Primary Care Based Integrated Community Care Team Intervention

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Diabetes, Diabetes Mellitus, Diabetes Mellitus, Type 2, Diabetes type2

Intervention / Treatment
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* Other: PACE-It mobile application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>Providers use PACE-It mobile application as a care co-ordination platform | Other: PACE-It mobile application<br>* Care co-ordination platform<br>|
| No Intervention: Usual care<br>Providers use usual modes of communication (e.g., phone calls, emails) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | Glycemic control | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Systolic and diastolic blood pressure (mmHg) | 1 year | 
| LDL-cholesterol | Low-density lipoprotein cholesterol | 1 year | 
| Patient activation measure (PAM) | Patient's activation levels | 1 year | 
| Medication adherence measure (MARS-5) | Patient's adherence to medication | 1 year | 
| EQ-5D-5L | Quality of life | 1 year | 
| Patient satisfaction | Qualitative survey and interview | 1 year | 
| Provider's satisfaction | Qualitative survey and interview | 2 years | 
| Cost-effectiveness | Cost-effectiveness of care model | 2 years | 
| Implementation of care model | Factors affecting implementation of care model | 2 years |