Trial Outcomes & Findings for SUPPORT FOR FRAIL ELDERLY PERSONS - From Prevention to Palliation (NCT NCT00877058)
NCT ID: NCT00877058
Last Updated: 2014-07-15
Results Overview
ADL stair case: Independence of, or dependence on, another person in ADL was assessed according to a cumulative scale of well-defined personal and instrumental activities, the ADL staircase. Nine out of the ten original activities were used; Cleaning, shopping, transportation, cooking, bathing, dressing, going to the toilet, transfer, and feeding (0-9). Dependence was defined as another person being involved in the activity by giving personal or directive assistance. People living together were assessed as independent if they performed the activity when alone. The number of partipants with dependence in two or more ADL at follow-up have been analyzed
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
459 participants
Primary outcome timeframe
1 year
Results posted on
2014-07-15
Participant Flow
Participant milestones
| Measure |
1 Preventive Home Visits
This intervention included a single home visit made by either a nurse, a physiotherapist, a qualified social worker or an occupational therapist. Participants received verbal and written information/advice about what the districts could provide. The preventive home visit was guided by a protocol, which included an opportunity for individuals to further elaborate on certain elements. The visit lasted between one and a half to two hours.
|
2 Senior Meetings
The intervention senior meetings comprised four weekly meetings with about six participants in each group. The main purpose was to focus on two different topics: 1) information about the ageing process and its consequences and 2) provision of tools and strategies for solving problems that can arise in the home environment. A follow-up home visit took place two to three weeks after the group sessions were completed. The group meetings were led either by an occupational therapist, a registered nurse, a physiotherapist or a qualified social worker, all of whom spoke about their particular dimension of aging. They jointly planned and carried out the intervention and were responsible for their specific part of the meetings. T The participants' experiences formed the basis of the meetings. A booklet was especially produced for the meetings, which includes texts that cover different areas of health, discussed at each of the meetings. http://www.vardalinstitutet.net/livslots.pdf.
|
3 Control Group
The control group had access to the ordinary range of services if requested from the urban districts for the aged. The aim of the municipal provision of care for the older persons is to ensure the ability to live as independently as possible. This includes remaining in their homes. When an older person in Sweden has difficulties managing independently, she or he can apply for assistance from the district. The extent of such support is subject to an assessment of needs and includes meals on wheels, help with cleaning and shopping, assistance with personal care, safety alarms and transportation service. The older person are also offered healthcare, provided either by municipal home help or home medical care services.
|
|---|---|---|---|
|
Overall Study
STARTED
|
174
|
171
|
114
|
|
Overall Study
COMPLETED
|
137
|
131
|
75
|
|
Overall Study
NOT COMPLETED
|
37
|
40
|
39
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SUPPORT FOR FRAIL ELDERLY PERSONS - From Prevention to Palliation
Baseline characteristics by cohort
| Measure |
1 Preventive Home Visits
n=174 Participants
This intervention included a single home visit made by either a nurse, a physiotherapist, a qualified social worker or an occupational therapist. Participants received verbal and written information/advice about what the districts could provide. The preventive home visit was guided by a protocol, which included an opportunity for individuals to further elaborate on certain elements. The visit lasted between one and a half to two hours.
|
2 Senior Meetings
n=171 Participants
The intervention senior meetings comprised four weekly meetings with about six participants in each group. The main purpose was to focus on two different topics: 1) information about the ageing process and its consequences and 2) provision of tools and strategies for solving problems that can arise in the home environment. A follow-up home visit took place two to three weeks after the group sessions were completed. The group meetings were led either by an occupational therapist, a registered nurse, a physiotherapist or a qualified social worker, all of whom spoke about their particular dimension of aging. They jointly planned and carried out the intervention and were responsible for their specific part of the meetings. T The participants' experiences formed the basis of the meetings. A booklet was especially produced for the meetings, which includes texts that cover different areas of health, discussed at each of the meetings (table 1). http://www.vardalinstitutet.net/livslots.pdf.
