NCT04313829

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 16, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 18, 2020

Completed
Last Updated

March 23, 2020

Status Verified

March 1, 2020

Enrollment Period

6 months

First QC Date

March 16, 2020

Last Update Submit

March 19, 2020

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Secondary Outcomes (1)

  • Measurement of HbA1c

    6 months

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

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

Control group

NO INTERVENTION

The control group received standard medicine information services by Pharmacists.

Interventions

Pharmacist Counseling InterventionBEHAVIORAL

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.

Intervention group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Puskesmas Antang

Makassar, South Sulawesi, Indonesia

Location

Puskesmas Batua

Makassar, South Sulawesi, Indonesia

Location

Puskesmas Jongaya

Makassar, South Sulawesi, Indonesia

Location

Puskesmas Tamalanrea

Makassar, South Sulawesi, Indonesia

Location

Related Publications (9)

  • 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.

    PMID: 28695543BACKGROUND

  • 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.

    PMID: 22684529BACKGROUND

  • 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.

    PMID: 21479777BACKGROUND

  • 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.

    PMID: 22824531RESULT

  • 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.

    PMID: 26973912RESULT

  • 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.

    PMID: 24798710RESULT

  • 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.

    PMID: 27579326RESULT

  • 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.

    PMID: 29311916RESULT

  • 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.

    PMID: 26516756RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Fajriansyah Fajriansyah, Master

    Faculty of Pharmacy Universitas Padjadjaran Bandung

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2020

First Posted

March 18, 2020

Study Start

August 1, 2017

Primary Completion

February 1, 2018

Study Completion

August 31, 2018

Last Updated

March 23, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

ID(4)