Clinical trial NCT01969526: Effectiveness of a Multifactorial Intervention on Frailty
Official title: Effectiveness of a Multifactorial Intervention to Modify Frailty Parameters in Elderly Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frail Elderly
Cognitive Impairment
Dependence
Keywords: Frail elderly
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: Carlos III Health Institute
First posted: 2013-10-25
Enrollment: 352
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Objective: To evaluate the effectiveness of a multifactorial intervention program based on physical activity and diet, memory workshops and review of medication, to modify frailty parameters, muscle strength and physical and cognitive performance in people 65 years or older with a positive screening for frailty. Secondly, to assess changes in falls, hospitalizations, nutritional risk, disability and institutionalization or home-care.

Methods: randomized clinical trial with a control group, of one year and a half of follow-up, conducted in eight primary care teams in Barcelona. Individuals to be included are 65 years or older with positive frailty screening, timed get-up-and-go between 10 to 30 seconds, and cognitive Lobo test greater than or equal to 18. 165 patients will be selected in each group (difference to be detected on physical performance (Short physical performance battery (SPPB)): 0.5 units; common Standard Deviation : 1.42, 20% lost to follow-up).

Intervention: consists in three different actions on frailty dimensions, applied to each subject in the intervention group, in groups of 15 participants: rehabilitative therapy plus intake of hyperproteic shakes, memory workshop and review of the medication.

Evaluations will be blinded and conducted at 0, 3 and 18 months. Analysis of variance for repeated measures to adjust for differences attributable to intervention effect and for potential confounders such as comorbidity, sensory limitations, social risk, other medical or social interventions, among others.


Eligibility criteria: Inclusion Criteria:

* Positive Barber screen
* Timed get-up-and-go 10 to 20 seconds
* cognitive Lobo test greater than or equal to 18

Exclusion Criteria:

* Home Care
* Institutionalization
* Conditions not allowing physical exercise

Primary outcomes:
measure: Change from Baseline in Short Physical performance battery at 3 and 18 months
timeFrame: 0,3,18 months
measure: Change from Baseline in Muscle strength at 3 and 18 months
timeFrame: 0,3,18 months
measure: Change from Baseline in Cognitive Performance (Barcelona test) at 3 and 18 months
timeFrame: 0,3,18 months
Secondary outcomes:
measure: Number of Participants with Falls during follow-up, at 18 months
timeFrame: 18 months
measure: Change from Baseline in Functional Capacity at 18 months
timeFrame: 18 months
measure: Number of Participants Hospitalized during follow-up, at 18 months
timeFrame: 18 months
measure: Number of Participants Institutionalized during follow-up, at 18 months
timeFrame: 18 months
measure: Number of Participants included in Home Health care during follow-up, at 18 months
timeFrame: 18 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Institut Català de la Salut
Study officials:
affiliation: Jordi Gol Foundation
name: Josep Maria segura, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Romera L, Orfila F, Segura JM, Ramirez A, Moller M, Fabra ML, Lancho S, Bastida N, Foz G, Fabregat MA, Marti N, Cullell M, Martinez D, Gine M, Bistuer A, Cendros P, Perez E. Effectiveness of a primary care based multifactorial intervention to improve frailty parameters in the elderly: a randomised clinical trial: rationale and study design. BMC Geriatr. 2014 Nov 27;14:125. doi: 10.1186/1471-2318-14-125.