Pre-frailNCT02138968
Clinical and Economic Assessment of a Pre-frail Screening Program
A study testing Multidisciplinary intervention in people with Pre-frail and Elderly, run by Consorci Sanitari del Maresme at 1 site in Spain.
Trial summary
The study intervention improves functional capacity and delays frailty status in pre-frail elderly subjects. Read more about this study
- Who is it for?
- Ages 70 years and older
- What is being tested?
- Multidisciplinary intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2013to Aug 2015
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- More than 70 years consulting in primary care
- Non institutionalized
- Pre-frailty according to L.Fried criteria (1 or 2 criteria)
- Signed informed consent
Who cannot join
- Patient not able to stand by himself/herself
- Dementia
- Palliative care or life expectancy less than 6 months
- Blind patient
- unstable clinical situation
- Participation in other programs, studies or trials for elderly people
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Economic Assessment of an Opportunistic Screening Program for Pre-frailty State in Elderly Population.
The study intervention improves functional capacity and delays frailty status in pre-frail elderly subjects.
- Being tested
- Multidisciplinary intervention
- Keywords
- Pre-frailty, Frail, Exercise, Nutritional assessment, Functional capacity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary interventionOther
Multidimensional intervention based on: good control of baseline diseases, review of medication adequacy, exercise program, nutritional assessment and control, social assessment and control.
| Study group | Role | What they receive |
|---|---|---|
| Multidimensional intervention | Experimental | Multidimensional intervention based on: good control of baseline diseases, review of medication adequacy, exercise program, nutritional assessment and control, social assessment and control. Receives: Other: Multidisciplinary intervention |
| Usual care | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frailty according to L.Fried criteria (questionnaire).
L.Fried frailty criteria: (Robust: 0 criteria; Pre-frail: 1-2 criteria; Frail: >=3 criteria)
- Weight loss
- Fatigue
- Poor physical activity
- Low walking speed
- Low muscle strength Reference of L.Fried: J Gerontol A Biol Sci Med Sci. 2001 Mar; 56(3):M146-56. PMID: 11253156.
Measured: One year
Functional capacity according to Barthel score and Timed up and go test.
Barthel score and Timed up and go test.
Measured: One year
Secondary outcomes (4)
Nutritional status according to MNA-sf.
Mini Nutritional Assessment short form (MNA-sf).
Measured: One year
Quality of live according to EuroQoL.
EuroQoL.
Measured: One year
Mortality
Measured: One year
Health resource consumption (composite measure)
Number of visits to primary care center, number of visits to hospital emergency department, number of hospitalizations, days of hospital stay, institutionalization to nursing homes, visits to nutritionist and visits to social services.
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 posted15 May 2014 (estimated)
- Study startSep 2013
- Primary completionAug 2015
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 Pre-frailStudies 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
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari del Maresme
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mateu Serra-Prat, PhD, Principal investigator, Fundació Salut del Consorci Sanitari del Maresme
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02138968
- Sponsor's protocol ID
- 17/13
- Other IDs
- CEIC 17/13
- Status last verified
- Aug 2015
- First submitted
- 12 May 2014
- Last updated
- 1 Sep 2015
- Results posted
- No
Publications
Serra-Prat M, Sist X, Domenich R, Jurado L, Saiz A, Roces A, Palomera E, Tarradelles M, Papiol M. Effectiveness of an intervention to prevent frailty in pre-frail community-dwelling older people consulting in primary care: a randomised controlled trial. Age Ageing. 2017 May 1;46(3):401-407. doi: 10.1093/ageing/afw242.
PubMed 28064172
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Economic Assessment of an Opportunistic Screening Program for Pre-frailty State in Elderly Population.
- ClinicalTrials.gov ID
- NCT02138968
- Acronym / sponsor ID
- 17/13
- Keywords
- Pre-frailty, Frail, Exercise, Nutritional assessment, Functional capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Consorci Sanitari del MaresmeUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Aug 2015 (actual)
- First posted
- 15 May 2014 (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.
The study intervention improves functional capacity and delays frailty status in pre-frail elderly subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multidimensional intervention | Experimental | Other: Multidisciplinary interventionMultidimensional intervention based on: good control of baseline diseases, review of medication adequacy, exercise program, nutritional assessment and control, social assessment and control. |
| Usual care | No intervention | –Usual care |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- More than 70 years consulting in primary care
- Non institutionalized
- Pre-frailty according to L.Fried criteria (1 or 2 criteria)
- Signed informed consent
Key exclusion criteria (6 listed)
- Patient not able to stand by himself/herself
- Dementia
- Palliative care or life expectancy less than 6 months
- Blind patient
- unstable clinical situation
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 |
|---|---|---|
| Multidisciplinary interventionMultidimensional intervention based on: good control of baseline diseases, review of medication adequacy, exercise program, nutritional assessment and control, social assessment and control. | Other | Multidimensional intervention |
Primary outcome
Frailty according to L.Fried criteria (questionnaire).
Time frame: One year
L.Fried frailty criteria: (Robust: 0 criteria; Pre-frail: 1-2 criteria; Frail: >=3 criteria) 1. Weight loss 2. Fatigue 3. Poor physical activity 4. Low walking speed 5. Low muscle strength Reference of L.Fried: J Gerontol A Biol Sci Med Sci. 2001 Mar; 56(3):M146-56. PMID: 11253156.
Functional capacity according to Barthel score and Timed up and go test.
Time frame: One year
Barthel score and Timed up and go test.
4 secondary outcomes
Nutritional status according to MNA-sf.
Time frame: One year
Quality of live according to EuroQoL.
Time frame: One year
Mortality
Time frame: One year
Health resource consumption (composite measure)
Time frame: One year
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 2015.
- Derived from this study: PubMed 28064172Serra-Prat M, Sist X, Domenich R, Jurado L, Saiz A, Roces A, Palomera E, Tarradelles M, Papiol M. Effectiveness of an intervention to prevent frailty in pre-frail community-dwelling older people consulting in primary care: a randomised controlled trial. Age Ageing. 2017 May 1;46(3):401-407. doi: 10.1093/ageing/afw242.
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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.
Mateu Serra-Prat, PhD principal investigator
Fundació Salut del Consorci Sanitari del Maresme
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidisciplinary intervention in people with Pre-frail and Elderly, run by Consorci Sanitari del Maresme 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 4 inclusion and 6 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 2015. 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?
Frailty according to L.Fried criteria (questionnaire). (time frame: One year). The study lists 2 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 NCT02138968, 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 1 Sep 2015.