Frail Elderly SyndromeNCT03591055
Frailty Assessment and Treatment Strategies in the Elderly at Risk of Functional Decline in the Community
A study testing CGA, medication review, exercise and cognitive stimulation in people with Frail Elderly Syndrome, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
This study aims to design a patient -centered program to prevent or delay frailty , functional decline and adverse events, and evaluates the effectiveness of the program with a randomized clinical trial. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frail Elderly Syndrome
- What is being tested?
- CGA, medication review, exercise and cognitive stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 1 Aug 2018to 31 Dec 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Positive screen in the accumulation of deficits electronic frailty index
- Positive screen with Gerontopole screening tool and/or RISC tool
Who cannot join
- Living in an institution
- Advanced conditions with short life expectancy
- Severe disability
- Severe Dementia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Frailty Assessment and Multimodal Treatment Strategies in the Elderly at Risk of Adverse Results and Functional Decline in the Community
This study aims to design a patient -centered program to prevent or delay frailty , functional decline and adverse events, and evaluates the effectiveness of the program with a randomized clinical trial.
Read the detailed description
Objective: To design and evaluate the implementation and impact of a multimodal intervention focused on elderly patients living in the community in preventing or delaying frailty, functional decline and risk of institutionalization, hospitalization and death.
Design: Study in two phases: a qualitative study to develop the intervention and a randomized clinical trial with parallel arms and control group.
Intervention: Participants in the control group will receive the usual standard care and regular referrals. Patients in the intervention group will be first derived to a nurse case manager for initial application of a comprehensive geriatric assessment (CGA). Then patient-centered interventions will be prescribed, according to the different target areas identified in the geriatric assessment, along with medication review, aerobics exercise plan and memory workshops following the model adapted in Phase I.
After 3 and 18 months, measures of functional and cognitive performance, quality of life, frailty, adverse outcomes (institutionalization, hospitalization, death) and health care costs will be collected.
- Conditions
- Frail Elderly Syndrome
- Being tested
- CGA, medication review, exercise and cognitive stimulation
- Keywords
- Frail elderly, Clinical Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGA, medication review, exercise and cognitive stimulationOther
Comprehensive geriatric assessment. Patient-centered interventions according to the different target areas identified in the geriatric assessment. Medication review. Groupal Exercise plan and memory workshops.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Patients in the intervention group will be first derived to a nurse case manager for initial application of a comprehensive geriatric assessment. Then patient-centered interventions will be prescribed, according to the different target areas identified in the geriatric assessment. All participants in the intervention group will undergo a medication review and will also perform an aerobics exercise plan in the primary care centre, 60-minute session twice a week on non-consecutive days for 6 weeks (12 sessions of 60 minutes each) and memory workshops (10 sessions). Receives: Other: CGA, medication review, exercise and cognitive stimulation |
| Control group | No intervention | Participants in the control group will receive the usual standard care and regular referrals. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Short Physical Performance Battery (SPPB) at 3 and 18 months
The Short Physical Performance Battery (SPPB) is a standardised assessment tool of lower limb function, testing 3 dimensions: standing balance, walking speed, and chair stands. Each component is scored between 0-4, total score from 0 (poor performance) to 12 (best performance).
Measured: 0, 3, 18 months
Change from Baseline in the Quick Mild Cognitive Impairment Screen (Qmci-S) at 3 and 18 months
The Quick Mild Cognitive Impairment (Qmci) screen is a multi-purpose, short cognitive screening instrument designed to differentiate between normal cognitive function, subjective cognitive disorders, mild cognitive impairment (MCI) and early dementia and to measure change over time.
Measured: 0, 3, 18 months
Change from Baseline in Health Related Quality of Life (EuroQol 5D) at 3 and 18 months
EuroQol 5D EQ-5D is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal.
Measured: 0, 3, 18 months
Secondary outcomes (4)
Change from Baseline in Functional Capacity at 3 and 18 months
Activities of daily living: Barthel Index and Lawton\&Brody Index
Measured: 0, 3, 18 months
Change from Baseline in the Risk Instrument for Screening in the Community (RISC) at 3 and 18 months
Risk Instrument for Screening in the Community is a validated short (2-5 min), global subjective assessment of risk created to identify patients' 1-year risk of three outcomes: institutionalization, hospitalization and death.
Measured: 0, 3, 18 months
Change from Baseline in Clinical Frailty Scale (CFS) at 3 and 18 months
The clinical frailty scale is a 9 points measure of frailty based on clinical judgement.
Measured: 0,3 18 months
Change from Baseline in the Gerontopole Frailty Screening Tool (GFST) at 3 and 18 months
Gerontopole Frailty Screening Tool is a questionnaire aimed to measure general signs and/or symptoms potentially indicating the presence of an underlying frailty. These questions largely mirror the criteria that are commonly used to operationalize the frailty status.
