Diabetes, Diabetes Mellitus, Diabetes Mellitus, Type 2, Diabetes type2
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERPACE-It mobile application
Care co-ordination platform
Sponsors
Ministry of Health, Singapore
Agency for Integrated Care, Singapore
SingHealth Regional Health System
SingHealth Polyclinics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Living within the designated geographical zone * 50 years and above * Satisfy the Medical Criteria below: 1. Diabetes with HbA1c ≥ 9% (within past 6 months), and 2. At least 1 complication 1. chronic kidney impairment stage 3 and above, or diabetes overt nephropathy, 2. ischaemic heart disease, or congestive cardiac failure, 3. peripheral arterial disease, or diabetes foot/ diabetes foot-related complications, 4. diabetic retinopathy/ treatment for retinopathy, and 5. 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: 1. 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 2. Functional 1. Clinical Frailty Score ≥ 4, requiring help in instrumental activities of daily living (iADL) 2. Requires assistance in ADL or iADL 3. 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 1 year | Glycemic control |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient activation measure (PAM) | 1 year | Patient's activation levels |
| Medication adherence measure (MARS-5) | 1 year | Patient's adherence to medication |
| EQ-5D-5L | 1 year | Quality of life |
| Blood pressure | 1 year | Systolic and diastolic blood pressure (mmHg) |
| LDL-cholesterol | 1 year | Low-density lipoprotein cholesterol |
| Provider's satisfaction | 2 years | Qualitative survey and interview |
| Cost-effectiveness | 2 years | Cost-effectiveness of care model |
| Implementation of care model | 2 years | Factors affecting implementation of care model |
| Patient satisfaction | 1 year | Qualitative survey and interview |
Countries
Singapore
Outcome results
None listed