Primary Care Based Integrated Community Care Team Intervention (PACE-It)

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

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.

Study Overview

• Status: Terminated
• Conditions: Diabetes Mellitus, Type 2; Diabetes Mellitus; Diabetes; Diabetes type2
• Intervention / Treatment: Other: PACE-It mobile application

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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 440080
    • SingHealth Polyclinics - Marine Parade, 80 Marine Parade Central, #01-792

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention arm; Providers use PACE-It mobile application as a care co-ordination platform	Other: PACE-It mobile application; Care co-ordination platform
NO_INTERVENTION: Usual care; Providers use usual modes of communication (e.g., phone calls, emails)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: SingHealth Polyclinics
• Collaborators: Agency for Integrated Care, Singapore; Ministry of Health, Singapore; SingHealth Regional Health System
• Investigators: Principal Investigator: Sinead Zhen Wang, Dr, SingHealth Polyclinics

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 7, 2020
• Primary Completion (ACTUAL): February 8, 2022
• Study Completion (ACTUAL): February 8, 2022

Study Registration Dates

• First Submitted: March 25, 2021
• First Submitted That Met QC Criteria: March 25, 2021
• First Posted (ACTUAL): March 26, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 28, 2022
• Last Update Submitted That Met QC Criteria: April 21, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2020/2202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No