Optimizing Implementation of the Intensive Diabetes Prevention Program in District Health Centres: A Hybrid Type 3 Study to Enhance Recruitment and Retention for Prediabetes Management
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 170
- 主要终点
- Recruitment rate
研究概览
简要总结
The goal of this clinical trial is to explore the effectiveness and implementation outcomes of the optimized Intensive Diabetes Prevention Program (IDPP) in District Health Centres. The main questions it aims to answer are:
- Do the implementation strategies - patient engagement system, structured training, and reminder systems - work better than usual approaches in terms of acceptability, adoption, appropriateness, feasibility, sustainability, and implementation cost?
- Do patient health outcomes - HbA1c levels, BMI, lipid profile, quality of life, perception of empowerment, and health service utilization - stay the same or get better when these improved strategies are used compared to usual approaches?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The research team staff and participants will be masked for the group allocation during the whole process.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being 18 years of age or above
- •Having a baseline HbA1c within the prediabetes range (6.0%-6.4%)
- •Holding a scheduled appointment at a DHC
排除标准
- •Having a diagnosis of diabetes mellitus
- •Currently using of oral hypoglycaemic agents or medications known to induce significant weight changes
- •Having medical conditions that would limit participation, such as active cancer or cognitive impairment
研究组 & 干预措施
Intervention group
The intervention group will follow the same one-year IDPP structure as the control group, but will experience a series of optimized implementation strategies including adding pre-implementation staff training, two enhanced nurse consultations, a structured reminder and follow-up system, and sustainment strategies.
干预措施: Optimized IDPP (Behavioral)
Control group
Participants in the control group will receive the standard IDPP as routinely delivered by the DHCs, without additional engagement or implementation strategies. This includes up to four optional group education sessions, two annual nurse-led consultations, and up to three individual counselling sessions per year.
干预措施: Standard IDPP (Behavioral)
结局指标
主要结局
Recruitment rate
时间窗: One year
Recruitment rate will be defined as the proportion of eligible individuals at participating DHCs who are successfully recruited into the study.
Retention rate
时间窗: One year
Retention rate will be defined as the percentage of enrolled participants who complete both scheduled nurse-led consultations and attend at least two of the four group education sessions within the 12-month intervention period.
Acceptability
时间窗: One year
Acceptability will be assessed through semi-structured focus group interviews with participants and providers after the implementation phase. Participants will share their satisfaction with key program components, and discuss perceived benefits and challenges. Providers will reflect on the practicality and relevance of the training sessions and enhanced workflows, and how these strategies affected their ability to deliver the IDPP effectively.
Participant adherence
时间窗: One year
Participant adherence will be measured using attendance records from nurse consultations and group workshops.
Provider adherence
时间窗: One year
Provider adherence will be assessed through meeting logs and fidelity checklists that capture consistent application of optimized protocols in clinical practice.
Appropriateness
时间窗: One year
Appropriateness will be evaluated through semi-structured interviews with key stakeholders, including DHC managers, nurses, dietitians, physiotherapists, and participants. Interviews will explore how well the optimized implementation strategies fit within existing DHC workflows, address operational challenges, and support patient engagement.
Fidelity
时间窗: One year
Fidelity, defined as the extent to which implementation strategies are delivered consistently and as intended, will be assessed using structured performance checklists completed by the PI during random audits of nurse consultations, along with reviews of audio-recorded sessions and provider self-reported logs.
Implementation cost
时间窗: One year
Implementation cost will be assessed from an organizational perspective by capturing direct costs associated with delivering the optimized IDPP. Data will include staff time and operational expenses, with incremental cost-effectiveness analyses conducted alongside sensitivity analyses to test key cost assumptions; results will be presented using cost-effectiveness planes and bootstrapped confidence intervals.
Sustainability
时间窗: 1.5 years
Sustainability will be evaluated by examining the extent to which optimized strategies remain embedded in routine DHC operations after external research support concludes. Focus groups with DHC managers and nurses at the end of the sustainment phase will explore long-term feasibility, while metrics will assess continued use of optimized workflows, provider adherence to protocols, and sustained patient engagement.
次要结局
- Changes in HbA1c(Baseline, six months, one year, 1.5 years)
- Lipid profile(Baseline, six months, one year, 1.5 years)
- Weight(Baseline, six months, one year, 1.5 years)
- Height(Baseline, six months, one year, 1.5 years)
- Perceptions of empowerment(Baseline, six months, one year, 1.5 years)
- Quality of Life (QoL)(Baseline, six months, one year, 1.5 years)
- Health service utilization(Baseline, six months, one year, 1.5 years)
研究者
Arkers, Wong
Associate Professor
The Hong Kong Polytechnic University