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

Primary Purpose

Diabetes, Diabetes Mellitus, Diabetes Mellitus, Type 2

Status
Terminated
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
PACE-It mobile application
Sponsored by
SingHealth Polyclinics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention arm

Usual care

Arm Description

Providers use PACE-It mobile application as a care co-ordination platform

Providers use usual modes of communication (e.g., phone calls, emails)

Outcomes

Primary Outcome Measures

HbA1c
Glycemic control

Secondary Outcome Measures

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

Full Information

First Posted
March 25, 2021
Last Updated
April 21, 2022
Sponsor
SingHealth Polyclinics
Collaborators
Ministry of Health, Singapore, Agency for Integrated Care, Singapore, SingHealth Regional Health System
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1. Study Identification

Unique Protocol Identification Number
NCT04819256
Brief Title
Primary Care Based Integrated Community Care Team Intervention
Acronym
PACE-It
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Terminated
Why Stopped
Funding diverted to expansion of programme and PACE-It App
Study Start Date
December 7, 2020 (Actual)
Primary Completion Date
February 8, 2022 (Actual)
Study Completion Date
February 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SingHealth Polyclinics
Collaborators
Ministry of Health, Singapore, Agency for Integrated Care, Singapore, SingHealth Regional Health System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Diabetes Mellitus, Type 2, Diabetes type2

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
Providers use PACE-It mobile application as a care co-ordination platform
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Providers use usual modes of communication (e.g., phone calls, emails)
Intervention Type
Other
Intervention Name(s)
PACE-It mobile application
Intervention Description
Care co-ordination platform
Primary Outcome Measure Information:
Title
HbA1c
Description
Glycemic control
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Blood pressure
Description
Systolic and diastolic blood pressure (mmHg)
Time Frame
1 year
Title
LDL-cholesterol
Description
Low-density lipoprotein cholesterol
Time Frame
1 year
Title
Patient activation measure (PAM)
Description
Patient's activation levels
Time Frame
1 year
Title
Medication adherence measure (MARS-5)
Description
Patient's adherence to medication
Time Frame
1 year
Title
EQ-5D-5L
Description
Quality of life
Time Frame
1 year
Title
Patient satisfaction
Description
Qualitative survey and interview
Time Frame
1 year
Title
Provider's satisfaction
Description
Qualitative survey and interview
Time Frame
2 years
Title
Cost-effectiveness
Description
Cost-effectiveness of care model
Time Frame
2 years
Title
Implementation of care model
Description
Factors affecting implementation of care model
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sinead Zhen Wang, Dr
Organizational Affiliation
SingHealth Polyclinics
Official's Role
Principal Investigator
Facility Information:
Facility Name
SingHealth Polyclinics - Marine Parade, 80 Marine Parade Central, #01-792
City
Singapore
ZIP/Postal Code
440080
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No

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Primary Care Based Integrated Community Care Team Intervention

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