Addressing Uncontrolled Diabetes in Primary Care: A Lifestyle Redesign Approach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 1
- 主要终点
- Difference in the daily rate of change of Glycated hemoglobin (HbA1C) during the year prior to baseline, compared to the period from baseline to post-intervention
研究概览
简要总结
This study is examining the feasibility of implementing an occupational therapy intervention addressing diabetes management in a primary care clinic within the Los Angeles County Department of Health Services (LAC-DHS), as well as the impact of this intervention approach on clinical outcomes, efficiency and patient-centeredness of care. This implementation science study is evaluating two emerging trends in healthcare delivery: (1) the integration of nontraditional providers into primary care medical home (PCMH) settings to facilitate the delivery of high-quality, comprehensive primary care while reducing the burden on physicians; and (2) the potential value of using occupational therapists to address chronic disease management in this setting
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
- None
盲法说明
This is an implementation trial being conducted in a real-world clinical setting in which masking is not appropriate.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current patient at Los Angeles County-USC Medical Center Adult West Primary Care clinic
- •Diagnosed diabetes (type 1 or type 2) documented in EMR
- •Most recent HbA1c level >9.0% OR has not had an HbA1c measurement within past 12 months
- •Per provider judgment, would be willing to make lifestyle changes related to diabetes self-care
排除标准
- •Active, untreated substance use or behavioral health disorder which interferes with participation in major life activities
研究组 & 干预措施
Usual Care Control
Participants will not be contacted; outcome data will be extracted from medical records.
Intervention
Participants will be invited to enroll in an occupational therapy (OT) lifestyle redesign intervention focused on diabetes management. The intervention includes approximately 8 one-hour OT sessions over 4 months.
干预措施: Lifestyle Redesign (Behavioral)
结局指标
主要结局
Difference in the daily rate of change of Glycated hemoglobin (HbA1C) during the year prior to baseline, compared to the period from baseline to post-intervention
时间窗: all measures taken from one year prior to baseline, to immediately post-intervention (an average of 4 months)
Measure of average blood glucose concentration over approximately the previous 12 weeks. HbA1C is measured periodically, as prescribed by study-independent provider.
次要结局
- Change from baseline in Medication adherence scale at post-intervention(Baseline, an average of 4 months)
- Acceptability(Months 11-12)
- Change from baseline in Audit of Diabetes-Dependent Quality of Life (ADD-QoL) at post-intervention(Baseline, an average of 4 months)
- Appropriateness(Months 0-2, 3-10, and 11-12)
- Difference in the daily rate of change of Patient Health Questionnaire-9 (PHQ-9) during the year prior to baseline, compared to the period from baseline to post-intervention(all measures taken from one year prior to baseline, to immediately post-intervention (an average of 4 months))
- Change from baseline in Summary of Diabetes Self-Care Activities (SDSCA) at post-intervention(Baseline, an average of 4 months)
- Change from baseline in Appraisal of Diabetes Scale at post-intervention(Baseline, an average of 4 months)
- Feasibility(Months 0-2, and 11-12)
- Timeliness(Months 11-12)
- Change from baseline RAND 20-Item Short Form Survey (SF-20) at post-intervention(Baseline, an average of 4 months)
- Fidelity(Months 0-2, 3-10, and 11-12)
- Efficiency(Months 0-2 and 11-12)
研究者
Beth Pyatak
Assistant Professor
University of Southern California