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Type 2 Diabetes MellitusNCT04313829

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

A study testing Pharmacist Counseling Intervention in people with Type 2 Diabetes Mellitus, run by Universitas Padjadjaran at 4 sites in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Pharmacist Counseling Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
4 sitesIndonesia
Study dates
1 Aug 2017to 31 Aug 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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 locations and contacts

4 sites in 1 country.

Indonesia4 sites

  • Puskesmas Antang

    Makassar, South Sulawesi

  • Puskesmas Batua

    Makassar, South Sulawesi

  • Puskesmas Jongaya

    Makassar, South Sulawesi

  • Puskesmas Tamalanrea

    Makassar, South Sulawesi

Other trials in Indonesia

About this study

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

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.

Read the 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.

Being tested
Pharmacist Counseling Intervention
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pharmacist Counseling InterventionBehavioural

    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.

Study groups in NCT04313829
Study groupRoleWhat they receive
Intervention groupActive comparatorThe 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.
Receives: Behavioral: Pharmacist Counseling Intervention
Control groupNo interventionThe control group received standard medicine information services by Pharmacists.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months

Secondary outcomes (1)

  1. 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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2020
  2. Study start1 Aug 2017
  3. Primary completion1 Feb 2018
  4. Study completion31 Aug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Care provider
Enrolment
220 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04313829
Sponsor's protocol ID
DM-202003.01
Status last verified
Mar 2020
First submitted
16 Mar 2020
Last updated
23 Mar 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28695543

  • 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.

    PubMed 22684529

  • 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.

    PubMed 21479777

  • 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.

    PubMed 22824531

  • 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.

    PubMed 26973912

  • 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.

    PubMed 24798710

  • 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.

    PubMed 27579326

  • 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.

    PubMed 29311916

  • 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.

    PubMed 26516756

Questions about this trial

What is this clinical trial studying?

A study testing Pharmacist Counseling Intervention in people with Type 2 Diabetes Mellitus, run by Universitas Padjadjaran at 4 sites in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measurement of Quality of Life (QoL) using the Euro Quality of Life 5 Dimension 5 Level (EQ-5D-5L) questionnaire (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04313829, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2020.

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