SUPPORT FOR FRAIL ELDERLY PERSONS - From Prevention to Palliation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Synneve Dahlin Ivanoff, Göteborg University
ClinicalTrials.gov Identifier:
NCT00877058
First received: April 6, 2009
Last updated: June 11, 2014
Last verified: June 2014
  Purpose

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?

Condition Intervention
Frail Elderly Persons
Behavioral: preventive home visit
Behavioral: senior meetings

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Vardalinstitutet The Swedish Institute for Health Sciences:

Primary Outcome Measures:
  • Dependence in Two or More Activities of Daily Living (ADL) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    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


  • Number of Partipants Measured Frail at 1-year Follow up [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Frailty defined as a sum of weakness, fatigue, weight loss, low physical activity, poor balance, slow gait speed, visual impairment and impaired cognition

  • Self Rated Health [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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


Enrollment: 459
Study Start Date: January 2008
Study Completion Date: May 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   80 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00877058

Locations
Sweden
Gothenburg University
Göteborg, Sweden, 416 56
Sponsors and Collaborators
Vardalinstitutet The Swedish Institute for Health Sciences
Investigators
Principal Investigator: Synneve Dahlin Ivanoff, Professor Göteborg University
  More Information

No publications provided by Vardalinstitutet The Swedish Institute for Health Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Synneve Dahlin Ivanoff, Professor, Göteborg University
ClinicalTrials.gov Identifier: NCT00877058     History of Changes
Other Study ID Numbers: G213 194/08
Study First Received: April 6, 2009
Results First Received: October 30, 2013
Last Updated: June 11, 2014
Health Authority: Sweden: Swedish National Council on Medical Ethics

Keywords provided by Vardalinstitutet The Swedish Institute for Health Sciences:
Frailty
health promotion
prevention
self management
intervention

ClinicalTrials.gov processed this record on July 31, 2014