Quality of LifeNCT04676984
Medication Use and Quality of Life Among Older People (Pilot)
A study testing Consultations in people with Quality of Life and Reduction, Harm, run by Odense University Hospital at 1 site in Denmark.
Trial summary
This project will provide new evidence on how to optimize medication use among older people with limited life expectancy. This will be done by testing whether a patient-centered deprescribing intervention, focused on aligning medical treatment with patients' preferences, can improve quality of life among older people… Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Quality of Life, Reduction, Harm
- What is being tested?
- Consultations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2020to 8 Jul 2021
- 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 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged ≥80 years
- Take ≥8 different medications
- Have a life expectancy of <2 years, estimated via the Surprise Question ("Would you be surprised if this patient died within 1-2 years?") by the general practitioner
- Have a Mini-Mental State Exam (MMSE) score of ≥15
- Are able to provide informed consent
Who cannot join
- Not able to communicate
- Does not speak and understand Danish
Trial locations and contacts
1 site in 1 country.
About this study
This project will provide new evidence on how to optimize medication use among older people with limited life expectancy. This will be done by testing whether a patient-centered deprescribing intervention, focused on aligning medical treatment with patients' preferences, can improve quality of life among older people with limited life expectancy. This registration concerns the initial pilot study.
Read the detailed description
In a pragmatic randomized controlled trial, this project will test whether a comprehensive and patient-centered deprescribing intervention can improve quality of life among older people with limited life expectancy. This registration concerns the initial pilot study. All patients included in the pilot study will receive the intervention (that is, the pilot study will not include randomization).
The intervention will comprise a series of consultations between the patient and general practitioner (GP) (at least three) to continuously adjust the patient's medication according to the patient's goals, needs, and preferences, thereby ensuring alignment with the patient's priorities. Thus, the purpose of this intervention is to initiate and facilitate a continued deprescribing process. The process can be summarized in seven steps: During an initial consultation (1: Consultation 0), the GP assesses patient eligibility. If the patient would like to participate, a project nurse subsequently visits the patient at home (2: Home visit) for retrieval of informed consent as well as baseline measurements. During the next consultation (3: Consultation 1), the patient and GP discuss how the patient feels about his/her medical treatment, and the GP provides the patient with written material for the patient to prepare prior to the next consultation. The patients prepares (4: Preparation) by considering and verbalizing his/her goals of care and treatment preferences. Simultaneously, a clinical pharmacist examines the patient's medication list and provides suggestions to the GP on which drugs can be continued and deprescribed, respectively. During the next consultation (5: Consultation 2), the patient and GP discuss the patient's preferences and initiate deprescribing initiatives aligned with the patient's priorities. During a new consultation (6: Consultation 3), the patient and GP follow up on the changes initiated and initiate new deprescribing initiatives if such can be identified. If needed, subsequent consultations (7: Consultation X) are planned until the patient and GP consider the patient's medical treatment optimal.
- Conditions
- Quality of Life, Reduction, Harm
- Being tested
- Consultations
- Keywords
- Deprescribing, Polypharmacy, Guideline
- Medical subject headings
- Harm Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConsultationsOther
The intervention will comprise a series of consultations between the patient and general practitioner (at least three), where the patient and general practitioner will continuously adjust the patient's medication according to the patient's goals, needs, and preferences.
| Study group | Role | What they receive |
|---|---|---|
| Consultations | Other | The intervention will comprise a series of consultations between the patient and general practitioner (at least three), where the patient and general practitioner will continuously adjust the patient's medication according to the patient's goals, needs, and preferences. Receives: Other: Consultations |
What is being measured
The primary outcome is the main question the study is designed to answer.
HEALTH-RELATED QUALITY OF LIFE
Health-related quality of life will be measured using the Danish version of the SF-12v2 Health Survey.
Measured: Baseline
CHANGE FROM BASELINE HEALTH-RELATED QUALITY OF LIFE AT 3 MONTHS
Health-related quality of life will be measured using the Danish version of the SF-12v2 Health Survey.
Measured: 3 months
CHANGE FROM BASELINE HEALTH-RELATED QUALITY OF LIFE AT 6 MONTHS
Health-related quality of life will be measured using the Danish version of the SF-12v2 Health Survey.
Measured: 6 months
HEALTH-RELATED QUALITY OF LIFE (DEPRESSION)
Health-related quality of life will be measured using the Danish version of the Depression List.
