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Completed

NCT Number: NCT03553862

Collaborative Care Model on Type 2 Diabetic Patients

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.

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Key information

Conditions

Type2 Diabetes

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chua Chu Kang Polyclinic

Singapore

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

collaborative care

Behavioral

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 outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

National University of Singapore

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 12, 2018
Registry last updated
Mar 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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