Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000281493
Ethics application status
Approved
Date submitted
18/05/2007
Date registered
28/05/2007
Date last updated
8/10/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Psychosocial group rehabilitation for lonely older people
Scientific title
Effectiveness of psychosocial group rehabilitation for lonely older people on well-being, social activity, cognition, health, mortality and use of health services
Secondary ID [1] 296281 0
NIl
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lonliness and its harmful consequences in older people 1821 0
Condition category
Condition code
Mental Health 1912 1912 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group rehabilitation in a day center (12 times once a week, 5-6 hours/day for 3 months) using group dynamics, peer support, enhancing empowerment and active agency of older people, supporting their social activation.
Intervention code [1] 1770 0
Prevention
Comparator / control treatment
Control group: No intervention/ usual care: they get usual care from social and health care services when they needed it.
Control group
Active

Outcomes
Primary outcome [1] 2724 0
Psychological well-being measured by mean UCLA Loneliness scale.
During the study we found that it was impossible for many of the elderly participants to understand the negative statements in the scale. The whole UCLA scale showed no changes throughout the study.
Timepoint [1] 2724 0
At 0, 3 and 6 months
Primary outcome [2] 2725 0
Mean Psychological well-being score
Psychological well-being score includes questions on loneliness, depression, feeling needed, satisfaction with life, having zest for life, having plans for the future.
Timepoint [2] 2725 0
At baseline and 12 months
Secondary outcome [1] 4588 0
Mortality
Timepoint [1] 4588 0
At 3.5 years after the trial started.
Secondary outcome [2] 4589 0
Subjective health
Timepoint [2] 4589 0
At 12 months.
Secondary outcome [3] 4590 0
Cognition: Alzheimer’s Disease Assessment Scale–cognitive subscale (ADAS-Cog).
Timepoint [3] 4590 0
At baseline, 3 and 6 months.
Secondary outcome [4] 4591 0
Use of health and social services
Timepoint [4] 4591 0
At 1 year.
Secondary outcome [5] 4592 0
Depression: Montgomerry-Åsberg depression scale
Timepoint [5] 4592 0
At baseline, 3 and 6 months.
Secondary outcome [6] 4593 0
Number of new friends and proportion of groups continuing their meeting after the intervention is over
Timepoint [6] 4593 0
At 1 year .

Eligibility
Key inclusion criteria
Having subjective feelings of loneliness, volunteering to participate in the group intervention and having an interest in the content offered in the rehabilitation group.
Minimum age
75 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Moderate or severe dementia (Mini-Mental State Examination25 (MMSE) < 19 points) or a Clinical Dementia Rating26 (CDR) > 1), living permanently in institutional care, blindness, deafness or the inability to move independently without another person’s aid, New York Heart Association Classification (NYHA) 27 classes 3 and 4 constituted additional exclusion criteria.Both males and females could participate.

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)
Central randomisation by phone and computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomization table was created by a computerised sequence generation. Stratified randomisation was used so that the participants would be allocated to groups having contents according to their interests.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The participants received either no intervention or group rehabilitation intervention, which was tailored according to their interests.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/01/2003
Actual
13/01/2003
Date of last participant enrolment
Anticipated
Actual
31/12/2003
Date of last data collection
Anticipated
Actual
31/12/2007
Sample size
Target
235
Accrual to date
Final
235

Funding & Sponsors
Funding source category [1] 2058 0
Government body
Name [1] 2058 0
The Finnish Slot Machine Association
Country [1] 2058 0
Finland
Primary sponsor type
Individual
Name
Kaisu Pitkälä
Address
Country
Secondary sponsor category [1] 1865 0
Government body
Name [1] 1865 0
The Central Union for the Welfare fo the Aged, Pirkko Routasalo, Reijo Tilvis
Address [1] 1865 0
Country [1] 1865 0
Finland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3823 0
Helsinki University hospital Ethics committee-The Central Union for the Welfare of the Aged
Ethics committee address [1] 3823 0
Ethics committee country [1] 3823 0
Finland
Date submitted for ethics approval [1] 3823 0
Approval date [1] 3823 0
01/09/2002
Ethics approval number [1] 3823 0
217/E1/2002

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

Contacts
Principal investigator
Name 27873 0
Address 27873 0
Country 27873 0
Phone 27873 0
Fax 27873 0
Email 27873 0
Contact person for public queries
Name 10959 0
Anu Mäkinen
Address 10959 0
The Central Union for the Welfare of the Aged
Malmin kauppatie 26
00700 Helsinki
Country 10959 0
Finland
Phone 10959 0
+358-50-4022529
Fax 10959 0
Email 10959 0
[email protected]
Contact person for scientific queries
Name 1887 0
Kaisu Pitkälä
Address 1887 0
Department of General Practice
University of Helsinki
Mannerheimintie 172
FIN-00290 Helsinki
PO Box 41
00014 University of Helsinki
Country 1887 0
Finland
Phone 1887 0
+358-50-3385546
Fax 1887 0
+358-9-19127536
Email 1887 0
[email protected]

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
No additional documents have been identified.