Impact of Community Pharmacist-Involved Collaborative Care Model for the Management of Type 2 Diabetes Mellitus

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

The Impact of Community Pharmacist-Involved Collaborative Care in the Management of Primary Care Patients With Type 2 Diabetes Mellitus in Singapore (IMPACT-C)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03531944
• Other study ID #: H-18-019
• Status: Completed
• Phase: N/A
• Start date: June 6, 2018
• Est. completion date: March 31, 2020

Study information

• Verified date: March 2021
• Source: National University, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background: In Singapore, the prevalence of diabetes mellitus was approximately 12.8% in 2014 and the prevalence was projected to rise to 22.7% in 2035. In view of the complexity of diabetes management, collaborative efforts by nurses and other allied health professionals such as dietitians and pharmacists have shown to play a significant role in improving clinical care of individuals with diabetes. Currently in Singapore, the effectiveness of the collaborative care model has only been evaluated prospectively in the primary and tertiary care settings involving clinical pharmacists. The impact of the unique, synergistic roles of community pharmacists with family physician on the clinical, humanistic and economic outcomes have yet to be elucidated.

Aims: This study aims to evaluate the clinical, humanistic, and economic outcomes of a community pharmacist-involved collaborative care model in the management of individuals with type 2 diabetes mellitus.

Hypothesis: Incorporating community pharmacist into the care model with family physician and nurse can improve the clinical, humanistic, and economic outcomes of individuals with type 2 diabetes mellitus.

Methods: This study is a prospective, open label, parallel arm, randomized controlled trial. The study will be conducted over 6 months at a family medicine clinic in Singapore. Individuals aged 21 years and above, diagnosed with type 2 diabetes (HbA1c > 7.0%) and taking 5 or more chronic medications will be eligible. Individuals with Type 1 diabetes or who are unable to communicate independently in English, Mandarin or Malay will be excluded from this study. The participants will be randomly assigned to 2 groups using a random number generator or an equivalent: (1) Usual diabetes care with physician (control), (2) diabetes care with physician and community pharmacist (intervention). The community pharmacist will adopt the core elements of the medication therapy management model in reviewing the medications of participants as well as provide relevant lifestyle counselling and health education via a face-to-face consultation at the clinic and subsequently through telephonic correspondences. The primary outcome will be change in HbA1c over 6 months. Secondary outcomes include blood pressure, lipid markers, distress level, self-care capabilities, quality of life, productivity, and direct medical costs.

Significance: The outcomes of the community pharmacist-involved collaborative care model will support future implementation and integration of this care model into the standard of care in Singapore so as to optimize the management of type 2 diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 265
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 99 Years

Eligibility

Inclusion Criteria:

• All individuals aged 21 years and above, diagnosed with type 2 diabetes mellitus with a baseline HbA1c of more than 7.0% and taking 5 or more chronic medications

Exclusion Criteria:

• Individuals with type 1 diabetes mellitus

• Mentally incapacitated individuals

• Individuals who are illiterate and unable to communicate in English, Malay, or Chinese (Mandarin)

• Individuals who are not able to complete the questionnaires

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Other:
• Community pharmacist-involved collaborative care
Community pharmacist-involved collaborative care in the management of individuals with type 2 diabetes mellitus
• Usual care
Usual care with physician and as needed visit to the nurse

Locations

Country	Name	City	State
Singapore	Keat Hong Family Medicine Clinic	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c level	Change in HbA1c level over 6 months	Baseline and 6 months
Secondary	Change in blood pressure	Change in systolic blood pressure and diastolic blood pressure	Baseline and 6 months
Secondary	Change in lipid markers	Change in total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglyceride levels	Baseline and 6 months
Secondary	Change in diabetes-related distress	Measured by 20-item Problem Areas in Diabetes (PAID), with each item scoring from 0 to 4. The total score is computed by the sum of score of each item, ranging from 0 to 100 (highest distress level).	Baseline and 6 months
Secondary	Change in general health status	Measured by EuroQoL 5-Dimension 5-Level (EQ-5D-5L), each item scored individually on a scale of 1 to 5 (1 being least problem and 5 being most problem). EQ-5D-5L comes with a visual analogue scale assessing general health-related quality of life on that day, ranging from 0 (worst health imaginable) to 100 (best health imaginable).	Baseline and 6 months
Secondary	Change in diabetes-specific quality of life	Measured by the 21-item Audit of Diabetes-Dependent Quality of Life (ADDQoL), with 2 global general quality of life questions and 19 domains with weighted score between impact and importance. The average weighted impact is the average of the impact of all domains (ranging from -9, being worst quality of life to +3, being best quality of life).	Baseline and 6 months
Secondary	Change in general work productivity	Measured by 6-item Work Productivity Activity Impairment-Global Health (WPAI-GH), four primary outcomes based on the questions including: Per cent of work time missed due to health conditions (absenteeism): Q2/(Q2+Q4).; Per cent impairment while working due to health conditions (presenteeism): Q5/10.; Per cent overall work impairment due to health: Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))×(Q5/10)].; Per cent impairment in activities due to health: Q6/10.	Baseline and 6 months
Secondary	Change in self efficacy and self-care capabilities	Measured by Summary of Diabetes Self-Care Activities scale (SDSCA),comprised of items assessing five domains of diabetes self-management which are "general diet (2 items), specific diet (2 items), exercise (2 items), blood glucose testing (2 items) and foot care (2 items) and the medication self-management component and smoking self-management component. Each item will be reported as a mean across the sample and analysed individually.	Baseline and 6 months
Secondary	Incidence of hypoglycemia	Incidence of hypoglycemia over 6 months	Baseline and 6 months
Secondary	Cost effectiveness analysis	Cost effectiveness of the community pharmacist-involved collaborative care model	6 months