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OpenTrials
Completed

NCT Number: NCT02138968

Clinical and Economic Assessment of a Pre-frail Screening Program

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

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Key information

Conditions

Pre-frail Behavior Elderly Motor Activity

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Consorci Sanitari del Maresme

Mataró, Barcelona, 08304, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Multidisciplinary intervention

Other

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

Primary outcomes

  1. 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)

    • 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.

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

    Time frame: One year

    Barthel score and Timed up and go test.

Secondary outcomes

  1. Nutritional status according to MNA-sf.

    Time frame: One year

    Mini Nutritional Assessment short form (MNA-sf).

  2. Quality of live according to EuroQoL.

    Time frame: One year

    EuroQoL.

  3. Mortality

    Time frame: One year

  4. Health resource consumption (composite measure)

    Time frame: One year

    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.

Other outcomes

  1. Pain according Visual Analog Scale.

    Time frame: One year

Sponsors and collaborators

Lead sponsor

Consorci Sanitari del Maresme

Other

Registry information

Official study title

Clinical and Economic Assessment of an Opportunistic Screening Program for Pre-frailty State in Elderly Population.

Important dates

Study start
2013
Primary completion
2015
First posted
May 15, 2014
Registry last updated
Sep 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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