Collaborative Care Model on Type 2 Diabetic Patients

March 2, 2021 updated by: Joyce Lee, PharmD, National University of Singapore

The Impact of Collaborative Care Model in the Management of Primary Care Patients With Type 2 Diabetes Mellitus in Singapore

The purpose of this study is to determine the effectiveness of the collaborative care model in Singapore in which clinical pharmacists, nurses and dietitians are active participants who collaborate with physicians in caring for patients with Type 2 diabetes mellitus (DM).Since DM is a cardiovascular risk equivalent, co-morbidities such as hypertension (HTN) and dyslipidaemia (DLP) will also be evaluated to assess the holistic care provided for the investigator's patients afflicted with these top chronic diseases in Singapore.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Specifically, this study aims to evaluate the effectiveness of an integrated collaborative care model comprising of a healthcare team (physician, clinical pharmacist, nurse, and/or dietitian) compared to the usual or conventional healthcare model (physician-centered care) mainly in the clinical, humanistic and economic outcomes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
255

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore
        • Chua Chu Kang Polyclinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged ≥ 21 years with Type 2 DM (HbA1c > 7%) and polypharmacy (≥ 5 medications) will be eligible for this study.

Exclusion Criteria:

  • Patients with Type 1 DM or who are unable to communicate independently in English, Chinese or Malay will be excluded from this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
NO_INTERVENTION: Control
Patients randomly assigned to the control arm will receive the usual or conventional care not interfered by the study team.
EXPERIMENTAL: Intervention
The intervention arm will receive collaborative care from a team of healthcare professionals that consists of pharmacist, physicians, nurses and dietitians. Patients in the intervention group will also receive clinical interventions carried out by the pharmacist.
Behavioral: collaborative care
The intervention arm will receive collaborative care from a team of healthcare professionals that consists of pharmacist, physicians, nurses and dietitians. Patients in the intervention group will also receive clinical interventions carried out by the pharmacist.nurses and dietitians as well as a pharmacist.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline Body mass index (BMI) at 6-month
Time Frame: baseline and 6-month
Change of BMI in kg/m^2
baseline and 6-month
Change from baseline Glycated Haemoglobin (HbA1c) at 6-month
Time Frame: baseline and 6-month
Change of HbA1c in %
baseline and 6-month
Changes from baseline Systolic Blood Pressure (SBP) at 6-month
Time Frame: baseline and 6-month
Change of SBP in mmHg
baseline and 6-month
Change from baseline Low-density lipoprotein (LDL) at 6-month
Time Frame: baseline and 6-month
Change of LDL in mg/dL
baseline and 6-month
Change from baseline High-density lipoprotein (HDL) at 6-month
Time Frame: baseline and 6-month
Change of HDL in mg/dL
baseline and 6-month
Change from baseline Total cholesterol (TC) at 6-month
Time Frame: baseline and 6-month
Change of TC in mg/dL
baseline and 6-month
Change from baseline Glycerides (TG) at 6-month
Time Frame: baseline and 6-month
Changes of TG in mg/dL
baseline and 6-month
Incidence of hypoglycaemia
Time Frame: 6-month
Incidence of hypoglycaemia
6-month
Change from baseline Body mass index (BMI) at 12 months
Time Frame: 12-month
Change BMI in kg/m^2
12-month
Change from baseline Glycated Haemoglobin (HbA1c) at 12-month
Time Frame: 12-month
Changes of HbA1c in %
12-month
Change from baseline Systolic Blood Pressure (SBP) at 12-month
Time Frame: 12-month
Change of SBP in mmHg
12-month
Change from baseline Low-density lipoprotein (LDL) at 12-month
Time Frame: 12-month
Changes of LDL in mg/dL
12-month
Change from baseline High-density lipoprotein (HDL) at 12-month
Time Frame: 12-month
Changes of HDL in mg/dL
12-month
Change from baseline Total cholesterol (TC) at 12-month
Time Frame: 12-month
Changes of TC in mg/dL
12-month
Change from baseline Glycerides (TG) at 12-month
Time Frame: 12-month
Changes of TG in mg/dL
12-month
Incidence of hypoglycaemia
Time Frame: 12-month
Incidence of hypoglycaemia
12-month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The 5-level EQ-5D version (5Q-5D-5L)
Time Frame: baseline
5Q-5D-5L is a questionnaire containing 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) with 5 levels (no problems, slight problems, moderate problems, severe problems and extreme problems) for the patients to indicate their health stage.
baseline
