Primary Care Based Integrated Community Care Team Intervention

Diabetes Mellitus, Type 2 Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04819256
• Other study ID #: 2020/2202
• Status: Terminated
• Phase: N/A
• Start date: December 7, 2020
• Est. completion date: February 8, 2022

Study information

• Verified date: April 2022
• Source: SingHealth Polyclinics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: February 8, 2022
• Est. primary completion date: February 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes type2

Intervention

Other:
• PACE-It mobile application
Care co-ordination platform

Locations

Country	Name	City	State
Singapore	SingHealth Polyclinics - Marine Parade, 80 Marine Parade Central, #01-792	Singapore

Sponsors (4)

Lead Sponsor	Collaborator
SingHealth Polyclinics	Agency for Integrated Care, Singapore, Ministry of Health, Singapore, SingHealth Regional Health System

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	Glycemic control	1 year
Secondary	Blood pressure	Systolic and diastolic blood pressure (mmHg)	1 year
Secondary	LDL-cholesterol	Low-density lipoprotein cholesterol	1 year
Secondary	Patient activation measure (PAM)	Patient's activation levels	1 year
Secondary	Medication adherence measure (MARS-5)	Patient's adherence to medication	1 year
Secondary	EQ-5D-5L	Quality of life	1 year
Secondary	Patient satisfaction	Qualitative survey and interview	1 year
Secondary	Provider's satisfaction	Qualitative survey and interview	2 years
Secondary	Cost-effectiveness	Cost-effectiveness of care model	2 years
Secondary	Implementation of care model	Factors affecting implementation of care model	2 years