Pharmaceutical Care Service in Diabetes
IMPACT4-DM
Impact of Pharmaceutical Care Service for Type 2 Diabetes Mellitus Patients in Korea
1 other identifier
interventional
257
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus-type-2
Started Jan 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 26, 2016
CompletedFirst Posted
Study publicly available on registry
November 4, 2016
CompletedNovember 4, 2016
November 1, 2016
1.3 years
October 26, 2016
November 2, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
9 months
Secondary Outcomes (12)
HbA1c level at 9 months
9 months
Random blood glucose level at 9 months
9 months
Blood pressure at 9 months
9 months
Cholesterol level at 9 months
9 months
Proportion of participants taking statins 9 months
9 months
- +7 more secondary outcomes
Study Arms (2)
Pharmaceutical care
EXPERIMENTALParticipants 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.
Usual care
NO INTERVENTIONParticipants received the usual care, which includes traditional consultation with pharmacists as well as traditional medical services provided by physicians, nurses, and dietitian.
Interventions
Outpatient drug history management, drug regimen review, patient counseling and education before and/or after physician evaluation on the day of facility visit
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pusan National Universitylead
- Pusan National University Hospitalcollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
October 26, 2016
First Posted
November 4, 2016
Study Start
January 1, 2015
Primary Completion
May 1, 2016
Study Completion
June 1, 2016
Last Updated
November 4, 2016
Record last verified: 2016-11