Quality of LifeREVORNCT03393299
Impact of the Systematic Use of the Criteria STOPP/START in Short Stay Geriatric.
A study testing STOPP/START criteria in people with Quality of Life and Drug Use, run by Lille Catholic University at 1 site in France.
Trial summary
Assess the impact of the systematic use of STOPP/START tool during medication conciliation on the evolution of hospitalised elderly people's quality of life at 2 months. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Quality of Life, Drug Use
- What is being tested?
- STOPP/START criteria
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jan 2018to 30 Oct 2018
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patient with more than 75 years old
- Hospitalized in geriatrics short-stay
- Patient with a written informed consent
- Patient with a social security scheme
Who cannot join
- Severe dementia
- Not able to respond to SF-12
- Disease at final stage
- Patient under legal protection (maintenance of justice, tutelage, legal guardianship)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of the Systematic Use of the Criteria STOPP/START in Short Stay Geriatric: Study of Superiority, Randomized, Controlled, Prospective, Single Blind
Assess the impact of the systematic use of STOPP/START tool during medication conciliation on the evolution of hospitalised elderly people's quality of life at 2 months.
- Conditions
- Quality of Life, Drug Use
- Being tested
- STOPP/START criteria
- Keywords
- elderly people, geriatric short-stay, STOPP/START criteria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STOPP/START criteriaProcedure or surgery
software which helps to do the drug reconciliation
| Study group | Role | What they receive |
|---|---|---|
| STOPP/START | Experimental | Use of STOPP/START criteria during medication reconciliation Receives: Procedure: STOPP/START criteria |
| CONTROL | No intervention | Medication reconciliation done as usual, without the consideration of the STOPP/START criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
SF-12 Quality of life scale
The evolution of the hospitalised elderly people's quality of life at 2 months will be measured by the SF-12 scale.
Measured: at inclusion and at 2 months
Secondary outcomes (3)
Number of falls
The number of falls during the two months following the inclusion will be collected for each patient.
Measured: at 2 months
Proportion of patients rehospitalized
The proportion of patients that have been rehospitalized (unscheduled hospitalization) during the two months following inclusion will be measured.
Measured: at 2 months
Mortality
The mortality during the two months following inclusion will be measured.
Measured: at 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study start16 Jan 2018
- Primary completion17 Jul 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03393299
- Sponsor's protocol ID
- RC-P0059
- Acronym
- REVOR
- Status last verified
- Aug 2020
- First submitted
- 2 Jan 2018
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Systematic Use of the Criteria STOPP/START in Short Stay Geriatric: Study of Superiority, Randomized, Controlled, Prospective, Single Blind
- ClinicalTrials.gov ID
- NCT03393299
- Acronym / sponsor ID
- REVOR / RC-P0059
- Conditions
- Quality of Life, Drug Use
- Keywords
- elderly people, geriatric short-stay, STOPP/START criteria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- 16 Jan 2018 (actual)
- Primary completion
- 17 Jul 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 8 Jan 2018 (actual)
- 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.
Assess the impact of the systematic use of STOPP/START tool during medication conciliation on the evolution of hospitalised elderly people's quality of life at 2 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STOPP/START | Experimental | Procedure: STOPP/START criteriaUse of STOPP/START criteria during medication reconciliation |
| CONTROL | No intervention | –Medication reconciliation done as usual, without the consideration of the STOPP/START criteria |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patient with more than 75 years old
- Hospitalized in geriatrics short-stay
- Patient with a written informed consent
- Patient with a social security scheme
Key exclusion criteria (4 listed)
- Severe dementia
- Not able to respond to SF-12
- Disease at final stage
- Patient under legal protection (maintenance of justice, tutelage, legal guardianship)
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 |
|---|---|---|
| STOPP/START criteriasoftware which helps to do the drug reconciliation | Procedure or surgery | STOPP/START |
Primary outcome
SF-12 Quality of life scale
Time frame: at inclusion and at 2 months
The evolution of the hospitalised elderly people's quality of life at 2 months will be measured by the SF-12 scale.
3 secondary outcomes
Number of falls
Time frame: at 2 months
Proportion of patients rehospitalized
Time frame: at 2 months
Mortality
Time frame: at 2 months
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 5 Aug 2020.
- Individual participant dataSharing planned: No
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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 STOPP/START criteria in people with Quality of Life and Drug Use, run by Lille Catholic University at 1 site in France.
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 4 inclusion and 4 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 5 Aug 2020. 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 France. 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?
SF-12 Quality of life scale (time frame: at inclusion and at 2 months). 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 5 Aug 2020.