Clinical trial NCT04313829: 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
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Universitas Padjadjaran
Sponsor class: OTHER
Collaborators: name: Ministry of Research, Technology and Higher Education of the Republic of Indonesia
First posted: 2020-03-18
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Measurement of Quality of Life (QoL) using the Euro Quality of Life 5 Dimension 5 Level (EQ-5D-5L) questionnaire
timeFrame: 6 months
Secondary outcomes:
measure: Measurement of HbA1c
timeFrame: 6 months
Other outcomes:
Locations:
city: Makassar
country: Indonesia
facility: Puskesmas Antang
state: South Sulawesi
city: Makassar
country: Indonesia
facility: Puskesmas Batua
state: South Sulawesi
city: Makassar
country: Indonesia
facility: Puskesmas Jongaya
state: South Sulawesi
city: Makassar
country: Indonesia
facility: Puskesmas Tamalanrea
state: South Sulawesi
Study officials:
affiliation: Faculty of Pharmacy Universitas Padjadjaran Bandung
name: Fajriansyah Fajriansyah, Master
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
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