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Diabetes Mellitus, Type 2IMPACT4-DMNCT02955875

Pharmaceutical Care Service in Diabetes

A study testing Pharmaceutical care in people with Diabetes Mellitus, Type 2, run by Pusan National University.

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 purpose of this study is to examine the effectiveness of pharmaceutical care service in the management of poorly controlled type 2 diabetes mellitus. Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Pharmaceutical care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
257 participants
Where
No sites listed yet
Study dates
Jan 2015to Jun 2016
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 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Inclusion Criteria: Patients who visit Endocrinology and Metabolism department of Pusan National University Hospital, are with type 2 diabetes mellitus, and meet one of the following criteria

  • Who are diagnosed with type 2 diabetes mellitus for the first time
  • Who need the education for medication or disease
  • Who are with poorly controlled blood glucose
  • Who have poor medication adherence
  • Who have been hospitalized with diabetes complication or poorly controlled blood glucose
  • Whose physician recommend the pharmaceutical care to them

Exclusion Criteria: Patients who meet one of the following criteria

  • Who are with gestational diabetes
  • Who are not able to respond to questionnaires
  • Who are with severe condition such as cerebrovascular disease, mental disorder, and acquired immune deficiency syndrome
  • Who are not able to be followed-up during 9 months in Pusan National University Hospital

About this study

Official title: Impact of Pharmaceutical Care Service for Type 2 Diabetes Mellitus Patients in Korea

The purpose of this study is to examine the effectiveness of pharmaceutical care service in the management of poorly controlled type 2 diabetes mellitus.

Being tested
Pharmaceutical care
Keywords
Diabetes Mellitus, Type 2, Pharmaceutical Services
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.

  • Pharmaceutical careBehavioural

    Also called Pharmaceutical service

    Outpatient drug history management, drug regimen review, patient counseling and education before and/or after physician evaluation on the day of facility visit

Study groups in NCT02955875
Study groupRoleWhat they receive
Pharmaceutical careExperimentalParticipants received systematically organized pharmaceutical care services, which were provided by pharmacists, in addition to the usual care. The usual care includes traditional consultation with pharmacists as well as traditional medical services provided by physicians, nurses, and dietitian.
Receives: Behavioral: Pharmaceutical care
Usual careNo interventionParticipants received the usual care, which includes traditional consultation with pharmacists as well as traditional medical services provided by physicians, nurses, and dietitian.

What is being measured

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

  1. Medications knowledge at 9 months

    Patients' knowledge about diabetes medications was measured by an instrument. The instrument includes items such as the name of medication, mechanism of action, dosage, and side effects.

    Measured: 9 months

Secondary outcomes (12)

  1. HbA1c level at 9 months

    Measured: 9 months

  2. Random blood glucose level at 9 months

    Measured: 9 months

  3. Blood pressure at 9 months

    Measured: 9 months

  4. Cholesterol level at 9 months

    Measured: 9 months

  5. Proportion of participants taking statins 9 months

    Measured: 9 months

  6. Proportion of participants managing diabetes complications at 9 months

    Measured: 9 months

  7. Morisky Medication Adherence Scale at 9 months

    Measured: 9 months

  8. 5-level version of the EQ-5D at 9 months

    Measured: 9 months

  9. EQ Visual Analogue Scale at 9 months

    Measured: 9 months

  10. Problem Areas In Diabetes-Korean questionnaire at 9 months

    Measured: 9 months

  11. Patient Satisfaction Questionnaire-Korean at 9 months

    Measured: 9 months

  12. Cost-effectiveness of pharmaceutical care at 9 months

    Measured: 9 months

Timeline

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

  1. First posted4 Nov 2016 (estimated)
  2. Study startJan 2015
  3. Primary completionMay 2016
  4. Study completionJun 2016

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
257 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02955875
Sponsor's protocol ID
PNU-2014-001
Acronym
IMPACT4-DM
Status last verified
Nov 2016
First submitted
26 Oct 2016
Last updated
4 Nov 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing Pharmaceutical care in people with Diabetes Mellitus, Type 2, run by Pusan National University.

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

Who may be eligible to take part?

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 4 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

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?

Medications knowledge at 9 months (time frame: 9 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 NCT02955875.

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 4 Nov 2016.

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