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

Universitas Padjadjaran

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Behavioral: Pharmacist Counseling Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04313829

DM-202003.01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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220 participants in 2 patient groups

Intervention group

Active Comparator group

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.

Treatment:

Behavioral: Pharmacist Counseling Intervention

Control group

No Intervention group

Description:

The control group received standard medicine information services by Pharmacists.