Frail ElderlyNCT01969526
Effectiveness of a Multifactorial Intervention on Frailty
A study testing Multifactorial intervention in people with Frail Elderly and Cognitive Impairment, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
Objective: To evaluate the effectiveness of a multifactorial intervention program based on physical activity and diet, memory workshops and review of medication, to modify frailty parameters, muscle strength and physical and cognitive performance in people 65 years or older with a positive screening for frailty. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frail Elderly, Cognitive Impairment, Dependence
- What is being tested?
- Multifactorial intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2013to 30 Sep 2017
- 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 Barber screen
- Timed get-up-and-go 10 to 20 seconds
- cognitive Lobo test greater than or equal to 18
Who cannot join
- Home Care
- Institutionalization
- Conditions not allowing physical exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Multifactorial Intervention to Modify Frailty Parameters in Elderly Population
Objective: To evaluate the effectiveness of a multifactorial intervention program based on physical activity and diet, memory workshops and review of medication, to modify frailty parameters, muscle strength and physical and cognitive performance in people 65 years or older with a positive screening for frailty. Secondly, to assess changes in falls, hospitalizations, nutritional risk, disability and institutionalization or home-care.
Methods: randomized clinical trial with a control group, of one year and a half of follow-up, conducted in eight primary care teams in Barcelona. Individuals to be included are 65 years or older with positive frailty screening, timed get-up-and-go between 10 to 30 seconds, and cognitive Lobo test greater than or equal to 18. 165 patients will be selected in each group (difference to be detected on physical performance (Short physical performance battery (SPPB)): 0.5 units; common Standard Deviation : 1.42, 20% lost to follow-up).
Read more
Intervention: consists in three different actions on frailty dimensions, applied to each subject in the intervention group, in groups of 15 participants: rehabilitative therapy plus intake of hyperproteic shakes, memory workshop and review of the medication.
Evaluations will be blinded and conducted at 0, 3 and 18 months. Analysis of variance for repeated measures to adjust for differences attributable to intervention effect and for potential confounders such as comorbidity, sensory limitations, social risk, other medical or social interventions, among others.
- Conditions
- Frail Elderly, Cognitive Impairment, Dependence
- Being tested
- Multifactorial intervention
- Keywords
- Frail elderly
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifactorial interventionOther
Also called Multifactorial intervention on frailty dimensions
Intervention consists in three different actions on frailty dimensions, applied to each subject in the intervention group, in groups of 15 participants: rehabilitative therapy and physical exercise plus intake of hyperproteic shakes, memory workshop and review of the medication.
| Study group | Role | What they receive |
|---|---|---|
| Multifactorial Intervention | Experimental | Intervention consists in three different actions on frailty dimensions, applied to each subject in the intervention group, in groups of 15 participants: rehabilitative therapy plus intake of hyperproteic shakes, memory workshop and review of the medication. Receives: Other: Multifactorial intervention |
| No intervention | No intervention | Usual care |
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 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 Muscle strength at 3 and 18 months
Evaluation of upper extremities strength was assessed through the measurement of force with a handgrip dynamometer. Grip strength was evaluated using a portable hand dynamometer (JAMAR®0-90 kg, coding 506320). The participants were seated with their shoulder in a neutral position and their elbow flexed at 90°. Three attempts were performed alternately in each hand; the mean of the three measures was recorded.
Measured: 0,3,18 months
Change from Baseline in Cognitive Performance (Barcelona test) at 3 and 18 months
The first neuro-psychometric instrument developed in Spain to measure semi-quantitatively cognitive status in clinical neurology was the Barcelona Test (BT). Shortened version of the BT, named Barcelona Test Review (BTR) had been used for neuropsychological area evaluation in our participants and it takes only 20-30 minutes to administer
Measured: 0,3,18 months
Secondary outcomes (5)
Number of Participants with Falls during follow-up, at 18 months
Measured: 18 months
Change from Baseline in Functional Capacity at 18 months
Barthel Index Lawton\&Brody Index
Measured: 18 months
Number of Participants Hospitalized during follow-up, at 18 months
Measured: 18 months
Number of Participants Institutionalized during follow-up, at 18 months
Measured: 18 months
Number of Participants included in Home Health care during follow-up, at 18 months
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2016
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Frail ElderlyStudies 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
- Outcomes assessor
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Carlos III Health Institute
- Responsible party
- Sponsor
- Investigators
- Josep Maria segura, MD, Phd, Principal investigator, Jordi Gol Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01969526
- Sponsor's protocol ID
- PI12/01503
- Status last verified
- Mar 2017
- First submitted
- 1 Aug 2013
- Last updated
- 13 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Romera L, Orfila F, Segura JM, Ramirez A, Moller M, Fabra ML, Lancho S, Bastida N, Foz G, Fabregat MA, Marti N, Cullell M, Martinez D, Gine M, Bistuer A, Cendros P, Perez E. Effectiveness of a primary care based multifactorial intervention to improve frailty parameters in the elderly: a randomised clinical trial: rationale and study design. BMC Geriatr. 2014 Nov 27;14:125. doi: 10.1186/1471-2318-14-125.
