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

Primary Purpose

Type 2 Diabetes Mellitus

Status

Completed

Phase

Not Applicable

Locations

Indonesia

Study Type

Interventional

Intervention

Pharmacist Counseling Intervention

About this trial

This is an interventional supportive care trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Puskesmas Antang
Puskesmas Batua
Puskesmas Jongaya
Puskesmas Tamalanrea

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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.

The control group received standard medicine information services by Pharmacists.

Outcomes

Primary Outcome Measures

Measurement of Quality of Life (QoL) using the Euro Quality of Life 5 Dimension 5 Level (EQ-5D-5L) questionnaire

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.

Secondary Outcome Measures

Measurement of HbA1c

Measurement of HbA1c was done over a period of 2-4 months. In addition, HbA1c was also be considered compatible with therapy.

Full Information

NCT ID

NCT04313829

First Posted

March 16, 2020

Last Updated

March 19, 2020

Sponsor

Universitas Padjadjaran

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04313829

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

August 1, 2017 (Actual)

Primary Completion Date

February 1, 2018 (Actual)

Study Completion Date

August 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Universitas Padjadjaran

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

All patients provided written informed consent before participating in the study. The participants were administered the EQ-5D-5L questionnaire in the first month of the study, as a pre-test procedure. The patients in the control group participated in the standard Prolanis T2DM program for 6 months and were asked to fill out the questionnaire again at the 6-month time point, as a post-test procedure. The patients in the intervention group participated in the standard Prolanis T2DM program and received a 15 min face-to-face counseling session from a pharmacist once a month for 6 months. At the 6-month time point, subjects in the intervention group were asked to fill out the EQ-5D-5L questionnaire again, as a post-test procedure. Patients in the control group also received a 15 min face-to-face counseling session from a pharmacist once a month for 6 months after the intervention study was completed.

Masking

Care Provider

Masking Description

Cluster randomization by institution was used in this study. The four Puskesmas were randomized by asking the person in charge of the Prolanis at these centers to choose a closed envelope containing an identifier indicating the control group or the intervention group. Two Puskesmas were used as the control group and the remaining two were used as the intervention group.

Allocation

Randomized

Enrollment

220 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention group

Arm Type

Active Comparator

Arm Description

Arm Title

Control group

Arm Type

No Intervention

Arm Description

The control group received standard medicine information services by Pharmacists.

Intervention Type

Behavioral

Intervention Name(s)

Pharmacist Counseling Intervention

Intervention Description

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.

Primary Outcome Measure Information:

Title

Measurement of Quality of Life (QoL) using the Euro Quality of Life 5 Dimension 5 Level (EQ-5D-5L) questionnaire

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Measurement of HbA1c

Description

Measurement of HbA1c was done over a period of 2-4 months. In addition, HbA1c was also be considered compatible with therapy.

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fajriansyah Fajriansyah, Master

Organizational Affiliation

Faculty of Pharmacy Universitas Padjadjaran Bandung

Official's Role

Principal Investigator

Facility Information:

Facility Name

Puskesmas Antang

City

Makassar

State/Province

South Sulawesi

Country

Indonesia

Facility Name

Puskesmas Batua

City

Makassar

State/Province

South Sulawesi

Country

Indonesia

Facility Name

Puskesmas Jongaya

City

Makassar

State/Province

South Sulawesi

Country

Indonesia

Facility Name

Puskesmas Tamalanrea

City

Makassar

State/Province

South Sulawesi

Country

Indonesia

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28695543

Citation

Purba FD, Hunfeld JAM, Iskandarsyah A, Fitriana TS, Sadarjoen SS, Ramos-Goni JM, Passchier J, Busschbach JJV. The Indonesian EQ-5D-5L Value Set. Pharmacoeconomics. 2017 Nov;35(11):1153-1165. doi: 10.1007/s40273-017-0538-9.

Results Reference

background

PubMed Identifier

22684529

Citation

Agborsangaya CB, Lau D, Lahtinen M, Cooke T, Johnson JA. Health-related quality of life and healthcare utilization in multimorbidity: results of a cross-sectional survey. Qual Life Res. 2013 May;22(4):791-9. doi: 10.1007/s11136-012-0214-7. Epub 2012 Jun 9.

Results Reference

background

PubMed Identifier

21479777

Citation

Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.

Results Reference

background

PubMed Identifier

22824531

Citation

Steinsbekk A, Rygg LO, Lisulo M, Rise MB, Fretheim A. Group based diabetes self-management education compared to routine treatment for people with type 2 diabetes mellitus. A systematic review with meta-analysis. BMC Health Serv Res. 2012 Jul 23;12:213. doi: 10.1186/1472-6963-12-213.

Results Reference

result

PubMed Identifier

26973912

Citation

Megari K. Quality of Life in Chronic Disease Patients. Health Psychol Res. 2013 Sep 23;1(3):e27. doi: 10.4081/hpr.2013.e27. eCollection 2013 Sep 24.

Results Reference

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PubMed Identifier

24798710

Citation

Kjeldsen LJ, Bjerrum L, Dam P, Larsen BO, Rossing C, Sondergaard B, Herborg H. Safe and effective use of medicines for patients with type 2 diabetes - A randomized controlled trial of two interventions delivered by local pharmacies. Res Social Adm Pharm. 2015 Jan-Feb;11(1):47-62. doi: 10.1016/j.sapharm.2014.03.003. Epub 2014 Apr 12.

Results Reference

result

PubMed Identifier

27579326

Citation

Nichols GA, Rosales AG, Kimes TM, Tunceli K, Kurtyka K, Mavros P. The Change in HbA1c Associated with Initial Adherence and Subsequent Change in Adherence among Diabetes Patients Newly Initiating Metformin Therapy. J Diabetes Res. 2016;2016:9687815. doi: 10.1155/2016/9687815. Epub 2016 Aug 7.

Results Reference

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PubMed Identifier

29311916

Citation

van Eikenhorst L, Taxis K, van Dijk L, de Gier H. Pharmacist-Led Self-management Interventions to Improve Diabetes Outcomes. A Systematic Literature Review and Meta-Analysis. Front Pharmacol. 2017 Dec 14;8:891. doi: 10.3389/fphar.2017.00891. eCollection 2017.

Results Reference

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PubMed Identifier

26516756

Citation

Gusmai Lde F, Novato Tde S, Nogueira Lde S. [The influence of quality of life in treatment adherence of diabetic patients: a systematic review]. Rev Esc Enferm USP. 2015 Oct;49(5):839-46. doi: 10.1590/S0080-623420150000500019. Portuguese.

Results Reference

result

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

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