|
3 Control Group
n=114 Participants
The control group had access to the ordinary range of services if requested from the urban districts for the aged. The aim of the municipal provision of care for the older persons is to ensure the ability to live as independently as possible. This includes remaining in their homes. When an older person in Sweden has difficulties managing independently, she or he can apply for assistance from the district. The extent of such support is subject to an assessment of needs and includes meals on wheels, help with cleaning and shopping, assistance with personal care, safety alarms and transportation service. The older person are also offered healthcare, provided either by municipal home help or home medical care services.
|
Total
n=459 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
174 Participants
n=5 Participants
|
171 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
459 Participants
n=4 Participants
|
|
Age, Continuous
≥80 years
|
86 years
n=5 Participants
|
85 years
n=7 Participants
|
86 years
n=5 Participants
|
86 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
111 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
294 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
165 Participants
n=4 Participants
|
|
Region of Enrollment
Sweden
|
174 participants
n=5 Participants
|
171 participants
n=7 Participants
|
114 participants
n=5 Participants
|
459 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 1 yearADL stair case: Independence of, or dependence on, another person in ADL was assessed according to a cumulative scale of well-defined personal and instrumental activities, the ADL staircase. Nine out of the ten original activities were used; Cleaning, shopping, transportation, cooking, bathing, dressing, going to the toilet, transfer, and feeding (0-9). Dependence was defined as another person being involved in the activity by giving personal or directive assistance. People living together were assessed as independent if they performed the activity when alone. The number of partipants with dependence in two or more ADL at follow-up have been analyzed
Outcome measures
| Measure |
1 Preventive Home Visits
n=174 Participants
This intervention included a single home visit made by either a nurse, a physiotherapist, a qualified social worker or an occupational therapist. Participants received verbal and written information/advice about what the districts could provide. The preventive home visit was guided by a protocol, which included an opportunity for individuals to further elaborate on certain elements. The visit lasted between one and a half to two hours.
|
2 Senior Meetings
n=171 Participants
The intervention senior meetings comprised four weekly meetings with about six participants in each group. The main purpose was to focus on two different topics: 1) information about the ageing process and its consequences and 2) provision of tools and strategies for solving problems that can arise in the home environment. A follow-up home visit took place two to three weeks after the group sessions were completed. The group meetings were led either by an occupational therapist, a registered nurse, a physiotherapist or a qualified social worker, all of whom spoke about their particular dimension of aging. They jointly planned and carried out the intervention and were responsible for their specific part of the meetings. T The participants' experiences formed the basis of the meetings. A booklet was especially produced for the meetings, which includes texts that cover different areas of health, discussed at each of the meetings (table 1). http://www.vardalinstitutet.net/livslots.pdf.
|
3 Control Group
n=114 Participants
The control group had access to the ordinary range of services if requested from the urban districts for the aged. The aim of the municipal provision of care for the older persons is to ensure the ability to live as independently as possible. This includes remaining in their homes. When an older person in Sweden has difficulties managing independently, she or he can apply for assistance from the district. The extent of such support is subject to an assessment of needs and includes meals on wheels, help with cleaning and shopping, assistance with personal care, safety alarms and transportation service. The older person are also offered healthcare, provided either by municipal home help or home medical care services.
|
|---|---|---|---|
|
Dependence in Two or More Activities of Daily Living (ADL)
|
35 participants
|
26 participants
|
44 participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: ITT was used. The basic assumption was that older adults (80+) deteriorate over time in the natural course of the aging process. The imputation method chosen was to replace missing values with a value based on the Median Change of Deterioration (MCD) a conservative form of worst case between baseline and follow-up.
