MedPath

Primary Care Based Integrated Community Care Team Intervention

Not Applicable
Terminated
Conditions
Diabetes type2
Diabetes
Diabetes Mellitus
Diabetes 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
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

Read More
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
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Intervention armPACE-It mobile applicationProviders use PACE-It mobile application as a care co-ordination platform
Primary Outcome Measures
NameTimeMethod
HbA1c1 year

Glycemic control

Secondary Outcome Measures
NameTimeMethod
Provider's satisfaction2 years

Qualitative survey and interview

Blood pressure1 year

Systolic and diastolic blood pressure (mmHg)

LDL-cholesterol1 year

Low-density lipoprotein cholesterol

Cost-effectiveness2 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-5L1 year

Quality of life

Patient satisfaction1 year

Qualitative survey and interview

Implementation of care model2 years

Factors affecting implementation of care model

Trial Locations

Locations (1)

SingHealth Polyclinics - Marine Parade, 80 Marine Parade Central, #01-792

🇸🇬

Singapore, Singapore

© Copyright 2025. All Rights Reserved by MedPath