Integrating Lonely Elderly Patients in Workshops in a Cartoon Museum: An Efficacy Study

Quality of Life Clinical Trial

Official title:

Integrating Lonely Elderly Patients in Workshops in a Cartoon Museum: An Efficacy Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02047435
• Other study ID #: Storm-P-2014
• Status: Recruiting
• Phase: N/A
• First received: January 24, 2014
• Last updated: May 22, 2014
• Start date: February 2014

Study information

• Verified date: January 2014
• Source: Research Unit Of General Practice, Copenhagen
• Contact: Frans B Waldorff, PhD
• Phone: + 45 35327129
• Email: fransw[@]sund.ku.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Description:

Background:

Social relations are important to people and it affects their quality of life, morbidity and mortality. This is especially true among older people and social relations are also important for the management of chronic diseases. Those with strong social relations are less sick, and recover faster if they become sick. There is also a connection between social relations and death, as people with many social relations are more likely to live longer than people with few social relations. In Denmark it is assumed that poor social relationships causes between 1000-1500 deaths per year, equivalent to about 2% of all deaths.

This is a randomised controlled trial studying the effect of including older people with poor 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.

Hypothesis:

The hypothesis is, that by including older lonely people with a poor 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 as well as mortality and nursing home placement at long term.

The intervention:

Both the intervention and the comparison group will be invited to an event at the Storm P. Museum.

This event consist of

• A guided tour of the collection with a presentation on Storm P. 's life and artistic work.

• A representative from the municipal DaneAge Association will subsequently tell about the municipality's activities for the elderly.

• The museum will serve a refreshment and offer participants a season pass to the museum.

In addition the intervention group will be invited to participate in a series of workshops at the Storm P. Museum with scheduled meetings twice a month. In collaboration with the museum, participants at these workshops will create memory material for nursing home residents 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. Storytelling is central in creating a cognitive, meaningful and holistic life. In our dialogues we create a mutual understanding. Stories are central to people and is used in making sense in transitions and essential decisions in your life.

The museum facilitates the process of storytelling using events, significant stories and artistic works by Storm P., and encourage the participants, via the method known as "narrative interview", to share similar stories from their life. This will not only benefit the participants, but also act as crucial empirical data collected via journal keeping for this project.

The intervention is planned to last for up to 12 months and outcome measures are collected at baseline, 9 months and at 18 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

Patients consulting their general practitioner in the municipality of Frederiksberg during february/Marts 2014. Who in a questionnaire have a low score of social participation and answers they often feel lonely.

The participants are allocated to the study consecutively.

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Loneliness
• Quality of Life
• Social Isolation

Intervention

Behavioral:
• Information, event and workshops at a cartoon museum
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 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 and event 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.

Locations

Country	Name	City	State
Denmark	Research Unit of General Practice Copenhagen	Copenhagen

Sponsors (5)

Lead Sponsor	Collaborator
Research Unit Of General Practice, Copenhagen	Danish Agency for Culture, EGV Foundation, The Storm P. Museum, University College Sjælland

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	All cause mortality	A long term follow up analysis.	36 month	No
Other	Permanent nursing home placement	Long term follow up analysis	36 month	No
Other	Health economic analysis		36 month	No
Primary	Difference from baseline in summary Index of EuroQol -5D	Health related quality of life measured by EuroQol -5D	Baseline, 9 months and 18 months	No
Secondary	Score of MMSE test	Score of Mini Mental State Examination (MMSE).	Baseline, 9 months, 18 months	No
Secondary	Score of GDS-15 items	Score of the Geriatric Depression Scale (GDS)	baseline, 9 months and 18 months	No
Secondary	"Timed up and go" test		Baseline, 9 months and 18 months	No
Secondary	Consultation at general practice and hospital admission		Baseline, 9 months and 18 months	No
Secondary	Score on Mobility-Tiredness scale		Baseline, 9 months and 18 months	No
Secondary	Score on social participation scale	Based on three items. The analysis is made on the individual items as well as the total score	Baseline, 9 months and 18 months	No
Secondary	Loneliness	Based on an item with four categories.	Baseline, 9 months and 18 months	No