Trial Outcomes & Findings for Education for Prevention and Treatment of Frailty (NCT NCT05610605)
NCT ID: NCT05610605
Last Updated: 2025-12-02
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
235 participants
Primary outcome timeframe
Preintervention/Postintervention (0 and 6 months)
Results posted on
2025-12-02
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
6-month Assessment
STARTED
|
117
|
118
|
|
6-month Assessment
COMPLETED
|
95
|
115
|
|
6-month Assessment
NOT COMPLETED
|
22
|
3
|
|
12-month Assessment
STARTED
|
95
|
115
|
|
12-month Assessment
COMPLETED
|
90
|
109
|
|
12-month Assessment
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
6-month Assessment
Death
|
1
|
1
|
|
6-month Assessment
Lost to Follow-up
|
20
|
0
|
|
6-month Assessment
Institutionalized
|
1
|
2
|
|
12-month Assessment
Death
|
2
|
1
|
|
12-month Assessment
Lost to Follow-up
|
1
|
4
|
|
12-month Assessment
Institutionalized
|
2
|
1
|
Baseline Characteristics
Education for Prevention and Treatment of Frailty
Baseline characteristics by cohort
| Measure |
Control Group
n=117 Participants
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.
|
Intervention Group
n=118 Participants
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.
|
Total
n=235 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
75.6 years
STANDARD_DEVIATION 6.4 • n=121 Participants
|
73.2 years
STANDARD_DEVIATION 6.0 • n=122 Participants
|
74.4 years
STANDARD_DEVIATION 6.3 • n=243 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=121 Participants
|
95 Participants
n=122 Participants
|
159 Participants
n=243 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=121 Participants
|
23 Participants
n=122 Participants
|
76 Participants
n=243 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
|
Race (NIH/OMB)
More than one race
|
117 Participants
n=121 Participants
|
118 Participants
n=122 Participants
|
235 Participants
n=243 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
|
Region of Enrollment
Spain
|
117 Participants
n=121 Participants
|
118 Participants
n=122 Participants
|
235 Participants
n=243 Participants
|
|
Fried's Frailty Criteria
|
2.0 scores on a scale
STANDARD_DEVIATION 0.9 • n=121 Participants
|
2.1 scores on a scale
STANDARD_DEVIATION 1.0 • n=122 Participants
|
2.1 scores on a scale
STANDARD_DEVIATION 1.0 • n=243 Participants
|
PRIMARY outcome
Timeframe: Preintervention/Postintervention (0 and 6 months)Population: Older adults (\>65 years) with frailty phenotype
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
Outcome measures
| Measure |
Control Group
n=95 Participants
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.
|
Intervention Group
n=115 Participants
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.
|
|---|---|---|
|
Evaluation of the Change of Baseline Fried Frailty Criteria at 6 Months
|
2.3 scores on a scale
Standard Deviation 1.1
|
1.4 scores on a scale
Standard Deviation 0.9
|
PRIMARY outcome
Timeframe: Preintervention/Retest (0 and 12 months)Population: Older adults (\>65 years) with frailty phenotype.
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
Outcome measures
| Measure |
Control Group
n=90 Participants
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.
|
Intervention Group
n=109 Participants
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.
|
|---|---|---|
|
Evaluation of the Change of Baseline Fried Frailty Criteria at 12 Months
|
2.5 scores on a scale
Standard Deviation 1.2
|
1.4 scores on a scale
Standard Deviation 1.0
|
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place