Measured: Baseline
CHANGE FROM BASELINE HEALTH-RELATED QUALITY OF LIFE (DEPRESSION) AT 3 MONTHS
Health-related quality of life will be measured using the Danish version of the Depression List.
Measured: 3 months
CHANGE FROM BASELINE HEALTH-RELATED QUALITY OF LIFE (DEPRESSION) AT 6 MONTHS
Health-related quality of life will be measured using the Danish version of the Depression List.
Measured: 6 months
MORTALITY
Mortality will be assessed through the nationwide Danish Central Person Registry.
Measured: 3 months
MORTALITY
Mortality will be assessed through the nationwide Danish Central Person Registry.
Measured: 6 months
MORTALITY
Mortality will be assessed through the nationwide Danish Central Person Registry.
Measured: 12 months
Secondary outcomes (9)
COGNITIVE FUNCTION
Cognitive function will be measured using the Danish version of the Mini-Mental State Examination-2 (MMSE-2) Standard Form.
Measured: Baseline, 3 months and 6 months
FUNCTIONAL LEVEL
Functional level will be measured using the Danish version of the Vulnerable Elders Survey 13 (VES-13).
Measured: Baseline, 3 months and 6 months
HAND-GRIP STRENGTH
Hand-grip strength will be measured using a hand-grip dynamometer.
Measured: Baseline, 3 months and 6 months
ABILITY TO SIT AND STAND
Ability to sit and stand will be measured via the 30-second stand-sit-test.
Measured: Baseline, 3 months and 6 months
NUMBER OF MEDICATIONS DISCONTINUED
Number of medications dicontinued will be assessed through the medication lists.
Measured: 3 months, 6 months and 12 months
NUMBER OF MEDICATION CHANGES
Number of medication changes will be assessed through the medication lists.
Measured: 3 months, 6 months and 12 months
HOSPITAL ADMISSIONS
Admissions will be assessed through the nationwide Danish National Patient Register.
Measured: 3 months, 6 months and 12 months
HEALTH CARE COSTS
Health care costs.
Measured: 3 months, 6 months and 12 months
SUCCESS RATE OF THE INTERVENTION
Succes rate of the intervention.
Measured: 3 months, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start1 Jun 2020
- Primary completion12 Apr 2021
- Study completion8 Jul 2021
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.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark
- Responsible party
- Principal investigator, Carina Lundby, Odense University Hospital
- Investigators
- Anton Pottegård, Prof, Principal investigator, apottegaard@health.sdu.dk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04676984
- Sponsor's protocol ID
- ODIN-1 Pilot
- Status last verified
- Apr 2022
- First submitted
- 1 Dec 2020
- Last updated
- 26 Apr 2022
- Results posted
- 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 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication Use and Quality of Life Among Older People (Pilot)
- ClinicalTrials.gov ID
- NCT04676984
- Acronym / sponsor ID
- ODIN-1 Pilot
- Conditions
- Quality of Life, Reduction, Harm
- Keywords
- Deprescribing, Polypharmacy, Guideline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- University of Southern Denmark
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 12 Apr 2021 (actual)
- Study completion
- 8 Jul 2021 (actual)
- First posted
- 21 Dec 2020 (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.
This project will provide new evidence on how to optimize medication use among older people with limited life expectancy. This will be done by testing whether a patient-centered deprescribing intervention, focused on aligning medical treatment with patients' preferences, can improve quality of life among older people with limited life expectancy. This registration concerns the initial pilot study.
Detailed description
In a pragmatic randomized controlled trial, this project will test whether a comprehensive and patient-centered deprescribing intervention can improve quality of life among older people with limited life expectancy. This registration concerns the initial pilot study. All patients included in the pilot study will receive the intervention (that is, the pilot study will not include randomization).
