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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04313829
• Other study ID #: DM-202003.01
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: August 31, 2018

Study information

• Verified date: March 2020
• Source: Universitas Padjadjaran
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: August 31, 2018
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
Indonesia	Puskesmas Antang	Makassar	South Sulawesi
Indonesia	Puskesmas Batua	Makassar	South Sulawesi
Indonesia	Puskesmas Jongaya	Makassar	South Sulawesi
Indonesia	Puskesmas Tamalanrea	Makassar	South Sulawesi

Sponsors (2)

Lead Sponsor	Collaborator
Universitas Padjadjaran	Ministry of Research, Technology and Higher Education of the Republic of Indonesia

Country where clinical trial is conducted

Indonesia, 

References & Publications (9)

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. — View 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. Review. Portuguese. — View 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. — View Citation

Kjeldsen LJ, Bjerrum L, Dam P, Larsen BO, Rossing C, Søndergaard 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. — View 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. Review. — View 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: — View Citation

Purba FD, Hunfeld JAM, Iskandarsyah A, Fitriana TS, Sadarjoen SS, Ramos-Goñi 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. — View Citation

Steinsbekk A, Rygg LØ, 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. d — View 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 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	6 months