Text Size

Pharmaceutical Care of Ambulatory Elderly Diabetes Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jyun-Hong Chen, Nantou Hospital
ClinicalTrials.gov Identifier:
NCT01455727
First received: October 14, 2011
Last updated: September 13, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention
Diabetes Mellitus
 Other: Pharmaceutical care
Other: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Depression Diabetes
U.S. FDA Resources

Further study details as provided by Nantou Hospital:

Primary Outcome Measures:
  • Hgb A1c change [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    baseline, second measurement during 3 to 6 month after baseline, and the last measurement during 9 to 12 month after baseline


Secondary Outcome Measures:
  • Mini-Mental State Examination(MMSE) Score change [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    baseline and the second test was performed after 3 month.

  • Taiwan Geriatric Depression Scale(GDS) Score change [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    baseline and the second test was performed after 3 month.


Enrollment: 100
Study Start Date: August 2011
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 Other: 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.
Active Comparator: Usual care
Patients received usual care directed by their physician.
 Other: Usual care
Control patients received usual care directed by their physician.

  Eligibility

Ages Eligible for Study:   65 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01455727

Locations
Taiwan
Nantou Hospital
Nantou, Taiwan, 540
Sponsors and Collaborators
Nantou Hospital
  More Information

No publications provided

Responsible Party: Jyun-Hong Chen, Clinical Pharmacist, Pharmacy Department, Nantou Hospital, Nantou Hospital
ClinicalTrials.gov Identifier: NCT01455727     History of Changes
Other Study ID Numbers: 100B4022-100MID-08
Study First Received: October 14, 2011
Last Updated: September 13, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by Nantou Hospital:
Pharmaceutical care
Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013