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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
Scientific title
A randomised controlled trial to evaluate the effect of preventive home visits on well being in elderly over 75 years
Secondary ID [1] 282439 0
Nil known
Universal Trial Number (UTN)
U1111-1142-6287
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Well being in the elderly 289908 0
Condition category
Condition code
Public Health 290274 290274 0 0
Health service research

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 287785 0
Prevention
Comparator / control treatment
standard care offered by the city except preventive home visits
Control group
Active

Outcomes
Primary outcome [1] 290299 0
D15 Well being scale change
Timepoint [1] 290299 0
2 years
Secondary outcome [1] 304275 0
How much costs in Euros change in D15 (well being scale)
Timepoint [1] 304275 0
2 years

Eligibility
Key inclusion criteria
Elderly over 75 years without regular home or institutional care
Minimum age
75 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Home or institutional care
age under 75 years

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Spesific computer system randomised the subjects
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
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%.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/08/2013
Date of last participant enrolment
Anticipated
Actual
30/11/2013
Date of last data collection
Anticipated
Actual
31/05/2016
Sample size
Target
392
Accrual to date
Final
422
Recruitment outside Australia
Country [1] 5331 0
Finland
State/province [1] 5331 0

Funding & Sponsors
Funding source category [1] 287832 0
Hospital
Name [1] 287832 0
Helsinki University Hospital
Country [1] 287832 0
Finland
Primary sponsor type
Individual
Name
Pirjo Laitinen-Parkkonen
Address
Hyvinkaa City Health Center
Suutarinkatu 2 C
05801 Hyvinkaa
Finland
Country
Finland
Secondary sponsor category [1] 286565 0
Individual
Name [1] 286565 0
Pekka Lampela
Address [1] 286565 0
Hyvinkaa City Health Center
Suutarinkatu 2 C
05801 Hyvinkaa
Fi land
Country [1] 286565 0
Finland
Other collaborator category [1] 277584 0
Individual
Name [1] 277584 0
Maarit Dimitrow
Address [1] 277584 0
University of Helsinki
Box 33
00014 University of Helsinki
Country [1] 277584 0
Finland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289802 0
Helsinki University Hospital Ethics Committee
Ethics committee address [1] 289802 0
Ethics committee country [1] 289802 0
Finland
Date submitted for ethics approval [1] 289802 0
Approval date [1] 289802 0
19/06/2012
Ethics approval number [1] 289802 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39762 0
Dr Pekka Lampela
Address 39762 0
Hyvinkaa City Health Center
Suutarinkatu 2 C
05801 Hyvinkaa
Finland
Country 39762 0
Finland
Phone 39762 0
+358407540828
Fax 39762 0
Email 39762 0
pekka.lampela@hyvinkaa.fi
Contact person for public queries
Name 39763 0
Pekka Lampela
Address 39763 0
Hyvinkaa City Health Center
Suutarinkatu 2 C
05801 Hyvinkaa
Finland
Country 39763 0
Finland
Phone 39763 0
+358407540828
Fax 39763 0
Email 39763 0
pekka.lampela@hyvinkaa.fi
Contact person for scientific queries
Name 39764 0
Pekka Lampela
Address 39764 0
Hyvinkaa City Health Center
Suutarinkatu 2 C
05801 Hyvinkaa
Finland
Country 39764 0
Finland
Phone 39764 0
+358407540828
Fax 39764 0
Email 39764 0
pekka.lampela@hyvinkaa.fi

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
SourceTitleYear of PublicationDOI
EmbasePreventive home visits to promote the health-related quality of life of home-dwelling older people: Baseline findings and feasibility of a randomized, controlled trial.2017https://dx.doi.org/10.1016/j.eurger.2017.06.003
EmbaseThe Effects of Preventive Home Visits on Older People's Use of Health Care and Social Services and Related Costs.2020https://dx.doi.org/10.1093/gerona/glz139
N.B. These documents automatically identified may not have been verified by the study sponsor.