Focus on the Elderly in a Nursing HomeNCT01823757
Pharmaceutical Care in VA Nursing Home
An observational study of Focus on the Elderly in a Nursing Home, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
This study investigates the effect of pharmaceutical care on a Veteran nursing home. 100 patients will be selected into this controlled study.The hypothesis are: 1. After patients receive pharmaceutical care, their drug related problems will be decreased. 2. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Focus on the Elderly in a Nursing Home
- What is being tested?
- Pharmaceutical care
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2013to Dec 2015
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Resident from a Veteran nursing home and willing to receive the pharmaceutical care by pharmacists.
Who may be able to join
- Residents in the Veteran nursing home
- Age over 65 years old
- Complete Comprehensive Geriatric Assessment (CGA)
- Use more than 4 drug item per day (excluding stat order)
- subjects with more than 2 chronic diseases.
Who cannot join
- subjects who were in pharmaceutical care project of Taiwan Pharmacist Association.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impacts of Pharmaceutical Cares on the Elderly in a VA Nursing Home.
This study investigates the effect of pharmaceutical care on a Veteran nursing home. 100 patients will be selected into this controlled study.The hypothesis are:
- After patients receive pharmaceutical care, their drug related problems will be decreased.
- After patients received pharmaceutical care, their self-reported medical expenditure will be decreased.
Read the detailed description
Around 200 residents in a Veteran nursing home will be selected for reviewing inclusion and exclusion criteria. A total of 100 subjected are selected into this randomized controlled trial. Each group will have 50 subjects and then divides into 4 subgroup, according to their drug items used (5-7 and over 8 items used).
The inclusion criteria:
- Residents of the Veteran nursing home.
- over 65 years old.
- complete comprehensive geriatric assessment (CGA)
- prescription drugs more than 4 times/day, excluding stat order.
- with 2 or more chronic diseases.
Exclusion criteria:
- residents who were in the pharmaceutical care project of Taiwan Pharmacists Association.
- Conditions
- Focus on the Elderly in a Nursing Home
- Being tested
- Pharmaceutical care
- Keywords
- elderly, potential inappropriate medications, pharmaceutical care, quality of life, medical expenditure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmaceutical careOther
pharmacists provide pharmaceutical care to the intervention group, comparing to ordinary care in control group
| Study group | Role | What they receive |
|---|---|---|
| Non-pharmaceutical care | Veterans do not receiving pharmaceutical care | |
| Pharmaceutical care | Veterans receiving pharmaceutical care Receives: Other: Pharmaceutical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
potential inappropriate medication (PIA)
Measured: one year
Secondary outcomes (2)
drug items used
the controlled group is expected to have less drug items used.
Measured: one year
medical expenditure
subjects self-reported outpatients visit, hospitalization, drug, and healthy supplemental used.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionJul 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus on the Elderly in a Nursing HomeStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wen-Shyong Liou, PhD, Principal investigator, Taichung Veteran General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01823757
- Sponsor's protocol ID
- VGHTCPHARMACY1
- Other IDs
- TCVGHPHARM_RESEARCH_1
- Status last verified
- Aug 2014
- First submitted
- 29 Mar 2013
- Last updated
- 28 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impacts of Pharmaceutical Cares on the Elderly in a VA Nursing Home.
- ClinicalTrials.gov ID
- NCT01823757
- Acronym / sponsor ID
- VGHTCPHARMACY1
- Conditions
- Focus on the Elderly in a Nursing Home
- Keywords
- elderly, potential inappropriate medications, pharmaceutical care, quality of life, medical expenditure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 4 Apr 2013 (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 study investigates the effect of pharmaceutical care on a Veteran nursing home. 100 patients will be selected into this controlled study.The hypothesis are:
- After patients receive pharmaceutical care, their drug related problems will be decreased.
- After patients received pharmaceutical care, their self-reported medical expenditure will be decreased.
Detailed description
Around 200 residents in a Veteran nursing home will be selected for reviewing inclusion and exclusion criteria. A total of 100 subjected are selected into this randomized controlled trial. Each group will have 50 subjects and then divides into 4 subgroup, according to their drug items used (5-7 and over 8 items used).
The inclusion criteria:
- Residents of the Veteran nursing home.
- over 65 years old.
- complete comprehensive geriatric assessment (CGA)
- prescription drugs more than 4 times/day, excluding stat order.
- with 2 or more chronic diseases.
Exclusion criteria:
- residents who were in the pharmaceutical care project of Taiwan Pharmacists Association.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-pharmaceutical care | – | –Veterans do not receiving pharmaceutical care |
| Pharmaceutical care | – | Other: Pharmaceutical careVeterans receiving pharmaceutical care |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Resident from a Veteran nursing home and willing to receive the pharmaceutical care by pharmacists.
Key inclusion criteria (5 listed)
- Residents in the Veteran nursing home
- Age over 65 years old
- Complete Comprehensive Geriatric Assessment (CGA)
- Use more than 4 drug item per day (excluding stat order)
- subjects with more than 2 chronic diseases.
Key exclusion criteria (1 listed)
- subjects who were in pharmaceutical care project of Taiwan Pharmacist Association.
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 carepharmacists provide pharmaceutical care to the intervention group, comparing to ordinary care in control group | Other | Pharmaceutical care |
Primary outcome
potential inappropriate medication (PIA)
Time frame: one year
2 secondary outcomes
drug items used
Time frame: one year
medical expenditure
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2014.
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.
Wen-Shyong Liou, PhD principal investigator
Taichung Veteran General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Focus on the Elderly in a Nursing Home, run by Taichung Veterans General 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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 28 Aug 2014. 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?
Results are not available in the source record.
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?
potential inappropriate medication (PIA) (time frame: one year). 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 28 Aug 2014.