Pharmaceutical Care of Ambulatory Elderly Diabetes Patients

• Sponsor: Nantou Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01455727
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Diabetes Mellitus	Other: Pharmaceutical care; Other: Usual care	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Study Start Date: Aug 1, 2011
• Actual Primary Completion Date: Aug 1, 2012

Arms and Interventions

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.	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.

Outcome Measures

Primary Outcome Measures

1. Hgb A1c change [12 month]

   baseline, second measurement during 3 to 6 month after baseline, and the last measurement during 9 to 12 month after baseline

Secondary Outcome Measures

1. Mini-Mental State Examination(MMSE) Score change [1 year]

   baseline and the second test was performed after 3 month.

2. Taiwan Geriatric Depression Scale(GDS) Score change [1 year]

   baseline and the second test was performed after 3 month.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Nantou Hospital	Nantou		Taiwan	540

Sponsors and Collaborators

• Nantou Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jyun-Hong Chen, Clinical Pharmacist, Pharmacy Department, Nantou Hospital, Nantou Hospital
• ClinicalTrials.gov Identifier: NCT01455727
• Other Study ID Numbers: 100B4022-100MID-08
• First Posted: Oct 20, 2011
• Last Update Posted: Sep 17, 2012
• Last Verified: Sep 1, 2012

• Keywords provided by Jyun-Hong Chen, Clinical Pharmacist, Pharmacy Department, Nantou Hospital, Nantou Hospital: Pharmaceutical care; Diabetes Mellitus
• Additional relevant MeSH terms: Diabetes Mellitus

Study Results

No Results Posted as of Sep 17, 2012