- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01455727
Pharmaceutical Care of Ambulatory Elderly Diabetes Patients
September 13, 2012 updated by: Jyun-Hong Chen, Nantou Hospital
This trial will try to perform pharmaceutical care on ambulatory elderly diabetes patients.
To provide appropriate diabetes education administration, identify and resolve drug-related problems, assess the appropriateness of their medications, establish the mechanism of medication consultations.
Each patient will be assessed by the MMSE(Mini-Mental State Examination) and GDS(Geriatric Depression Scale).
The effectiveness of pharmacist's intervention will be assessed by lab data and some questionnaires.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Nantou, Taiwan, 540
- Nantou Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 90 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 65 years or older
- A1c greater than or equal to 9.0
Exclusion Criteria:
- Not expected to live for the duration of the study
- Unwillingness to participate and attend pharmacist visits
- Unwillingness to participate the questionnaires(MMSE, GDS)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pharmaceutical care
The Pharmacist provided Pharmaceutical care on the ambulatory elderly Diabetes patients, provided recommendation to the physician and reffered the patients to other diabetes-care-team members, including the CDEs and dietitians.
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The Pharmacist provided Pharmaceutical care on the ambulatory elderly Diabetes patients, provided recommendation to the physician and reffered the patients to other diabetes-care-team members, including the CDEs and dietitians.
|
Active Comparator: Usual care
Patients received usual care directed by their physician.
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Control patients received usual care directed by their physician.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hgb A1c change
Time Frame: 12 month
|
baseline, second measurement during 3 to 6 month after baseline, and the last measurement during 9 to 12 month after baseline
|
12 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mini-Mental State Examination(MMSE) Score change
Time Frame: 1 year
|
baseline and the second test was performed after 3 month.
|
1 year
|
Taiwan Geriatric Depression Scale(GDS) Score change
Time Frame: 1 year
|
baseline and the second test was performed after 3 month.
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1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2011
Primary Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
October 14, 2011
First Submitted That Met QC Criteria
October 18, 2011
First Posted (Estimate)
October 20, 2011
Study Record Updates
Last Update Posted (Estimate)
September 17, 2012
Last Update Submitted That Met QC Criteria
September 13, 2012
Last Verified
September 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 100B4022-100MID-08
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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