NCT00877058

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.

  • 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?
  • How do the frail elderly persons experience the intervention and its importance to health?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
459

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 7, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

July 15, 2014

Completed
Last Updated

July 15, 2014

Status Verified

June 1, 2014

Enrollment Period

3.1 years

First QC Date

April 6, 2009

Results QC Date

October 30, 2013

Last Update Submit

June 11, 2014

Conditions

Keywords

Frailtyhealth promotionpreventionself managementintervention

Outcome Measures

Primary Outcomes (3)

  • 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

    1 year

  • 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

    1 year

  • 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

    1 year

Study Arms (3)

1.Preventive home visit

EXPERIMENTAL

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

2. Senior meetings

EXPERIMENTAL

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

3. Control group

NO INTERVENTION

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.

Interventions

1.Preventive home visit
senior meetingsBEHAVIORAL
2. Senior meetings

Eligibility Criteria

Age80 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gothenburg University

Gothenburg, 416 56, Sweden

Location

Related Publications (3)

  • Drahota A, Udell JE, Mackenzie H, Pugh MT. Psychological and educational interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2024 Oct 3;10(10):CD013480. doi: 10.1002/14651858.CD013480.pub2.

  • Dahlin-Ivanoff S, Eklund K, Wilhelmson K, Behm L, Haggblom-Kronlof G, Ziden L, Landahl S, Gustafsson S. For whom is a health-promoting intervention effective? Predictive factors for performing activities of daily living independently. BMC Geriatr. 2016 Oct 6;16(1):171. doi: 10.1186/s12877-016-0345-8.

  • Dahlin-Ivanoff S, Gosman-Hedstrom G, Edberg AK, Wilhelmson K, Eklund K, Duner A, Ziden L, Welmer AK, Landahl S. Elderly persons in the risk zone. Design of a multidimensional, health-promoting, randomised three-armed controlled trial for "prefrail" people of 80+ years living at home. BMC Geriatr. 2010 May 26;10:27. doi: 10.1186/1471-2318-10-27.

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Professor Synneve Dahlin-Ivanoff (Research leader)
Organization
Göteborg University

Study Officials

  • Synneve Dahlin Ivanoff, Professor

    Göteborg University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 6, 2009

First Posted

April 7, 2009

Study Start

January 1, 2008

Primary Completion

February 1, 2011

Study Completion

May 1, 2011

Last Updated

July 15, 2014

Results First Posted

July 15, 2014

Record last verified: 2014-06

Locations