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SUPPORT FOR FRAIL ELDERLY PERSONS - From Prevention to Palliation

Elderly Persons at the Risk Zone - a Randomized Controlled Trial of a Community Based Preventive Multiprofessional Program for Old Persons at Risk of Frailty

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00877058
Enrollment
459
Registered
2009-04-07
Start date
2008-01-31
Completion date
2011-05-31
Last updated
2014-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frail Elderly Persons

Keywords

Frailty, health promotion, prevention, self management, intervention

Brief summary

The present study Elderly person in the risk zone form part of the research programme Support for frail elderly persons - from prevention to palliation (www. Vardalinstitutet.net) which comprises research into three interventions. A fundamental principle in the research programme is that it comprises interventions addressing frail elderly person in different phases of the disablement process, from elderly persons who are beginning to develop frailty to very frail elderly persons receiving palliative care in the final period of their lives. The interventions also address the different requirements that arise with regard to professional contributions during the various phases of the ageing and disease process, ranging from health promotion to a need for an increasing degree of medical care, nursing, special care and rehabilitation, and finally, efforts that promote symptom relief, quality of life, security and satisfaction with care during the final period of life. The intervention Elderly persons in the risk zone addresses elderly persons that are on the point of developing frailty (pre-frail) and are beginning to feel that they are being hindered from taking part in everyday activities. The hypothesis is that if an intervention is made when the persons are not so frail, it is possible to prevent/delay deterioration. 1. Can a health-promoting and preventive intervention for prefrail elderly persons: * prevent frailty, activity limitations and morbidity, * be a supportive factor in the social and physical environment, * affect life satisfaction * have an impact on the consumption of care * be cost-effective? 2. How do the frail elderly persons experience the intervention and its importance to health?

Interventions

Sponsors

Vardalinstitutet The Swedish Institute for Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
80 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 80 years of age or older living in the community. * The participants should live in their ordinary housing * Independent on formal support * Independent on informal support * Cognitive intact defined as a Mini Mental Test score \> 25

Design outcomes

Primary

MeasureTime frameDescription
Dependence in Two or More Activities of Daily Living (ADL)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
Number of Partipants Measured Frail at 1-year Follow up1 yearFrailty defined as a sum of weakness, fatigue, weight loss, low physical activity, poor balance, slow gait speed, visual impairment and impaired cognition
Self Rated Health1 yearSelf 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

Countries

Sweden

Participant flow

Participants by arm

ArmCount
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.
174
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 (table 1). http://www.vardalinstitutet.net/livslots.pdf.
171
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.
114
Total459

Baseline characteristics

Characteristic2 Senior Meetings3 Control Group1 Preventive Home VisitsTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
171 Participants114 Participants174 Participants459 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants0 Participants
Age, Continuous
≥80 years
85 years86 years86 years86 years
Region of Enrollment
Sweden
171 participants114 participants174 participants459 participants
Sex: Female, Male
Female
113 Participants70 Participants111 Participants294 Participants
Sex: Female, Male
Male
58 Participants44 Participants63 Participants165 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
0 / 1740 / 1710 / 114
serious
Total, serious adverse events
0 / 1740 / 1710 / 114

Outcome results

Primary

Dependence in Two or More Activities of Daily Living (ADL)

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

Time frame: 1 year

ArmMeasureValue (NUMBER)
1 Preventive Home VisitsDependence in Two or More Activities of Daily Living (ADL)35 participants
2 Senior MeetingsDependence in Two or More Activities of Daily Living (ADL)26 participants
3 Control GroupDependence in Two or More Activities of Daily Living (ADL)44 participants
p-value: <0.0595% CI: [0.15, 0.48]Chi-squared
p-value: 0.0010.05% CI: [0.24, 0.68]Chi-squared
Primary

Number of Partipants Measured Frail at 1-year 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

Time frame: 1 year

Population: 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.

ArmMeasureValue (NUMBER)
1 Preventive Home VisitsNumber of Partipants Measured Frail at 1-year Follow up80 participants
2 Senior MeetingsNumber of Partipants Measured Frail at 1-year Follow up85 participants
3 Control GroupNumber of Partipants Measured Frail at 1-year Follow up43 participants
p-value: <0.0595% CI: [0.96, 2.52]Chi-squared
p-value: <0.0595% CI: [0.79, 2.08]Chi-squared
Primary

Self Rated Health

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

Time frame: 1 year

Population: ITT

ArmMeasureValue (NUMBER)
1 Preventive Home VisitsSelf Rated Health31 participants
2 Senior MeetingsSelf Rated Health29 participants
3 Control GroupSelf Rated Health31 participants
p-value: <0.0595% CI: [0.31, 0.97]Chi-squared
p-value: <0.0595% CI: [0.33, 1.02]Chi-squared

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026