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Pharmaceutical Care Service in Diabetes (IMPACT4-DM)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pharmaceutical care
Sponsored by
Pusan National University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes Mellitus, Type 2, Pharmaceutical Services

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Pharmaceutical care

    Usual care

    Arm Description

    Participants 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.

    Participants received the usual care, which includes traditional consultation with pharmacists as well as traditional medical services provided by physicians, nurses, and dietitian.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    HbA1c level at 9 months
    Random blood glucose level at 9 months
    Blood pressure at 9 months
    Cholesterol level at 9 months
    Proportion of participants taking statins 9 months
    Proportion of participants managing diabetes complications at 9 months
    Morisky Medication Adherence Scale at 9 months
    5-level version of the EQ-5D at 9 months
    EQ Visual Analogue Scale at 9 months
    Problem Areas In Diabetes-Korean questionnaire at 9 months
    Patient Satisfaction Questionnaire-Korean at 9 months
    Cost-effectiveness of pharmaceutical care at 9 months

    Full Information

    First Posted
    October 26, 2016
    Last Updated
    November 2, 2016
    Sponsor
    Pusan National University
    Collaborators
    Pusan National University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02955875
    Brief Title
    Pharmaceutical Care Service in Diabetes
    Acronym
    IMPACT4-DM
    Official Title
    Impact of Pharmaceutical Care Service for Type 2 Diabetes Mellitus Patients in Korea
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    May 2016 (Actual)
    Study Completion Date
    June 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Pusan National University
    Collaborators
    Pusan National University Hospital

    4. Oversight

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Type 2
    Keywords
    Diabetes Mellitus, Type 2, Pharmaceutical Services

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    257 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Pharmaceutical care
    Arm Type
    Experimental
    Arm Description
    Participants 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.
    Arm Title
    Usual care
    Arm Type
    No Intervention
    Arm Description
    Participants received the usual care, which includes traditional consultation with pharmacists as well as traditional medical services provided by physicians, nurses, and dietitian.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Pharmaceutical care
    Other Intervention Name(s)
    Pharmaceutical service
    Intervention Description
    Outpatient drug history management, drug regimen review, patient counseling and education before and/or after physician evaluation on the day of facility visit
    Primary Outcome Measure Information:
    Title
    Medications knowledge at 9 months
    Description
    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.
    Time Frame
    9 months
    Secondary Outcome Measure Information:
    Title
    HbA1c level at 9 months
    Time Frame
    9 months
    Title
    Random blood glucose level at 9 months
    Time Frame
    9 months
    Title
    Blood pressure at 9 months
    Time Frame
    9 months
    Title
    Cholesterol level at 9 months
    Time Frame
    9 months
    Title
    Proportion of participants taking statins 9 months
    Time Frame
    9 months
    Title
    Proportion of participants managing diabetes complications at 9 months
    Time Frame
    9 months
    Title
    Morisky Medication Adherence Scale at 9 months
    Time Frame
    9 months
    Title
    5-level version of the EQ-5D at 9 months
    Time Frame
    9 months
    Title
    EQ Visual Analogue Scale at 9 months
    Time Frame
    9 months
    Title
    Problem Areas In Diabetes-Korean questionnaire at 9 months
    Time Frame
    9 months
    Title
    Patient Satisfaction Questionnaire-Korean at 9 months
    Time Frame
    9 months
    Title
    Cost-effectiveness of pharmaceutical care at 9 months
    Time Frame
    9 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

    Pharmaceutical Care Service in Diabetes

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