ANZCTR - Registration

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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]

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

Condition category

Condition code

Mental Health

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]

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]

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]

At 0, 3 and 6 months

Primary outcome [2]

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]

At baseline and 12 months

Secondary outcome [1]

Mortality

Timepoint [1]

At 3.5 years after the trial started.

Secondary outcome [2]

Subjective health

Timepoint [2]

At 12 months.

Secondary outcome [3]

Cognition: Alzheimer’s Disease Assessment Scale–cognitive subscale (ADAS-Cog).

Timepoint [3]

At baseline, 3 and 6 months.

Secondary outcome [4]

Use of health and social services

Timepoint [4]

At 1 year.

Secondary outcome [5]

Depression: Montgomerry-Åsberg depression scale

Timepoint [5]

At baseline, 3 and 6 months.

Secondary outcome [6]

Number of new friends and proportion of groups continuing their meeting after the intervention is over

Timepoint [6]

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?

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]

Government body

Name [1]

The Finnish Slot Machine Association

Address [1]

Country [1]

Finland

Primary sponsor type

Individual

Name

Kaisu Pitkälä

Address

Country

Secondary sponsor category [1]

Government body

Name [1]

The Central Union for the Welfare fo the Aged, Pirkko Routasalo, Reijo Tilvis

Address [1]

Country [1]

Finland

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Helsinki University hospital Ethics committee-The Central Union for the Welfare of the Aged

Ethics committee address [1]

Ethics committee country [1]

Finland

Date submitted for ethics approval [1]

Approval date [1]

01/09/2002

Ethics approval number [1]

217/E1/2002

Summary

Brief summary

Prior studies indicate athat loneliness causes poor quality of life, impaired cognition, and disability, and increases mortality among older individuals. This study aims to determine the effects of new psychosocial group rehabilitation on the psychological well-being, cognition, subjective health, use of health services, and mortality of lonely older individuals. Social activity, depression, number of new friendships will also be investigated.
Design: A randomized, controlled trial. 
Setting: Six communities and seven rehabilitation centres providing day care.
Participants: 235 older people (>74 years) suffering from loneliness. 
Intervention:  15 groups comprising 7 to 8 participants and 2 professional group leaders meet once a week for 3 months 12 times in total. Group intervention aims to empower elderly people, and to promote their social integration and is based on the effects of closed group dynamics. The individuals are divided according to their interests into groups with following activities: 1) Therapeutic writing and group psychotherapy, 2) Group exercise and discussions, and 3) Art and inspiring activities. Group leaders receive thorough training and mentoring.   
Outcome measures: A psychological well-being score, cognition by ADAS-Cog, subjective health, depression by MADR-scale.Porportion of groups continuing their meeting after one year the official intervention is over, nuber of new friends at one year from baseline, and the use and costs of health services (at one year) and mortality (until 31.12.2005).

Trial website

Trial related presentations / publications

Pitkala KH, Blomqvist L, Routasalo R, Karvinen E, Oikarinen U, Saarenheimo M, Mantyranta 
T. Leading groups of older people: Description and evaluation of education of 
professionals. Educ Gerontol 2004;30:821-34.
Routasalo P, Pitkälä K. Loneliness among older individuals. Clin Rev Gerontol 2004;13;303-
311.
Blomqvist L, Pitkala K, Routasalo P. Images of loneliness. Using art as an educational method 	in professional training. J Continuing Educ Nurs 2007 Mar-Apr;38(2):89-93.
Savikko N, Routasalo P, Tilvis RS; Pitkala KH. Loneliness among older people. Arch Gerontol
Geriatr 2005;41:223-33.
Savikko N, Routasalo P, Tilvis RS, Pitkala KH. Parental loss in childhood and its relationship
with depression, loneliness and life attitudes in old age. J Gerontol Nurs 2006;1:17-24. 
Routasalo P, Tilvis RS, Kautiainen H, Pitkala KH. Effects of psychosocial group rehabilitation on social functioning, loneliness and psychological well-being of lonely older people. A randomized, controlled trial. J Adv Nurs. 2009;65:297-305.
Pitkala KH, Routasalo P, Kautiainen H, Tilvis RS. Effectiveness of psychosocial group 
rehabilitation on mortality and use of health services. J Gerontol 2009;64:792-800
Routasalo P, Savikko N, Tilvis RS, Strandberg TE, Pitkala KH,. Social contacts and loneliness
among aged individuals. A Population-based survey. Gerontology 2006;52:181-7.
Savikko N; Routasalo P, Tilvis S, Pitkälä K. Psychosocial group rehabilitation for lonely older 
people: a description of intervention and participants’ feedback. Int J Older People’s Nurs 2010;5:16-24.
Pitkala KH, Routasalo P, Kautiainen H, Tilvis RS. Effects of socially stimulating group 
intervention on lonely older people’s cogntion – a randomized controlled trial. Am J 
Geriatr Psychiatr 2011;19:654-663.	
Pitkala KH, Routasalo P, Savikko N. Group dynamics in older people’s closed groups. 
Findings from Finnish psychosocial group rehabilitation for lonely older people. 
In : Group Therapy. Nova Publishers 2014.

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Anu Mäkinen

Address

The Central Union for the Welfare of the Aged
Malmin kauppatie 26
00700 Helsinki

Country

Finland

Phone

+358-50-4022529

Fax

ystavapiiri@vanhustyonkeskusliitto.fi

Contact person for scientific queries

Name

Kaisu Pitkälä

Address

Department of General Practice
University of Helsinki
Mannerheimintie 172
FIN-00290 Helsinki
PO Box 41
00014 University of Helsinki

Country

Finland

Phone

+358-50-3385546

Fax

+358-9-19127536

kaisu.pitkala@helsinki.fi

No information has been provided regarding IPD availability

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No Supporting Document Provided

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