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Completed

NCT Number: NCT02955875

Pharmaceutical Care Service in Diabetes

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

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pharmaceutical Care

Behavioral

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

Other names: Pharmaceutical service

Primary outcomes

  1. Medications knowledge at 9 months

    Time frame: 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.

Secondary outcomes

  1. HbA1c level at 9 months

    Time frame: 9 months

  2. Random blood glucose level at 9 months

    Time frame: 9 months

  3. Blood pressure at 9 months

    Time frame: 9 months

  4. Cholesterol level at 9 months

    Time frame: 9 months

  5. Proportion of participants taking statins 9 months

    Time frame: 9 months

  6. Proportion of participants managing diabetes complications at 9 months

    Time frame: 9 months

  7. Morisky Medication Adherence Scale at 9 months

    Time frame: 9 months

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

    Time frame: 9 months

  9. EQ Visual Analogue Scale at 9 months

    Time frame: 9 months

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

    Time frame: 9 months

  11. Patient Satisfaction Questionnaire-Korean at 9 months

    Time frame: 9 months

  12. Cost-effectiveness of pharmaceutical care at 9 months

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

Pusan National University

Other

Collaborators

  • Pusan National University Hospital

Registry information

Official study title

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

Acronym: IMPACT4-DM

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 4, 2016
Registry last updated
Nov 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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