PACE-It: Primary Care Based Integrated Community Care Team Intervention

Sponsor
SingHealth Polyclinics (Other)
Overall Status
Terminated
CT.gov ID
NCT04819256
Collaborator
Ministry of Health, Singapore (Other), Agency for Integrated Care, Singapore (Other), SingHealth Regional Health System (Other)
41
1
2
14.1
2.9

Study Details

Study Description

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

  1. 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.
Condition or Disease Intervention/Treatment Phase
  • Other: PACE-It mobile application
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
41 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Dec 7, 2020
Actual Primary Completion Date :
Feb 8, 2022
Actual Study Completion Date :
Feb 8, 2022

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. HbA1c [1 year]

    Glycemic control

Secondary Outcome Measures

  1. Blood pressure [1 year]

    Systolic and diastolic blood pressure (mmHg)

  2. LDL-cholesterol [1 year]

    Low-density lipoprotein cholesterol

  3. Patient activation measure (PAM) [1 year]

    Patient's activation levels

  4. Medication adherence measure (MARS-5) [1 year]

    Patient's adherence to medication

  5. EQ-5D-5L [1 year]

    Quality of life

  6. Patient satisfaction [1 year]

    Qualitative survey and interview

  7. Provider's satisfaction [2 years]

    Qualitative survey and interview

  8. Cost-effectiveness [2 years]

    Cost-effectiveness of care model

  9. Implementation of care model [2 years]

    Factors affecting implementation of care model

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts 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

  3. chronic kidney impairment stage 3 and above, or diabetes overt nephropathy,

  4. ischaemic heart disease, or congestive cardiac failure,

  5. peripheral arterial disease, or diabetes foot/ diabetes foot-related complications,

  6. diabetic retinopathy/ treatment for retinopathy, and

  7. 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
  1. 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
  1. Functional

  2. Clinical Frailty Score ≥ 4, requiring help in instrumental activities of daily living (iADL)

  3. Requires assistance in ADL or iADL

  4. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 SingHealth Polyclinics - Marine Parade, 80 Marine Parade Central, #01-792 Singapore Singapore 440080

Sponsors and Collaborators

  • SingHealth Polyclinics
  • Ministry of Health, Singapore
  • Agency for Integrated Care, Singapore
  • SingHealth Regional Health System

Investigators

  • Principal Investigator: Sinead Zhen Wang, Dr, SingHealth Polyclinics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
SingHealth Polyclinics
ClinicalTrials.gov Identifier:
NCT04819256
Other Study ID Numbers:
  • 2020/2202
First Posted:
Mar 26, 2021
Last Update Posted:
Apr 28, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 28, 2022