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Collaborative Care Model on Type 2 Diabetic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03553862
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
Joyce Lee, National University, Singapore

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type2 Diabetes Behavioral: collaborative care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: The Impact of Collaborative Care Model in the Management of Primary Care Patients With Type 2 Diabetes Mellitus in Singapore
Actual Study Start Date : May 11, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Change from baseline Body mass index (BMI) at 6-month [ Time Frame: baseline and 6-month ]
    Change of BMI in kg/m^2

  2. Change from baseline Glycated Haemoglobin (HbA1c) at 6-month [ Time Frame: baseline and 6-month ]
    Change of HbA1c in %

  3. Changes from baseline Systolic Blood Pressure (SBP) at 6-month [ Time Frame: baseline and 6-month ]
    Change of SBP in mmHg

  4. Change from baseline Low-density lipoprotein (LDL) at 6-month [ Time Frame: baseline and 6-month ]
    Change of LDL in mg/dL

  5. Change from baseline High-density lipoprotein (HDL) at 6-month [ Time Frame: baseline and 6-month ]
    Change of HDL in mg/dL

  6. Change from baseline Total cholesterol (TC) at 6-month [ Time Frame: baseline and 6-month ]
    Change of TC in mg/dL

  7. Change from baseline Glycerides (TG) at 6-month [ Time Frame: baseline and 6-month ]
    Changes of TG in mg/dL

  8. Incidence of hypoglycaemia [ Time Frame: 6-month ]
    Incidence of hypoglycaemia

  9. Change from baseline Body mass index (BMI) at 12 months [ Time Frame: 12-month ]
    Change BMI in kg/m^2

  10. Change from baseline Glycated Haemoglobin (HbA1c) at 12-month [ Time Frame: 12-month ]
    Changes of HbA1c in %

  11. Change from baseline Systolic Blood Pressure (SBP) at 12-month [ Time Frame: 12-month ]
    Change of SBP in mmHg

  12. Change from baseline Low-density lipoprotein (LDL) at 12-month [ Time Frame: 12-month ]
    Changes of LDL in mg/dL

  13. Change from baseline High-density lipoprotein (HDL) at 12-month [ Time Frame: 12-month ]
    Changes of HDL in mg/dL

  14. Change from baseline Total cholesterol (TC) at 12-month [ Time Frame: 12-month ]
    Changes of TC in mg/dL

  15. Change from baseline Glycerides (TG) at 12-month [ Time Frame: 12-month ]
    Changes of TG in mg/dL

  16. Incidence of hypoglycaemia [ Time Frame: 12-month ]
    Incidence of hypoglycaemia


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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. 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.

  7. 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).

  8. 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).

  9. 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).

  10. 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.

  11. 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.

  12. 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.

  13. Self-report Hypoglycaemia Question [ Time Frame: baseline ]
    It is 5-item questionnaire for the patients with diabetes to self-assess their symptoms of hypoglycaemia.

  14. 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.

  15. 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.

  16. 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).

  17. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03553862


Contacts
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Contact: Yingqi Xu (65) 98210436 e0269786@u.nus.edu

Locations
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Singapore
Chua Chu Kang Polyclinic Recruiting
Singapore, Singapore
Contact: Keith Tsou, Doctor    (65) 6496 6773    keith_tsou@nuhs.edu.sg   
Sponsors and Collaborators
National University, Singapore
Investigators
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Principal Investigator: Wei Yan Tan National Healthcare Group Pharmacy
  Study Documents (Full-Text)

Documents provided by Joyce Lee, National University, Singapore:
Study Protocol  [PDF] March 6, 2018


Publications:
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Responsible Party: Joyce Lee, Principle Investigator, National University, Singapore
ClinicalTrials.gov Identifier: NCT03553862    
Other Study ID Numbers: 2017/01191
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases