Pharmacist Counseling on the Health-related Quality of Life of Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

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.
    

Intervention name(s): Pharmacist Counseling Intervention
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Single (Care Provider)
Primary purpose: Supportive Care