Clinical and Economic Assessment of a Pre-frail Screening Program
2 other identifiers
interventional
170
1 country
1
Brief Summary
The study intervention improves functional capacity and delays frailty status in pre-frail elderly subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 12, 2014
CompletedFirst Posted
Study publicly available on registry
May 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedSeptember 1, 2015
August 1, 2015
1.9 years
May 12, 2014
August 31, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
One year
Functional capacity according to Barthel score and Timed up and go test.
Barthel score and Timed up and go test.
One year
Secondary Outcomes (4)
Nutritional status according to MNA-sf.
One year
Quality of live according to EuroQoL.
One year
Mortality
One year
Health resource consumption (composite measure)
One year
Other Outcomes (1)
Pain according Visual Analog Scale.
One year
Study Arms (2)
Multidimensional intervention
EXPERIMENTALMultidimensional 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 INTERVENTIONUsual care
Interventions
Multidimensional intervention based on: good control of baseline diseases, review of medication adequacy, exercise program, nutritional assessment and control, social assessment and control.
Eligibility Criteria
You may qualify if:
- More than 70 years consulting in primary care
- Non institutionalized
- Pre-frailty according to L.Fried criteria (1 or 2 criteria)
- Signed informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Consorci Sanitari del Maresme
Mataró, Barcelona, 08304, Spain
Related Publications (1)
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.
PMID: 28064172DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mateu Serra-Prat, PhD
Fundació Salut del Consorci Sanitari del Maresme
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2014
First Posted
May 15, 2014
Study Start
September 1, 2013
Primary Completion
August 1, 2015
Last Updated
September 1, 2015
Record last verified: 2015-08