Primary Care Based Integrated Community Care Team Intervention
- Conditions
- Diabetes type2DiabetesDiabetes MellitusDiabetes Mellitus, Type 2
- Interventions
- Other: PACE-It mobile application
- Registration Number
- NCT04819256
- Lead Sponsor
- SingHealth Polyclinics
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 41
-
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
-
Functional
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention arm PACE-It mobile application Providers use PACE-It mobile application as a care co-ordination platform
- Primary Outcome Measures
Name Time Method HbA1c 1 year Glycemic control
- Secondary Outcome Measures
Name Time Method Provider's satisfaction 2 years Qualitative survey and interview
Blood pressure 1 year Systolic and diastolic blood pressure (mmHg)
LDL-cholesterol 1 year Low-density lipoprotein cholesterol
Cost-effectiveness 2 years Cost-effectiveness of care model
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
Patient satisfaction 1 year Qualitative survey and interview
Implementation of care model 2 years Factors affecting implementation of care model
Trial Locations
- Locations (1)
SingHealth Polyclinics - Marine Parade, 80 Marine Parade Central, #01-792
🇸🇬Singapore, Singapore