PACE-It Study : Primary Care Based Integrated Community Care Team Intervention to Improve the Health Outcomes of Patients Living With Diabetes and Complex Needs - a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
PACE-It study is a non-blinded, mix-method randomized controlled trial within a single site. This study aims to test the feasibility of implementing a complex intervention comprising of a) a Primary Care Based integrated community care team delivery of person centered care, b) supported by a care co-ordination platform using a mobile application and its effectiveness in improving the glycemic control of patients living with Diabetes and have complex needs.
详细描述
PACE-It study aims to test the feasibility of implementing a complex intervention comprising of a) a Primary Care Based Community Care Team delivery of person centered care b) supported by a care co-ordination platform using a mobile application and its effectiveness in improving the glycemic control of patients living with Diabetes and complex needs.
This is a non-blinded, mix-method randomised controlled trial within the Marine Parade Community. The primary outcome will be glycemic control measure by the Glycated Haemoglobin (HbA1c). Secondary outcomes include blood pressure, LDL-cholesterol, Patient Activation Measure, Medication Adherence and Quality of Life. Data on patient and provider satisfaction and implementation process will be collected by the Qualitative method.
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
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Living within the designated geographical zone
- •50 years and above
- •Satisfy the Medical Criteria below:
- •Diabetes with HbA1c ≥ 9% (within past 6 months), and
- •At least 1 complication
- •chronic kidney impairment stage 3 and above, or diabetes overt nephropathy,
- •ischaemic heart disease, or congestive cardiac failure,
- •peripheral arterial disease, or diabetes foot/ diabetes foot-related complications,
- •diabetic retinopathy/ treatment for retinopathy, and
- •stroke, or transient ischaemic attack
- •Satisfy at least 2 conditions in the psycho-social, functional or activation domain of which 1 criteria must be from the psycho-social domain:
- •Psycho-social issues
- •a. Lack of care giver support i. No care-giver (when indicated) ii. Care-giver skills gap/ stress iii. Inability of copy when patient is the care-giver b. Difficult relationships (family/ workplace/ social network) c. Social isolation/ lack of social connectivity i. Lives alone ii. Lack of social network support d. Financial i. Financial difficulty/ insecurity ii. Housing/ shelter issues iii. Poor money management
- •Clinical Frailty Score ≥ 4, requiring help in instrumental activities of daily living (iADL)
- •Requires assistance in ADL or iADL
- •Activation a. Lack of ability to manage health - disengaged or overwhelmed i. Anxiety or disease-related distress ii. Confusion or lack of understanding of care plans iii. Non-adherence to medications/ follow up
- •Patient gives consent to participate
- •For patients who may be seeing a Primary Care Physician (PCP) outside of the polyclinic for chronic disease management and where the PCP has indicated consent to co-manage the patient with the PACE-It team including the polyclinic physician
- •Patient must be willing to receive care in the polyclinic
排除标准
- •Patients who are on follow up with Primary Care Physicians or General Practitioners elsewhere for management of their chronic conditions and they do not consent to co-managing patient with the PACE-It team
- •Patients who have severe cognitive impairment, depression or psychiatric conditions that interfere with the ability to engage with the healthcare team
- •Patients who are (i) not community ambulant or (ii) bed bound
- •Patients with terminal illness
- •Patients who have are in other programs or research studies
- •Patients who do not give consent
研究组 & 干预措施
Intervention arm
Providers use PACE-It mobile application as a care co-ordination platform
干预措施: PACE-It mobile application (Other)
Usual care
Providers use usual modes of communication (e.g., phone calls, emails)
结局指标
主要结局
HbA1c
时间窗: 1 year
Glycemic control
次要结局
- Patient satisfaction(1 year)
- Provider's satisfaction(2 years)
- Blood pressure(1 year)
- LDL-cholesterol(1 year)
- Cost-effectiveness(2 years)
- Patient activation measure (PAM)(1 year)
- Medication adherence measure (MARS-5)(1 year)
- EQ-5D-5L(1 year)
- Implementation of care model(2 years)