The 5-level EQ-5D version (5Q-5D-5L)
Time Frame: 6-month
5Q-5D-5L is a questionnaire containing 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) with 5 levels (no problems, slight problems, moderate problems, severe problems and extreme problems) for the patients to indicate their health stage.
6-month
The 5-level EQ-5D version (5Q-5D-5L)
Time Frame: 12-month
5Q-5D-5L is a questionnaire containing 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) with 5 levels (no problems, slight problems, moderate problems, severe problems and extreme problems) for the patients to indicate their health stage.
12-month
Audit of Diabetes Dependent Quality of Life (ADDQoL)
Time Frame: baseline
The ADDQoL is a 19-item questionnaire measuring the effects of diabetes and its treatment on individuals' quality of life.
baseline
Audit of Diabetes Dependent Quality of Life (ADDQoL)
Time Frame: 6-month
The ADDQoL is a 19-item questionnaire measuring the effects of diabetes and its treatment on individuals' quality of life.
6-month
Audit of Diabetes Dependent Quality of Life (ADDQoL)
Time Frame: 12-month
The ADDQoL is a 19-item questionnaire measuring the effects of diabetes and its treatment on individuals' quality of life.
12-month
The Problem Area in Diabetes (PAID)
Time Frame: baseline
The PAID is a valid and reliable 20-item questionnaire measuring diabetes-related distress with a five-point Likert scale that ranges from 0 (not a problem) to 4 (serious problem).
baseline
The Problem Area in Diabetes (PAID)
Time Frame: 6-month
The PAID is a valid and reliable 20-item questionnaire measuring diabetes-related distress with a five-point Likert scale that ranges from 0 (not a problem) to 4 (serious problem).
6-month
The Problem Area in Diabetes (PAID)
Time Frame: 12-month
The PAID is a valid and reliable 20-item questionnaire measuring diabetes-related distress with a five-point Likert scale that ranges from 0 (not a problem) to 4 (serious problem).
12-month
Summary of Diabetes Self-Care Activities (SDSCA)
Time Frame: baseline
The SDSCA measure is a brief self-report questionnaire of diabetes self-management that includes 14 items assessing the following aspects of the diabetes regimen: general dies, specific diet, exercise, blood-glucose testing, foot care, and smoking.
baseline
Summary of Diabetes Self-Care Activities (SDSCA)
Time Frame: 6-month
The SDSCA measure is a brief self-report questionnaire of diabetes self-management that includes 14 items assessing the following aspects of the diabetes regimen: general dies, specific diet, exercise, blood-glucose testing, foot care, and smoking.
6-month
Summary of Diabetes Self-Care Activities (SDSCA)
Time Frame: 12-month
The SDSCA measure is a brief self-report questionnaire of diabetes self-management that includes 14 items assessing the following aspects of the diabetes regimen: general dies, specific diet, exercise, blood-glucose testing, foot care, and smoking.
12-month
Self-report Hypoglycaemia Question
Time Frame: baseline
It is 5-item questionnaire for the patients with diabetes to self-assess their symptoms of hypoglycaemia.
baseline
Self-report Hypoglycaemia Question
Time Frame: 6-month
It is 5-item questionnaire for the patients with diabetes to self-assess their symptoms of hypoglycaemia.
6-month
Self-report Hypoglycaemia Question
Time Frame: 12-month
It is 5-item questionnaire for the patients with diabetes to self-assess their symptoms of hypoglycaemia.
12-month
Work Productivity and Activity Impairment questionnaire, General Health version (WPAI-GH)
Time Frame: 6-month
The WPAI-GH is a 6-item questionnaire measuring absenteeism, presenteeism, overall work productivity loss, and daily activity impairment with a 10-point scale that range from 0 (no effect on daily activities) to 10 (serious effect on daily activities).
6-month
Work Productivity and Activity Impairment questionnaire, General Health version (WPAI-GH)
Time Frame: 12-month
The WPAI-GH is a 6-item questionnaire measuring absenteeism, presenteeism, overall work productivity loss, and daily activity impairment with a 10-point scale that range from 0 (no effect on daily activities) to 10 (serious effect on daily activities).
12-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National University of Singapore

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wei Yan Tan, National Healthcare Group Pharmacy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 11, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 14, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 2, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 3, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017/01191

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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