Measured: 0,3,18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start1 Aug 2018
- Primary completion30 Jan 2020
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail Elderly SyndromeStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Català de la Salut, Instituto de Salud Carlos III
- Responsible party
- Sponsor
- Investigators
- FRANCISCO Orfila Pernas, Principal investigator, Institut Catala de Salut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03591055
- Sponsor's protocol ID
- PI16/01683
- Status last verified
- Aug 2022
- First submitted
- 22 Jun 2018
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frailty Assessment and Multimodal Treatment Strategies in the Elderly at Risk of Adverse Results and Functional Decline in the Community
- ClinicalTrials.gov ID
- NCT03591055
- Acronym / sponsor ID
- PI16/01683
- Conditions
- Frail Elderly Syndrome
- Keywords
- Frail elderly, Clinical Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Institut Català de la Salut, Instituto de Salud Carlos III
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 18 Jul 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.
This study aims to design a patient -centered program to prevent or delay frailty , functional decline and adverse events, and evaluates the effectiveness of the program with a randomized clinical trial.
Detailed description
Objective: To design and evaluate the implementation and impact of a multimodal intervention focused on elderly patients living in the community in preventing or delaying frailty, functional decline and risk of institutionalization, hospitalization and death.
Design: Study in two phases: a qualitative study to develop the intervention and a randomized clinical trial with parallel arms and control group.
Intervention: Participants in the control group will receive the usual standard care and regular referrals. Patients in the intervention group will be first derived to a nurse case manager for initial application of a comprehensive geriatric assessment (CGA). Then patient-centered interventions will be prescribed, according to the different target areas identified in the geriatric assessment, along with medication review, aerobics exercise plan and memory workshops following the model adapted in Phase I.
After 3 and 18 months, measures of functional and cognitive performance, quality of life, frailty, adverse outcomes (institutionalization, hospitalization, death) and health care costs will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: CGA, medication review, exercise and cognitive stimulationPatients in the intervention group will be first derived to a nurse case manager for initial application of a comprehensive geriatric assessment. Then patient-centered interventions will be prescribed, according to the different target areas identified in the geriatric assessment. All participants in the intervention group will undergo a medication review and will also perform an aerobics exercise plan in the primary care centre, 60-minute session twice a week on non-consecutive days for 6 weeks (12 sessions of 60 minutes each) and memory workshops (10 sessions). |
| Control group | No intervention | –Participants in the control group will receive the usual standard care and regular referrals. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Positive screen in the accumulation of deficits electronic frailty index
- Positive screen with Gerontopole screening tool and/or RISC tool
Key exclusion criteria (4 listed)
- Living in an institution
- Advanced conditions with short life expectancy
- Severe disability
- Severe Dementia
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 |
|---|---|---|
| CGA, medication review, exercise and cognitive stimulationComprehensive geriatric assessment. Patient-centered interventions according to the different target areas identified in the geriatric assessment. Medication review. Groupal Exercise plan and memory workshops. | Other | Intervention Group |
Primary outcome
Change from Baseline in Short Physical Performance Battery (SPPB) at 3 and 18 months
Time frame: 0, 3, 18 months
The Short Physical Performance Battery (SPPB) is a standardised assessment tool of lower limb function, testing 3 dimensions: standing balance, walking speed, and chair stands. Each component is scored between 0-4, total score from 0 (poor performance) to 12 (best performance).
Change from Baseline in the Quick Mild Cognitive Impairment Screen (Qmci-S) at 3 and 18 months
Time frame: 0, 3, 18 months
The Quick Mild Cognitive Impairment (Qmci) screen is a multi-purpose, short cognitive screening instrument designed to differentiate between normal cognitive function, subjective cognitive disorders, mild cognitive impairment (MCI) and early dementia and to measure change over time.
Change from Baseline in Health Related Quality of Life (EuroQol 5D) at 3 and 18 months
Time frame: 0, 3, 18 months
EuroQol 5D EQ-5D is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal.
4 secondary outcomes
Change from Baseline in Functional Capacity at 3 and 18 months
Time frame: 0, 3, 18 months
Change from Baseline in the Risk Instrument for Screening in the Community (RISC) at 3 and 18 months
Time frame: 0, 3, 18 months
Change from Baseline in Clinical Frailty Scale (CFS) at 3 and 18 months
Time frame: 0,3 18 months
Change from Baseline in the Gerontopole Frailty Screening Tool (GFST) at 3 and 18 months
Time frame: 0,3,18 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 1 Sep 2022.
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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.
FRANCISCO Orfila Pernas principal investigator
Institut Catala de Salut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CGA, medication review, exercise and cognitive stimulation in people with Frail Elderly Syndrome, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
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 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 1 Sep 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 Spain. 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?
Change from Baseline in Short Physical Performance Battery (SPPB) at 3 and 18 months (time frame: 0, 3, 18 months). The study lists 3 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 1 Sep 2022.