Frail Elderly Syndrome, Frailty
Conditions
Keywords
Elderly Persons, Aging, Cost-Efficiency Analysis, Health Education
Brief summary
Frailty is a condition with a high prevalence in older adults, leading to higher vulnerability and increasing the risk of adverse health outcomes and disabilities. The aging of the population in Spain is accelerating quickly, consequently, it is necessary to advise the population on the appropriate path to healthy aging, free of fragility and their secondary problems.
Detailed description
To evaluate the efficacy and efficiency of a Fragsalud program for the prevention and multifactorial treatment of frailty in people over 65 years of age living in the community compared to the usual treatment. Material and methods: A Single blind randomized, two-arm clinical trial; control group and intervention group, multicenter, with 15 months of follow-up, with evaluations blinded at the beginning, and in the follow-up at 12 and 15 months. A recruitment of 196 people over 65 years of age with criteria of pre-frailty or frailty according to Fried's criteria. The Fragsalud education program will be taught in the intervention group; while control group will follow the usual health care. The evolution of the criteria of frailty, cognitive state, eating pattern, emotional state, quality of sleep, perceived social support, quality of life, functional capacity in daily life, adverse results, assessment of self-efficacy and cost-utility analysis variables will be evaluated. Possible confounding factors such as sociodemographic variables, comorbidity and polymedication will be controlled. Intention-to-treat analysis will be performed.
Interventions
OTHERHealth intervention programme: FRAGSALUD
The FRAGSALUD Program consists in two parts, a first part of health education that will be taught in a group in four sessions, and a second part of individual treatment and follow-up, individual consultations will have a bimonthly periodicity until reaching one year, at which time that the program ends and a final evaluation will be carried out to assess whether the changes are maintained 15 months after the start.
Sponsors
University of Malaga
Instituto de investigación e innovación biomédica de Cádiz
University of Cadiz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients over 65 years of age who present frailty or pre-frailty, assessed using the Fried criteria adapted to Spanish population; * Patients belonging to Clinical Management Units participating in the study and who will remain in it for the 15 months of the study; * Patients who can come to the Health Center alone or accompanied.
Exclusion criteria
* Patients with no full control of their capabilities. * Patients who do not understand Spanish; * Patients with allergies to plastic or metal. * Patients who are instutionalized.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the Change of Baseline Fried Frailty Criteria at 6 Months | Preintervention/Postintervention (0 and 6 months) | Assessment of frailty using the Fried Frailty Phenotype. This is a five-component measure used to classify frailty status (unintentional weight loss, exhaustion, weakness, slow walking speed, and low physical activity). A score of 1 is assigned for each criterion met, yielding a total score that ranges from 0 to 5. A higher score indicates a worse outcome (greater frailty). 0 = Robust (non-frail) 1-2 = Pre-frail 3-5 = Frail |
| Evaluation of the Change of Baseline Fried Frailty Criteria at 12 Months | Preintervention/Retest (0 and 12 months) | Assessment of frailty using the Fried Frailty Phenotype. This is a five-component measure used to classify frailty status (unintentional weight loss, exhaustion, weakness, slow walking speed, and low physical activity). A score of 1 is assigned for each criterion met, yielding a total score that ranges from 0 to 5. A higher score indicates a worse outcome (greater frailty). 0 = Robust (non-frail) 1-2 = Pre-frail 3-5 = Frail |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group Participants who do not receive attention from the Fragsalud program. The control group follows the usual care and preventive measures in Primary Care, according to different protocols implemented and the criteria of nurses and family doctors responsible for their care. | 117 |
| Intervention Group The FRAGSALUD Programme is a multidomain intervention programme, which covers the prevention and treatment of frailty from different aspects, fundamentally from a physical and cognitive aspect and to maintain social integration, although other modifiable factors that are related to the presence of fragility such as hearing impairment, visual deficit or depression.
Health intervention programme: FRAGSALUD: The FRAGSALUD Program consists in two parts, a first part of health education that will be taught in a group in four sessions, and a second part of individual treatment and follow-up, individual consultations will have a bimonthly periodicity until reaching one year, at which time that the program ends and a final evaluation will be carried out to assess whether the changes are maintained 15 months after the start. | 118 |
| Total | 235 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 12-month Assessment | Death | 2 | 1 |
| 12-month Assessment | Institutionalized | 2 | 1 |
| 12-month Assessment | Lost to Follow-up | 1 | 4 |
| 6-month Assessment | Death | 1 | 1 |
| 6-month Assessment | Institutionalized | 1 | 2 |
| 6-month Assessment | Lost to Follow-up | 20 | 0 |
Baseline characteristics
| Characteristic | Control Group | Intervention Group | Total |
|---|---|---|---|
| Age, Continuous | 75.6 years STANDARD_DEVIATION 6.4 | 73.2 years STANDARD_DEVIATION 6 | 74.4 years STANDARD_DEVIATION 6.3 |
| Fried's Frailty Criteria | 2.0 scores on a scale STANDARD_DEVIATION 0.9 | 2.1 scores on a scale STANDARD_DEVIATION 1 | 2.1 scores on a scale STANDARD_DEVIATION 1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 117 Participants | 118 Participants | 235 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Spain | 117 Participants | 118 Participants | 235 Participants |
| Sex: Female, Male Female | 64 Participants | 95 Participants | 159 Participants |
| Sex: Female, Male Male | 53 Participants | 23 Participants | 76 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 117 | 2 / 118 |
| other Total, other adverse events | 0 / 117 | 0 / 118 |
| serious Total, serious adverse events | 0 / 117 | 0 / 118 |
Outcome results
Primary
Evaluation of the Change of Baseline Fried Frailty Criteria at 12 Months
Assessment of frailty using the Fried Frailty Phenotype. This is a five-component measure used to classify frailty status (unintentional weight loss, exhaustion, weakness, slow walking speed, and low physical activity). A score of 1 is assigned for each criterion met, yielding a total score that ranges from 0 to 5. A higher score indicates a worse outcome (greater frailty). 0 = Robust (non-frail) 1-2 = Pre-frail 3-5 = Frail
Time frame: Preintervention/Retest (0 and 12 months)
Population: Older adults (\>65 years) with frailty phenotype.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Evaluation of the Change of Baseline Fried Frailty Criteria at 12 Months | 2.5 scores on a scale | Standard Deviation 1.2 |
| Intervention Group | Evaluation of the Change of Baseline Fried Frailty Criteria at 12 Months | 1.4 scores on a scale | Standard Deviation 1 |
Primary
Evaluation of the Change of Baseline Fried Frailty Criteria at 6 Months
Assessment of frailty using the Fried Frailty Phenotype. This is a five-component measure used to classify frailty status (unintentional weight loss, exhaustion, weakness, slow walking speed, and low physical activity). A score of 1 is assigned for each criterion met, yielding a total score that ranges from 0 to 5. A higher score indicates a worse outcome (greater frailty). 0 = Robust (non-frail) 1-2 = Pre-frail 3-5 = Frail
Time frame: Preintervention/Postintervention (0 and 6 months)
Population: Older adults (\>65 years) with frailty phenotype
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Evaluation of the Change of Baseline Fried Frailty Criteria at 6 Months | 2.3 scores on a scale | Standard Deviation 1.1 |
| Intervention Group | Evaluation of the Change of Baseline Fried Frailty Criteria at 6 Months | 1.4 scores on a scale | Standard Deviation 0.9 |