Clinical trial NCT04819256: Primary Care Based Integrated Community Care Team Intervention
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
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes type2
Lead sponsor: SingHealth Polyclinics
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Singapore
name: Agency for Integrated Care, Singapore
name: SingHealth Regional Health System
First posted: 2021-03-26
Enrollment: 41
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: HbA1c
timeFrame: 1 year
Secondary outcomes:
measure: Blood pressure
timeFrame: 1 year
measure: LDL-cholesterol
timeFrame: 1 year
measure: Patient activation measure (PAM)
timeFrame: 1 year
measure: Medication adherence measure (MARS-5)
timeFrame: 1 year
measure: EQ-5D-5L
timeFrame: 1 year
measure: Patient satisfaction
timeFrame: 1 year
measure: Provider's satisfaction
timeFrame: 2 years
measure: Cost-effectiveness
timeFrame: 2 years
measure: Implementation of care model
timeFrame: 2 years
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: SingHealth Polyclinics - Marine Parade, 80 Marine Parade Central, #01-792
Study officials:
affiliation: SingHealth Polyclinics
name: Sinead Zhen Wang, Dr
role: PRINCIPAL_INVESTIGATOR
References: