NCT01455727

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 20, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Last Updated

September 17, 2012

Status Verified

September 1, 2012

Enrollment Period

1 year

First QC Date

October 14, 2011

Last Update Submit

September 13, 2012

Conditions

Keywords

Pharmaceutical careDiabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Hgb A1c change

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

    12 month

Secondary Outcomes (2)

  • Mini-Mental State Examination(MMSE) Score change

    1 year

  • Taiwan Geriatric Depression Scale(GDS) Score change

    1 year

Study Arms (2)

Pharmaceutical care

EXPERIMENTAL

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

Usual care

ACTIVE COMPARATOR

Patients received usual care directed by their physician.

Other: Usual care

Interventions

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.

Pharmaceutical care

Control patients received usual care directed by their physician.

Usual care

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age 65 years or older
  • A1c greater than or equal to 9.0

You may not qualify if:

  • Not expected to live for the duration of the study
  • Unwillingness to participate and attend pharmacist visits
  • Unwillingness to participate the questionnaires(MMSE, GDS)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nantou Hospital

Nantou City, 540, Taiwan

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Pharmaceutical Services

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Health ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Pharmacist, Pharmacy Department, Nantou Hospital

Study Record Dates

First Submitted

October 14, 2011

First Posted

October 20, 2011

Study Start

August 1, 2011

Primary Completion

August 1, 2012

Last Updated

September 17, 2012

Record last verified: 2012-09

Locations