NCT07496359招募中不适用
Dyadic Management Intervention in Older People With Co-occurring Cognitive Impairment and Diabetes as a Supplementary Approach to Chronic Diseases Self-Management Program: A Hybrid Effectiveness-implementation Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 309
- 试验地点
- 1
- 主要终点
- Self-Care of Diabetes Index
研究概览
简要总结
The goal of this study is to evaluate the effectiveness and implementation of a dyadic management of the Chronic Disease Self-Management Program (CDSMP) for older adults with co-occurring cognitive impairment and diabetes with the involvement of caregivers.
The main questions it aims to answer are:
- Does the intervention improve diabetes self-management and cognitive function in older adults?
- How is the implementation of the intervention in real-world settings?
Participants will:
- Attend weekly CDSMP session over a 6-week period (2.5-hour per session).
- Provide feedback on their experience with the intervention through interviews and surveys.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals with DM aged >= 55 years old;
- •Recent glycosylated haemoglobin (HbA1c) level of 6.5% or above without change in diabetes medication within the last 3 months based on centre's records;
- •Subjective cognitive decline (using SCDQ21) (separately reported by the patient and/or caregiver) and confirmed by MOCA (Chinese version) screened by the research nurses;
- •Subjects with nominated primary caregivers will be recruited in the intervention group;
- •For caregivers: they will be considered in the project if they have been the primary caregiver for the person for at least 1 year and are providing or involved in the patient's care on a daily basis.
排除标准
- •Medical diagnoses of dementia;
- •Those who have terminal illness;
- •For caregivers: those who are temporary caregivers and have only provided/involved in care for less than a year.
研究组 & 干预措施
CDSMP
Experimental
Participants in the intervention group will receive a 6-week CDSMP course plus support from one informal caregiver throughout the program.
干预措施: CDSMP + caregiver support (Behavioral)
Usual care
Active Comparator
User care will receive diabetes education, glucose monitoring, and medical consultations, but no informal caregiver support.
干预措施: Usual Care (Behavioral)
结局指标
主要结局
Self-Care of Diabetes Index
时间窗: From enrollment to 6 months after the intervention begins
Self-Care of Diabetes Index (SCODI) is a scale, scoring from 0 to 100, where higher scores indicate better self-care for diabetes.
次要结局
- Glycated hemoglobin (HbA1c)(From enrollment to 6 months after the intervention begins)
- Subjective Cognitive Decline Questionnaire 21(From enrollment to 6 months after the intervention begins)
- Montreal Cognitive Assessment(From enrollment to 6 months after the intervention begins)
- Caregiver Contribution to Self-Care of Diabetes Inventory(From enrollment to 6 months after the intervention begins)
- Caregiver Burden Inventory(From enrollment to 6 months after the intervention begins)
- Implementation Outcome: Acceptability of Intervention Measure(From 3 months after the intervention begins to 6 months after the intervention begins)
- Implementation Outcome: Intervention Appropriateness Measure(From 3 months after the intervention begins to 6 months after the intervention begins)
- Implementation Outcome: Feasibility of Intervention Measure(From 3 months after the intervention begins to 6 months after the intervention begins)
- Implementation Outcome: Adoption(From 3 months after the intervention begins to 6 months after the intervention begins)
- Implementation Outcome: Fidelity(From 3 months after the intervention begins to 6 months after the intervention begins)
- Implementation Outcome: Cost(From 3 months after the intervention begins to 6 months after the intervention begins)
- Implementation Outcome: Penetration(From 3 months after the intervention begins to 6 months after the intervention begins)
- Implementation Outcome: Sustainability(From 3 months after the intervention begins to 6 months after the intervention begins)
研究者
研究点 (1)
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