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Trial registered on ANZCTR
Registration number
ACTRN12616001411437
Ethics application status
Approved
Date submitted
28/08/2013
Date registered
10/10/2016
Date last updated
10/10/2016
Type of registration
Retrospectively registered
Titles & IDs
Public title
Evaluation of preventive home visits in elderly over 75 years
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Scientific title
A randomised controlled trial to evaluate the effect of preventive home visits on well being in elderly over 75 years
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Secondary ID [1]
282439
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Nil known
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Universal Trial Number (UTN)
U1111-1142-6287
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Well being in the elderly
289908
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Condition category
Condition code
Public Health
290274
290274
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0
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Health service research
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
multidiciplinary home visits two years observation. The preventive home visits were delivered by a nurse with experience of working with geriatric patients, a physiotherapist and a social worker. The team of professionals had a possibility to consult a doctor from a geriatric ward if needed. The intervention protocol was planned and discussed together with all the team members, including the doctor, and uniform instructions were given personally and on paper to all of the persons delivering the home visits.
All professionals visited the participants of the intervention group once. The three home visits were delivered during a time period of 6 to 9 months, first the nurse visit, second the physiotherapist visit and the social worker visit last. The interval between each visit to the participant was circa 3 months, but due to practical arrangements (vacations etc.) the interval varied from 1 month to 6 months. Most of the visits were delivered with 3 month intervals.
The nurse home visit lasted 1-1,5 hours per participant. During the home visit the nurse made a structured assessment on functioning, quality of life, nutrition, memory functions, depression, activities of daily living and instrumental activities on daily living.The nurse also measured blood pressure and blood glucose levels of the participant. The participant was given information about the different health and social services offered by the municipality and local voluntary and third sector organizations. If concerns on the health or well-being of the participant arouse from the visit, the nurse directed them to contact their family doctor, the memory clinic or other suitable health or social service and left written contact information of the consequential services.
Physiotherapist home visits were delivered during march 2014 to may 2014. The physiotherapist home visit lasted 1-1,5 hours per participant. During the home visit the physiotherapist made a structured assessment of the barriers of mobility, fall risk and home safety (FROP- Com Screen and home safety assessment). The physiotherapist also performed a hand grip strength test (Jamar) and chair stand test to the participant. Individual excercise instructions were compiled by the physiotherapist based on the test results and the motivation and wishes of the participant, and these compiled written instructions were given to the participant. The participant was given information on the services the municipality physiotherapy offers for individuals and groups, and services offered and groups aranged by local voluntary and third sector organizations. Based on the assessment and the wishes and needs of the participants, the physiotherapist left written contact information of the consequential services and/or arranged prospective physiotherapy services.
The social worker home visit lasted 0,5-1,5 hours per participant and made a structured assessment on social functioning,The social worker also gave information on financial and other benefits for older people and the social services provided by the municipality and local voluntary and third sector organizations, and left contact information when needed.
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Intervention code [1]
287785
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Prevention
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Comparator / control treatment
standard care offered by the city except preventive home visits
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Control group
Active
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Outcomes
Primary outcome [1]
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D15 Well being scale change
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Assessment method [1]
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Timepoint [1]
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2 years
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Secondary outcome [1]
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How much costs in Euros change in D15 (well being scale)
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Assessment method [1]
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Timepoint [1]
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2 years
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Eligibility
Key inclusion criteria
Elderly over 75 years without regular home or institutional care
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Minimum age
75
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Home or institutional care
age under 75 years
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects were randomized to two groups with computer-generated random numbers (Computer program Randomizer). Allocation was concealed.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Spesific computer system randomised the subjects
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
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Type of endpoint/s
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Statistical methods / analysis
Descriptive. We calculated the needed sample size with strength calculation based on change in 15D, the primary outcome of our study. The strength calculation is based on detecting a difference of 0.03 points in 15D. We assume the standard deviation of 15D to be 0.15 for this calculation. The calculated minimum sample size was 392 study participants, when type 1 error is 5% and strength being 80%.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
1/08/2013
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Date of last participant enrolment
Anticipated
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Actual
30/11/2013
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Date of last data collection
Anticipated
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Actual
31/05/2016
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Sample size
Target
392
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Accrual to date
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Final
422
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Recruitment outside Australia
Country [1]
5331
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Finland
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State/province [1]
5331
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Funding & Sponsors
Funding source category [1]
287832
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Hospital
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Name [1]
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Helsinki University Hospital
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Address [1]
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Helsinki University Hospital
Box 100, 00029 HUS
Finland
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Country [1]
287832
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Finland
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Primary sponsor type
Individual
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Name
Pirjo Laitinen-Parkkonen
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Address
Hyvinkaa City Health Center
Suutarinkatu 2 C
05801 Hyvinkaa
Finland
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Country
Finland
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Secondary sponsor category [1]
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Individual
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Name [1]
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Pekka Lampela
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Address [1]
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Hyvinkaa City Health Center
Suutarinkatu 2 C
05801 Hyvinkaa
Fi land
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Country [1]
286565
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Finland
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Other collaborator category [1]
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Individual
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Name [1]
277584
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Maarit Dimitrow
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Address [1]
277584
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University of Helsinki
Box 33
00014 University of Helsinki
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Country [1]
277584
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Finland
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
289802
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Helsinki University Hospital Ethics Committee
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Ethics committee address [1]
289802
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BoX 705
00029 HUS
Finland
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Ethics committee country [1]
289802
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Finland
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Date submitted for ethics approval [1]
289802
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Approval date [1]
289802
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19/06/2012
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Ethics approval number [1]
289802
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Summary
Brief summary
RCT studying the effect of preventative home visits in elderly over 75 not receiving home or institutional care on the well being (measured with D15 method), medication errors and on social and health care usage and cost. The duration of the study is 2 years, followed by additional one-year follow up in the intervetion group.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Pekka Lampela
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Address
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Hyvinkaa City Health Center
Suutarinkatu 2 C
05801 Hyvinkaa
Finland
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Country
39762
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Finland
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Phone
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+358407540828
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Fax
39762
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Email
39762
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[email protected]
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Contact person for public queries
Name
39763
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Dr Pekka Lampela
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Address
39763
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Hyvinkaa City Health Center
Suutarinkatu 2 C
05801 Hyvinkaa
Finland
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Country
39763
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Finland
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Phone
39763
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+358407540828
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Fax
39763
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Email
39763
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[email protected]
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Contact person for scientific queries
Name
39764
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Dr Pekka Lampela
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Address
39764
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Hyvinkaa City Health Center
Suutarinkatu 2 C
05801 Hyvinkaa
Finland
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Country
39764
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Finland
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Phone
39764
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+358407540828
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Fax
39764
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Email
39764
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
The Effects of Preventive Home Visits on Older People's Use of Health Care and Social Services and Related Costs.
2020
https://dx.doi.org/10.1093/gerona/glz139
Embase
Preventive home visits to promote the health-related quality of life of home-dwelling older people: Baseline findings and feasibility of a randomized, controlled trial.
2017
https://dx.doi.org/10.1016/j.eurger.2017.06.003
N.B. These documents automatically identified may not have been verified by the study sponsor.
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