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

NCT03531944 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 265

Last updated 2021-03-02

No results posted yet for this study

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

Interventions

OTHER

Community pharmacist-involved collaborative care

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

OTHER

Usual care

Usual care with physician and as needed visit to the nurse

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-06
Primary Completion
2020-03-31
Completion
2020-03-31

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03531944 on ClinicalTrials.gov