Diabetes MellitusNCT01455727
Pharmaceutical Care of Ambulatory Elderly Diabetes Patients
A study testing Pharmaceutical care in people with Diabetes Mellitus, run by Nantou Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Pharmaceutical care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2011to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 years or older
- A1c greater than or equal to 9.0
Who cannot join
- Not expected to live for the duration of the study
- Unwillingness to participate and attend pharmacist visits
- Unwillingness to participate the questionnaires(MMSE, GDS)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Diabetes Mellitus
- Being tested
- Pharmaceutical care, Usual care
- Keywords
- Pharmaceutical care, Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmaceutical careOther
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.
Usual careOther
Control patients received usual care directed by their physician.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Pharmaceutical care |
| Usual care | Active comparator | Patients received usual care directed by their physician. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hgb A1c change
baseline, second measurement during 3 to 6 month after baseline, and the last measurement during 9 to 12 month after baseline
Measured: 12 month
Secondary outcomes (2)
Mini-Mental State Examination(MMSE) Score change
baseline and the second test was performed after 3 month.
Measured: 1 year
Taiwan Geriatric Depression Scale(GDS) Score change
baseline and the second test was performed after 3 month.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2011 (estimated)
- Study startAug 2011
- Primary completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantou Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jyun-Hong Chen, Nantou Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01455727
- Sponsor's protocol ID
- 100B4022-100MID-08
- Status last verified
- Sep 2012
- First submitted
- 14 Oct 2011
- Last updated
- 17 Sep 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmaceutical Care of Ambulatory Elderly Diabetes Patients
- ClinicalTrials.gov ID
- NCT01455727
- Acronym / sponsor ID
- 100B4022-100MID-08
- Conditions
- Diabetes Mellitus
- Keywords
- Pharmaceutical care, Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Nantou HospitalOther government
- Study start
- Aug 2011
- Primary completion
- Aug 2012 (actual)
- First posted
- 20 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmaceutical care | Experimental | Other: Pharmaceutical careThe 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. |
| Usual care | Active comparator | Other: Usual carePatients received usual care directed by their physician. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age 65 years or older
- A1c greater than or equal to 9.0
Key exclusion criteria (3 listed)
- Not expected to live for the duration of the study
- Unwillingness to participate and attend pharmacist visits
- Unwillingness to participate the questionnaires(MMSE, GDS)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmaceutical careThe 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 careControl patients received usual care directed by their physician. | Other | Usual care |
Primary outcome
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
2 secondary outcomes
Mini-Mental State Examination(MMSE) Score change
Time frame: 1 year
Taiwan Geriatric Depression Scale(GDS) Score change
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmaceutical care in people with Diabetes Mellitus, run by Nantou Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hgb A1c change (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2012.