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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014