NCT02047435

Brief Summary

Social relationships are important to people and it affects their quality of life, morbidity and mortality. This is a randomised controlled trial studying the effect of including older people with impaired social relationships and a perception of loneliness at workshops, at The Storm P. Museum - a museum about the well known Danish cartoonist Robert Storm Petersen. The hypothesis is, that by including older lonely people with a impaired social participation in these workshops, they will increase the participants health related quality of life. The investigators also hypothesis, that the intervention will improve the participants perception of loneliness, social participation and physical function. The intervention consist of a series of workshops at the Storm P. Museum. At these workshops the participants will create memory material for nursing home residents with dementia. The museum staff will facilitate a process of storytelling, using events, significant stories and artistic works by Storm P. and encourage the participants, by means of the "narrative interview" method to share similar stories from their life.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable quality-of-life

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 28, 2014

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Last Updated

May 23, 2014

Status Verified

January 1, 2014

Enrollment Period

1.5 years

First QC Date

January 24, 2014

Last Update Submit

May 22, 2014

Conditions

Keywords

Social participationLonelinessGeneral practiceCultural institutions

Outcome Measures

Primary Outcomes (1)

  • Difference from baseline in summary Index of EuroQol -5D

    Health related quality of life measured by EuroQol -5D

    Baseline, 9 months and 18 months

Secondary Outcomes (7)

  • Score of MMSE test

    Baseline, 9 months, 18 months

  • Score of GDS-15 items

    baseline, 9 months and 18 months

  • "Timed up and go" test

    Baseline, 9 months and 18 months

  • Consultation at general practice and hospital admission

    Baseline, 9 months and 18 months

  • Score on Mobility-Tiredness scale

    Baseline, 9 months and 18 months

  • +2 more secondary outcomes

Other Outcomes (3)

  • All cause mortality

    36 month

  • Permanent nursing home placement

    36 month

  • Health economic analysis

    36 month

Study Arms (2)

Information, event and workshops at a cartoon museum

EXPERIMENTAL
Behavioral: Information, event and workshops at a cartoon museum

Information and event at a cartoon museum

ACTIVE COMPARATOR
Behavioral: Information and event at a cartoon museum

Interventions

1. An event at the Storm P. Museum consisting of: * A guided tour at the museum * A representative from the municipal DaneAge Association will tell about the municipality's activities for the elderly. * The museum serves a refreshment and offer participants a season pass to the museum. And 2. Workshops at The Storm P. museum, for up to 12 months with approximately two workshops a months. In collaboration with the museum the participants create memory material for nursing home resident with dementia. The workshop will use narrative as a method to give participants a mutual relationship that is perceived as meaningful and rewarding for each participant and in the dialogues a mutual understanding is created. The museum staff facilitates the process of storytelling using events, significant stories and artistic works by Storm P., to encourage the participants, via the method known as "narrative interview", to share similar stories from their life.

Information, event and workshops at a cartoon museum

1\. An event at the Storm P. Museum consisting of: * A guided tour at the museum * A representative from the municipal DaneAge Association will tell about the municipality's activities for the elderly. * The museum serves a refreshment and offer participants a season pass to the museum.

Information and event at a cartoon museum

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age: 65 years or older, Consultation at the general practice during the project period, Impaired social participation and often/occasionally perceive loneliness, Provided written informed consent

You may not qualify if:

  • Do not talk or understand Danish, Terminal ill, Physically not able to participate, Low score on cognitive test (OMC test)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Unit of General Practice Copenhagen

Copenhagen, Denmark

RECRUITING

MeSH Terms

Conditions

Social Isolation

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Frans B Waldorff, PhD

    Research Unit Of General Practice, Copenhagen

    PRINCIPAL INVESTIGATOR
  • Tina D Due, PhD student

    Research Unit Of General Practice, Copenhagen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Frans B Waldorff, PhD

CONTACT

Tina D Due, PhD student

CONTACT

Study Design

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

Study Record Dates

First Submitted

January 24, 2014

First Posted

January 28, 2014

Study Start

February 1, 2014

Primary Completion

August 1, 2015

Last Updated

May 23, 2014

Record last verified: 2014-01

Locations