DiabetesPACE-ItNCT04819256

Primary Care Based Integrated Community Care Team Intervention

A study testing PACE-It mobile application in people with Diabetes and Diabetes Mellitus, run by SingHealth Polyclinics at 1 site in Singapore.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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… Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: Diabetes, Diabetes Mellitus, Diabetes Mellitus, Type 2
What is being tested?: PACE-It mobile application
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 41 participants
Where: 1 siteSingapore
Study dates: 7 Dec 2020to 8 Feb 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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,

Show all 20Show fewer

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
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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Singapore1 site

SingHealth Polyclinics - Marine Parade, 80 Marine Parade Central, #01-792
Singapore, 440080

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About this study

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

Read the 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.

Conditions: Diabetes, Diabetes Mellitus, Diabetes Mellitus, Type 2, Diabetes type2
Being tested: PACE-It mobile application
Medical subject headings: Diabetes Mellitus, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PACE-It mobile applicationOther
Care co-ordination platform

Study groups in NCT04819256
Study group	Role	What they receive
Intervention arm	Experimental	Providers use PACE-It mobile application as a care co-ordination platform Receives: Other: PACE-It mobile application
Usual care	No intervention	Providers use usual modes of communication (e.g., phone calls, emails)

What is being measured

The primary outcome is the main question the study is designed to answer.

HbA1c
Glycemic control
Measured: 1 year

Secondary outcomes (9)

Blood pressure
Systolic and diastolic blood pressure (mmHg)
Measured: 1 year
LDL-cholesterol
Low-density lipoprotein cholesterol
Measured: 1 year
Patient activation measure (PAM)
Patient's activation levels
Measured: 1 year
Medication adherence measure (MARS-5)
Patient's adherence to medication
Measured: 1 year
EQ-5D-5L
Quality of life
Measured: 1 year
Patient satisfaction
Qualitative survey and interview
Measured: 1 year
Provider's satisfaction
Qualitative survey and interview
Measured: 2 years
Cost-effectiveness
Cost-effectiveness of care model
Measured: 2 years
Implementation of care model
Factors affecting implementation of care model
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Dec 20208 Feb 2022

First posted26 Mar 2021
Study start7 Dec 2020
Primary completion8 Feb 2022
Study completion8 Feb 2022

Why it stopped: Funding diverted to expansion of programme and PACE-It App

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for DiabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04819256
Sponsor's protocol ID: 2020/2202
Acronym: PACE-It
Status last verified: Apr 2022
First submitted: 25 Mar 2021
Last updated: 28 Apr 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04819256
Acronym / sponsor ID: PACE-It / 2020/2202
Conditions: Diabetes, Diabetes Mellitus, Diabetes Mellitus, Type 2, Diabetes type2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Funding diverted to expansion of programme and PACE-It App
Enrolment: 41 participants (actual)
Lead sponsor: SingHealth PolyclinicsUniversity, hospital or other
Collaborators: Ministry of Health, Singapore, Agency for Integrated Care, Singapore, SingHealth Regional Health System
Study start: 7 Dec 2020 (actual)
Primary completion: 8 Feb 2022 (actual)
Study completion: 8 Feb 2022 (actual)
First posted: 26 Mar 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Intervention arm	Experimental	Other: PACE-It mobile applicationProviders use PACE-It mobile application as a care co-ordination platform
Usual care	No intervention	–Providers use usual modes of communication (e.g., phone calls, emails)

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (20 listed)

Living within the designated geographical zone
50 years and above
Satisfy the Medical Criteria below:
Satisfy at least 2 conditions in the psycho-social, functional or activation domain of which 1 criteria must be from the psycho-social domain:
Patient gives consent to participate

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PACE-It mobile applicationCare co-ordination platform	Other	Intervention arm

Primary outcome

HbA1c
Time frame: 1 year
Glycemic control

9 secondary outcomes

Blood pressure
Time frame: 1 year
LDL-cholesterol
Time frame: 1 year
Patient activation measure (PAM)
Time frame: 1 year
Medication adherence measure (MARS-5)
Time frame: 1 year
EQ-5D-5L
Time frame: 1 year
Patient satisfaction
Time frame: 1 year
Provider's satisfaction
Time frame: 2 years
Cost-effectiveness
Time frame: 2 years
Implementation of care model
Time frame: 2 years

Results and safety

The study was stopped early (reason given: Funding diverted to expansion of programme and PACE-It App). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sinead Zhen Wang, Dr principal investigator

SingHealth Polyclinics

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing PACE-It mobile application in people with Diabetes and Diabetes Mellitus, run by SingHealth Polyclinics at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Funding diverted to expansion of programme and PACE-It App). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04819256.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022; AzTrials last refreshed its copy on 30 Oct 2026.