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

NCT03531944 | Completed

• 1 other identifier: H-18-019
• Study Type: interventional
• Target: 265
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c level

  Change in HbA1c level over 6 months

  Baseline and 6 months

Secondary Outcomes (9)

• Change in blood pressure

  Baseline and 6 months

• Change in lipid markers

  Baseline and 6 months

• Change in diabetes-related distress

  Baseline and 6 months

• Change in general health status

  Baseline and 6 months

• Change in diabetes-specific quality of life

  Baseline and 6 months

Study Arms (2)

Community pharmacist-involved care

EXPERIMENTAL

Community pharmacist-involved collaborative care in the management of type 2 diabetes mellitus

Other: Community pharmacist-involved collaborative care

Usual care

PLACEBO COMPARATOR

Usual care with physician and as needed referral to nurses

Other: Usual care

Interventions

Community pharmacist-involved collaborative care OTHER

Community pharmacist-involved collaborative care in the management of individuals with type 2 diabetes mellitus

Community pharmacist-involved care

Usual care OTHER

Usual care with physician and as needed visit to the nurse

Usual care

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Singapore: lead

Study Sites (1)

Keat Hong Family Medicine Clinic

Singapore, 689687, Singapore

Location

Related Publications (1)

• Lum ZK, Tan JY, Wong CSM, Kok ZY, Kwek SC, Tsou KYK, Gallagher PJ, Lee JY. Reducing economic burden through split-shared care model for people living with uncontrolled type 2 diabetes and polypharmacy: a multi-center randomized controlled trial. BMC Health Serv Res. 2024 Jun 22;24(1):760. doi: 10.1186/s12913-024-11199-2.

  PMID: 38907254 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 9, 2018
• First Posted: May 22, 2018
• Study Start: June 6, 2018
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: March 2, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)