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SUPPORT FOR FRAIL ELDERLY PERSONS - From Prevention to Palliation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00877058
Recruitment Status : Completed
First Posted : April 7, 2009
Results First Posted : July 15, 2014
Last Update Posted : July 15, 2014
Information provided by (Responsible Party):
Synneve Dahlin Ivanoff, Göteborg University

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. 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?

Condition or disease Intervention/treatment Phase
Frail Elderly Persons Behavioral: preventive home visit Behavioral: senior meetings Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 459 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Elderly Persons at the Risk Zone - a Randomized Controlled Trial of a Community Based Preventive Multiprofessional Program for Old Persons at Risk of Frailty
Study Start Date : January 2008
Actual Primary Completion Date : February 2011
Actual Study Completion Date : May 2011

Arm Intervention/treatment
Experimental: 1.Preventive home visit
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.
Behavioral: preventive home visit
Experimental: 2. Senior meetings
The 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.
Behavioral: senior meetings
No Intervention: 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.

Primary Outcome Measures :
  1. Dependence in Two or More Activities of Daily Living (ADL) [ Time Frame: 1 year ]

    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

  2. Number of Partipants Measured Frail at 1-year Follow up [ Time Frame: 1 year ]
    Frailty defined as a sum of weakness, fatigue, weight loss, low physical activity, poor balance, slow gait speed, visual impairment and impaired cognition

  3. Self Rated Health [ Time Frame: 1 year ]
    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

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Ages Eligible for Study:   80 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00877058

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Gothenburg University
Göteborg, Sweden, 416 56
Sponsors and Collaborators
Vardalinstitutet The Swedish Institute for Health Sciences
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Principal Investigator: Synneve Dahlin Ivanoff, Professor Göteborg University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Synneve Dahlin Ivanoff, Professor, Göteborg University Identifier: NCT00877058    
Other Study ID Numbers: G213 194/08
First Posted: April 7, 2009    Key Record Dates
Results First Posted: July 15, 2014
Last Update Posted: July 15, 2014
Last Verified: June 2014
Keywords provided by Synneve Dahlin Ivanoff, Göteborg University:
health promotion
self management