Frailty defined as a sum of weakness, fatigue, weight loss, low physical activity, poor balance, slow gait speed, visual impairment and impaired cognition
Outcome measures
| Measure |
1 Preventive Home Visits
n=174 Participants
This intervention included a single home visit made by either a nurse, a physiotherapist, a qualified social worker or an occupational therapist. Participants received verbal and written information/advice about what the districts could provide. The preventive home visit was guided by a protocol, which included an opportunity for individuals to further elaborate on certain elements. The visit lasted between one and a half to two hours.
|
2 Senior Meetings
n=171 Participants
The intervention senior meetings comprised four weekly meetings with about six participants in each group. The main purpose was to focus on two different topics: 1) information about the ageing process and its consequences and 2) provision of tools and strategies for solving problems that can arise in the home environment. A follow-up home visit took place two to three weeks after the group sessions were completed. The group meetings were led either by an occupational therapist, a registered nurse, a physiotherapist or a qualified social worker, all of whom spoke about their particular dimension of aging. They jointly planned and carried out the intervention and were responsible for their specific part of the meetings. T The participants' experiences formed the basis of the meetings. A booklet was especially produced for the meetings, which includes texts that cover different areas of health, discussed at each of the meetings (table 1). http://www.vardalinstitutet.net/livslots.pdf.
|
3 Control Group
n=114 Participants
The control group had access to the ordinary range of services if requested from the urban districts for the aged. The aim of the municipal provision of care for the older persons is to ensure the ability to live as independently as possible. This includes remaining in their homes. When an older person in Sweden has difficulties managing independently, she or he can apply for assistance from the district. The extent of such support is subject to an assessment of needs and includes meals on wheels, help with cleaning and shopping, assistance with personal care, safety alarms and transportation service. The older person are also offered healthcare, provided either by municipal home help or home medical care services.
|
|---|---|---|---|
|
Number of Partipants Measured Frail at 1-year Follow up
|
80 participants
|
85 participants
|
43 participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: ITT
Self rated health was measured by the question "In general would yoy say your health is: excellent, very good, good, fair or poor? Number of participants detoriated in self-rated health has been analysed
Outcome measures
| Measure |
1 Preventive Home Visits
n=174 Participants
This intervention included a single home visit made by either a nurse, a physiotherapist, a qualified social worker or an occupational therapist. Participants received verbal and written information/advice about what the districts could provide. The preventive home visit was guided by a protocol, which included an opportunity for individuals to further elaborate on certain elements. The visit lasted between one and a half to two hours.
|
2 Senior Meetings
n=171 Participants
The intervention senior meetings comprised four weekly meetings with about six participants in each group. The main purpose was to focus on two different topics: 1) information about the ageing process and its consequences and 2) provision of tools and strategies for solving problems that can arise in the home environment. A follow-up home visit took place two to three weeks after the group sessions were completed. The group meetings were led either by an occupational therapist, a registered nurse, a physiotherapist or a qualified social worker, all of whom spoke about their particular dimension of aging. They jointly planned and carried out the intervention and were responsible for their specific part of the meetings. T The participants' experiences formed the basis of the meetings. A booklet was especially produced for the meetings, which includes texts that cover different areas of health, discussed at each of the meetings (table 1). http://www.vardalinstitutet.net/livslots.pdf.
|
3 Control Group
n=114 Participants
The control group had access to the ordinary range of services if requested from the urban districts for the aged. The aim of the municipal provision of care for the older persons is to ensure the ability to live as independently as possible. This includes remaining in their homes. When an older person in Sweden has difficulties managing independently, she or he can apply for assistance from the district. The extent of such support is subject to an assessment of needs and includes meals on wheels, help with cleaning and shopping, assistance with personal care, safety alarms and transportation service. The older person are also offered healthcare, provided either by municipal home help or home medical care services.
|
|---|---|---|---|
|
Self Rated Health
|
31 participants
|
29 participants
|
31 participants
|
Adverse Events
1 Preventive Home Visits
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
2 Senior Meetings
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
3 Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Professor Synneve Dahlin-Ivanoff (Research leader)
Göteborg University
Phone: +46317865733
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place