
patients benefiting from a personalized prevention initiative aimed at improving nutritional or physical health
干预措施: Beta testing phase (Other)
Patients benefiting from a personalized prevention initiative
patients benefiting from a personalized prevention initiative aimed at improving nutritional or physical health
干预措施: Validation phase (Other)
结局指标
主要结局
Development of the Prochange scale assessing barriers to and facilitators of lifestyle changes for the adoption of non-pharmacological strategies in the field of prevention.
时间窗: 3 months after the inclusion
Development of a scale based on COSMIN criteria (COnsensus-based Standards for the selection of health Measurement INstruments), consisting of three subscales of 10 questions each.
次要结局
- Measurement of the area under the curve of the Prochange scale for the prediction of an improvement in lifestyle at 3 months after the initiation of a preventive action(3 months after the inclusion)
- Comparison of the performance of the ProChange scale with that of pre-existing scales in predicting lifestyle change three months after the initiation of a prevention intervention.(3 months after the inclusion)
- Evaluation of the correlation between the score obtained on the ProChange scale one month after the prevention intervention and the extent of lifestyle modification three months after the initiation of the prevention intervention(3 months after the inclusion)
- Comparison of the ProChange scale with pre-existing scales(3 months after the inclusion)