Pharmacist Counseling on the Health-related Quality of Life of Patients With Type 2 Diabetes Mellitus

March 19, 2020 updated by: Universitas Padjadjaran

Impact of Pharmacist Counseling on the Health-related Quality of Life of Patients With Type 2 Diabetes Mellitus: a Cluster Randomized Controlled Study

The quality of life (QoL) of patients with type 2 diabetes mellitus (T2DM) is a measure of the successful outcomes of therapy. The program of management of chronic diseases "Program Pengelolaan Penyakit Kronis" (Prolanis) among patients with hypertension and T2DM is a new strategy of the Badan Penyelenggara Jaminan Sosial (BPJS), which is the Indonesian national health insurance system. The impact of pharmacist counseling interventions on health-related QoL (HRQoL) was analyzed in Prolanis T2DM patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A cluster randomized controlled trial that was designed to include two groups (control (n = 111) and intervention (n = 109) groups), and pre- and post-test procedures were conducted. The participants were Prolanis T2DM patients who attended four primary health-care centers (Puskesmas) in Makassar City, South Sulawesi, Indonesia from August 2017 to August 2018. The intervention group received systematic counseling for 6 months. The data were collected using the Bahasa Indonesia version of the European Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L) questionnaire and were analyzed using EQ-5D preference weight for each health state with the Indonesian EQ-5D-5L value Set. Furthermore, the EQ-5D index and the EQ-5D VAS score were calculated and HbA1c levels were assessed.

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • South Sulawesi
      • Makassar, South Sulawesi, Indonesia
        • Puskesmas Antang
      • Makassar, South Sulawesi, Indonesia
        • Puskesmas Batua
      • Makassar, South Sulawesi, Indonesia
        • Puskesmas Jongaya
      • Makassar, South Sulawesi, Indonesia
        • Puskesmas Tamalanrea

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Registration in the Prolanis at BPJS Makassar City,
  • Age between 20 and 65 years,
  • HbA1c level ≥6.5%, and
  • Willingness to participate in research by signing an informed consent (for all T2DM patients with or without comorbidities)

Exclusion Criteria:

  • Irregular control schedules,
  • Incomplete medical record data,
  • Circumstances that did not allow filling out the questionnaires (e.g., inability to speak, see, or hear)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Intervention group
The intervention group received Pharmacist counseling for 15 minutes include giving standard medicine information service and explaining the validated pharmacist counseling module which contained the T2DM causes and symptoms, the reasons for the importance of therapy, the non-pharmacological and pharmacological therapies available (drug names, strengths, indications, rules of use, side effects, interactions, and storage), the purpose of controlling blood sugar levels, medications that need to be avoided, and guidelines for missed dose.
Behavioral: Pharmacist Counseling Intervention
We used the counseling module (in the form of a guide book) for pharmacist-based counseling that had been validated regarding constructive content by an endocrinologist and a pharmacist expert in diabetes drug counseling. The module explained the T2DM causes and symptoms, the reasons for the importance of therapy, the non-pharmacological and pharmacological therapies available (drug names, strengths, indications, rules of use, side effects, interactions, and storage), the purpose of controlling blood sugar levels, medications that need to be avoided, and guidelines for missed doses. The pharmacists should explain all the content within the module in 15 minutes to each patient of the intervention group each month for 6 months. As an ethical consideration, the control group patients were given the same explanation module through pharmacist counseling after the study finished.
NO_INTERVENTION: Control group
The control group received standard medicine information services by Pharmacists.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of Quality of Life (QoL) using the Euro Quality of Life 5 Dimension 5 Level (EQ-5D-5L) questionnaire
Time Frame: 6 months

The QoL of Prolanis T2DM patients was measured using the Euro Quality of Life 5 Dimension 5 Level (EQ-5D-5L) questionnaire.

The EQ-5D-5L questionnaire consists of two parts: a descriptive system and a Visual Analogue Scale (VAS).

The descriptive system describes the health state and consists of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Patients who reported problems were then categorized into two categories, a "has no problem" category (health state code of 1) and "has problem" category (health state code of 2-5) for each level of each dimension.

The second part of the EQ-5D-5L questionnaire is the EQ-VAS, which is a thermometer-like scale (ranging from 0 to 100) that reflects the patient's health in general. EQ-VAS represents the patient perspective, where zero indicates the worst imaginable health state and 100 reflects the best imaginable health state.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of HbA1c
Time Frame: 6 months
Measurement of HbA1c was done over a period of 2-4 months. In addition, HbA1c was also be considered compatible with therapy.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitas Padjadjaran

Collaborators

Ministry of Research, Technology and Higher Education of the Republic of Indonesia

Investigators

  • Principal Investigator: Fajriansyah Fajriansyah, Master, Faculty of Pharmacy Universitas Padjadjaran Bandung

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2017

Primary Completion (ACTUAL)

February 1, 2018

Study Completion (ACTUAL)

August 31, 2018

Study Registration Dates

First Submitted

March 16, 2020

First Submitted That Met QC Criteria

March 16, 2020

First Posted (ACTUAL)

March 18, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 23, 2020

Last Update Submitted That Met QC Criteria

March 19, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DM-202003.01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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