PubMed 25427568
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Multifactorial Intervention to Modify Frailty Parameters in Elderly Population
- ClinicalTrials.gov ID
- NCT01969526
- Acronym / sponsor ID
- PI12/01503
- Conditions
- Frail Elderly, Cognitive Impairment, Dependence
- Keywords
- Frail elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Carlos III Health Institute
- Study start
- Jan 2013 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 25 Oct 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.
Objective: To evaluate the effectiveness of a multifactorial intervention program based on physical activity and diet, memory workshops and review of medication, to modify frailty parameters, muscle strength and physical and cognitive performance in people 65 years or older with a positive screening for frailty. Secondly, to assess changes in falls, hospitalizations, nutritional risk, disability and institutionalization or home-care.
Methods: randomized clinical trial with a control group, of one year and a half of follow-up, conducted in eight primary care teams in Barcelona. Individuals to be included are 65 years or older with positive frailty screening, timed get-up-and-go between 10 to 30 seconds, and cognitive Lobo test greater than or equal to 18. 165 patients will be selected in each group (difference to be detected on physical performance (Short physical performance battery (SPPB)): 0.5 units; common Standard Deviation : 1.42, 20% lost to follow-up).
Intervention: consists in three different actions on frailty dimensions, applied to each subject in the intervention group, in groups of 15 participants: rehabilitative therapy plus intake of hyperproteic shakes, memory workshop and review of the medication.
Evaluations will be blinded and conducted at 0, 3 and 18 months. Analysis of variance for repeated measures to adjust for differences attributable to intervention effect and for potential confounders such as comorbidity, sensory limitations, social risk, other medical or social interventions, among others.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multifactorial Intervention | Experimental | Other: Multifactorial interventionIntervention consists in three different actions on frailty dimensions, applied to each subject in the intervention group, in groups of 15 participants: rehabilitative therapy plus intake of hyperproteic shakes, memory workshop and review of the medication. |
| No intervention | No intervention | –Usual care |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Positive Barber screen
- Timed get-up-and-go 10 to 20 seconds
- cognitive Lobo test greater than or equal to 18
Key exclusion criteria (3 listed)
- Home Care
- Institutionalization
- Conditions not allowing physical exercise
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 |
|---|---|---|
| Multifactorial interventionAlso: Multifactorial intervention on frailty dimensionsIntervention consists in three different actions on frailty dimensions, applied to each subject in the intervention group, in groups of 15 participants: rehabilitative therapy and physical exercise plus intake of hyperproteic shakes, memory workshop and review of the medication. | Other | Multifactorial Intervention |
Primary outcome
Change from Baseline in Short Physical performance battery 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 Muscle strength at 3 and 18 months
Time frame: 0,3,18 months
Evaluation of upper extremities strength was assessed through the measurement of force with a handgrip dynamometer. Grip strength was evaluated using a portable hand dynamometer (JAMAR®0-90 kg, coding 506320). The participants were seated with their shoulder in a neutral position and their elbow flexed at 90°. Three attempts were performed alternately in each hand; the mean of the three measures was recorded.
Change from Baseline in Cognitive Performance (Barcelona test) at 3 and 18 months
Time frame: 0,3,18 months
The first neuro-psychometric instrument developed in Spain to measure semi-quantitatively cognitive status in clinical neurology was the Barcelona Test (BT). Shortened version of the BT, named Barcelona Test Review (BTR) had been used for neuropsychological area evaluation in our participants and it takes only 20-30 minutes to administer
5 secondary outcomes
Number of Participants with Falls during follow-up, at 18 months
Time frame: 18 months
Change from Baseline in Functional Capacity at 18 months
Time frame: 18 months
Number of Participants Hospitalized during follow-up, at 18 months
Time frame: 18 months
Number of Participants Institutionalized during follow-up, at 18 months
Time frame: 18 months
Number of Participants included in Home Health care during follow-up, at 18 months
Time frame: 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 13 Nov 2017.
- Background: PubMed 25427568Romera L, Orfila F, Segura JM, Ramirez A, Moller M, Fabra ML, Lancho S, Bastida N, Foz G, Fabregat MA, Marti N, Cullell M, Martinez D, Gine M, Bistuer A, Cendros P, Perez E. Effectiveness of a primary care based multifactorial intervention to improve frailty parameters in the elderly: a randomised clinical trial: rationale and study design. BMC Geriatr. 2014 Nov 27;14:125. doi: 10.1186/1471-2318-14-125.
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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.
Josep Maria segura, MD, Phd principal investigator
Jordi Gol Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multifactorial intervention in people with Frail Elderly and Cognitive Impairment, 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 3 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 13 Nov 2017. 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 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?
On the ClinicalTrials.gov record for NCT01969526, which also lists 1 linked publication.
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 13 Nov 2017.