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CompletedNCT02138968Updated Sep 1, 2015

Clinical and Economic Assessment of a Pre-frail Screening Program

An interventional study of Multidisciplinary intervention in Pre-frail and Elderly, sponsored by Consorci Sanitari del Maresme. Completed at 1 site in Spain. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2015-09-01.

Sponsored by Consorci Sanitari del Maresme · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
170
Allocation
Randomized
Ages
70 Years and older
Sex
All
01

Study summary

The study intervention improves functional capacity and delays frailty status in pre-frail elderly subjects.

02

Conditions studied

  • Pre-frail
  • Elderly

Keywords

  • Pre-frailty
  • Frail
  • Exercise
  • Nutritional assessment
  • Functional capacity
03

In context

Lead sponsor

Consorci Sanitari del Maresme is the lead sponsor of 15 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
70 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • More than 70 years consulting in primary care
  • Non institutionalized
  • Pre-frailty according to L.Fried criteria (1 or 2 criteria)
  • Signed informed consent

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
170 participants (actual)

Study arms

  • Experimental
    Multidimensional intervention

    Multidimensional intervention based on: good control of baseline diseases, review of medication adequacy, exercise program, nutritional assessment and control, social assessment and control.

    Other: Multidisciplinary intervention

  • No intervention
    Usual care

    Usual care

Interventions

  • OtherMultidisciplinary intervention

    Multidimensional intervention based on: good control of baseline diseases, review of medication adequacy, exercise program, nutritional assessment and control, social assessment and control.

06

What researchers measure

Primary outcomes

  1. Frailty according to L.Fried criteria (questionnaire).

    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.

    Time frame: One year

  2. Functional capacity according to Barthel score and Timed up and go test.

    Barthel score and Timed up and go test.

    Time frame: One year

Secondary outcomes

  1. Nutritional status according to MNA-sf.

    Mini Nutritional Assessment short form (MNA-sf).

    Time frame: One year

  2. Quality of live according to EuroQoL.

    EuroQoL.

    Time frame: One year

  3. Mortality

    Time frame: One year

  4. 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.

    Time frame: One year

Other outcomes

  1. Pain according Visual Analog Scale.

    Time frame: One year

07

Study locations

1 site
  • Consorci Sanitari del Maresme
    Mataró, Barcelona 08304, Spain
08

References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02138968
Lead sponsor
Consorci Sanitari del Maresme
Responsible party
Sponsor
First posted
May 15, 2014
Start date
Sep 2013
Primary completion
Aug 2015
Last update
Sep 1, 2015

Study contacts

Mateu Serra-Prat, PhD
principal investigator · Fundació Salut del Consorci Sanitari del Maresme
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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