NCT04819256

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable diabetes

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 7, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 26, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2022

Completed
Last Updated

April 28, 2022

Status Verified

April 1, 2022

Enrollment Period

1.2 years

First QC Date

March 25, 2021

Last Update Submit

April 21, 2022

Conditions

DiabetesDiabetes MellitusDiabetes Mellitus, Type 2Diabetes type2

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    Glycemic control

    1 year

Secondary Outcomes (9)

  • Blood pressure

    1 year

  • LDL-cholesterol

    1 year

  • Patient activation measure (PAM)

    1 year

  • Medication adherence measure (MARS-5)

    1 year

  • EQ-5D-5L

    1 year

  • +4 more secondary outcomes

Study Arms (2)

Intervention arm

EXPERIMENTAL

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

Other: PACE-It mobile application

Usual care

NO INTERVENTION

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

Interventions

PACE-It mobile applicationOTHER

Care co-ordination platform

Intervention arm

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Living within the designated geographical zone
  • 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)
  • +5 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Singapore, 440080, Singapore

Location

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Sinead Zhen Wang, Dr

    SingHealth Polyclinics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2021

First Posted

March 26, 2021

Study Start

December 7, 2020

Primary Completion

February 8, 2022

Study Completion

February 8, 2022

Last Updated

April 28, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)