The intervention will comprise a series of consultations between the patient and general practitioner (GP) (at least three) to continuously adjust the patient's medication according to the patient's goals, needs, and preferences, thereby ensuring alignment with the patient's priorities. Thus, the purpose of this intervention is to initiate and facilitate a continued deprescribing process. The process can be summarized in seven steps: During an initial consultation (1: Consultation 0), the GP assesses patient eligibility. If the patient would like to participate, a project nurse subsequently visits the patient at home (2: Home visit) for retrieval of informed consent as well as baseline measurements. During the next consultation (3: Consultation 1), the patient and GP discuss how the patient feels about his/her medical treatment, and the GP provides the patient with written material for the patient to prepare prior to the next consultation. The patients prepares (4: Preparation) by considering and verbalizing his/her goals of care and treatment preferences. Simultaneously, a clinical pharmacist examines the patient's medication list and provides suggestions to the GP on which drugs can be continued and deprescribed, respectively. During the next consultation (5: Consultation 2), the patient and GP discuss the patient's preferences and initiate deprescribing initiatives aligned with the patient's priorities. During a new consultation (6: Consultation 3), the patient and GP follow up on the changes initiated and initiate new deprescribing initiatives if such can be identified. If needed, subsequent consultations (7: Consultation X) are planned until the patient and GP consider the patient's medical treatment optimal.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Consultations | Other | Other: ConsultationsThe intervention will comprise a series of consultations between the patient and general practitioner (at least three), where the patient and general practitioner will continuously adjust the patient's medication according to the patient's goals, needs, and preferences. |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Aged ≥80 years
- Take ≥8 different medications
- Have a life expectancy of <2 years, estimated via the Surprise Question ("Would you be surprised if this patient died within 1-2 years?") by the general practitioner
- Have a Mini-Mental State Exam (MMSE) score of ≥15
- Are able to provide informed consent
Key exclusion criteria (2 listed)
- Not able to communicate
- Does not speak and understand Danish
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 |
|---|---|---|
| ConsultationsThe intervention will comprise a series of consultations between the patient and general practitioner (at least three), where the patient and general practitioner will continuously adjust the patient's medication according to the patient's goals, needs, and preferences. | Other | Consultations |
Primary outcome
HEALTH-RELATED QUALITY OF LIFE
Time frame: Baseline
Health-related quality of life will be measured using the Danish version of the SF-12v2 Health Survey.
CHANGE FROM BASELINE HEALTH-RELATED QUALITY OF LIFE AT 3 MONTHS
Time frame: 3 months
Health-related quality of life will be measured using the Danish version of the SF-12v2 Health Survey.
CHANGE FROM BASELINE HEALTH-RELATED QUALITY OF LIFE AT 6 MONTHS
Time frame: 6 months
Health-related quality of life will be measured using the Danish version of the SF-12v2 Health Survey.
HEALTH-RELATED QUALITY OF LIFE (DEPRESSION)
Time frame: Baseline
Health-related quality of life will be measured using the Danish version of the Depression List.
CHANGE FROM BASELINE HEALTH-RELATED QUALITY OF LIFE (DEPRESSION) AT 3 MONTHS
Time frame: 3 months
Health-related quality of life will be measured using the Danish version of the Depression List.
CHANGE FROM BASELINE HEALTH-RELATED QUALITY OF LIFE (DEPRESSION) AT 6 MONTHS
Time frame: 6 months
Health-related quality of life will be measured using the Danish version of the Depression List.
MORTALITY
Time frame: 3 months
Mortality will be assessed through the nationwide Danish Central Person Registry.
MORTALITY
Time frame: 6 months
Mortality will be assessed through the nationwide Danish Central Person Registry.
MORTALITY
Time frame: 12 months
Mortality will be assessed through the nationwide Danish Central Person Registry.
9 secondary outcomes
COGNITIVE FUNCTION
Time frame: Baseline, 3 months and 6 months
FUNCTIONAL LEVEL
Time frame: Baseline, 3 months and 6 months
HAND-GRIP STRENGTH
Time frame: Baseline, 3 months and 6 months
ABILITY TO SIT AND STAND
Time frame: Baseline, 3 months and 6 months
NUMBER OF MEDICATIONS DISCONTINUED
Time frame: 3 months, 6 months and 12 months
NUMBER OF MEDICATION CHANGES
Time frame: 3 months, 6 months and 12 months
HOSPITAL ADMISSIONS
Time frame: 3 months, 6 months and 12 months
HEALTH CARE COSTS
Time frame: 3 months, 6 months and 12 months
SUCCESS RATE OF THE INTERVENTION
Time frame: 3 months, 6 months and 12 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 26 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Quality of Life
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Study of a Support Program for Quality of Life in Chinese Cancer Patients and Survivors
Cancer, Survivorship
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
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.
Anton Pottegård, Prof principal investigator
apottegaard@health.sdu.dk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Consultations in people with Quality of Life and Reduction, Harm, run by Odense University Hospital at 1 site in Denmark.
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 2 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 26 Apr 2022. 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 Denmark. 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?
HEALTH-RELATED QUALITY OF LIFE (time frame: Baseline). The study lists 9 primary outcomes in all. 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 26 Apr 2022.