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Clinical and Economic Assessment of a Pre-frail Screening Program

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ClinicalTrials.gov Identifier: NCT02138968
Recruitment Status : Completed
First Posted : May 15, 2014
Last Update Posted : September 1, 2015
Sponsor:
Information provided by (Responsible Party):
Consorci Sanitari del Maresme

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

Condition or disease Intervention/treatment Phase
Pre-frail Elderly Other: Multidisciplinary intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Clinical and Economic Assessment of an Opportunistic Screening Program for Pre-frailty State in Elderly Population.
Study Start Date : September 2013
Actual Primary Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

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

No Intervention: Usual care
Usual care



Primary Outcome Measures :
  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)

    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.

  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 Outcome Measures :
  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 Outcome Measures:
  1. Pain according Visual Analog Scale. [ Time Frame: One year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138968


Locations
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Spain
Consorci Sanitari del Maresme
Mataró, Barcelona, Spain, 08304
Sponsors and Collaborators
Consorci Sanitari del Maresme
Investigators
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Principal Investigator: Mateu Serra-Prat, PhD Fundació Salut del Consorci Sanitari del Maresme
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Consorci Sanitari del Maresme
ClinicalTrials.gov Identifier: NCT02138968    
Other Study ID Numbers: 17/13
CEIC 17/13 ( Other Identifier: CEIC )
First Posted: May 15, 2014    Key Record Dates
Last Update Posted: September 1, 2015
Last Verified: August 2015
Keywords provided by Consorci Sanitari del Maresme:
Pre-frailty
Frail
Exercise
Nutritional assessment
Functional capacity