- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02047435
Integrating Lonely Elderly Patients in Workshops in a Cartoon Museum: An Efficacy Study
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.
Study Overview
Status
Conditions
Detailed 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Frans B Waldorff, PhD
- Phone Number: + 45 35327129
- Email: fransw@sund.ku.dk
Study Contact Backup
- Name: Tina D Due, PhD student
- Phone Number: + 45 35327167
- Email: tina.due@sund.ku.dk
Study Locations
-
-
-
Copenhagen, Denmark
- Recruiting
- Research Unit of General Practice Copenhagen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Information, event and workshops at a cartoon museum
|
|
Active Comparator: Information and event at a cartoon museum
|
1. An event at the Storm P. Museum consisting of:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference from baseline in summary Index of EuroQol -5D
Time Frame: Baseline, 9 months and 18 months
|
Health related quality of life measured by EuroQol -5D
|
Baseline, 9 months and 18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Score of MMSE test
Time Frame: Baseline, 9 months, 18 months
|
Score of Mini Mental State Examination (MMSE).
|
Baseline, 9 months, 18 months
|
Score of GDS-15 items
Time Frame: baseline, 9 months and 18 months
|
Score of the Geriatric Depression Scale (GDS)
|
baseline, 9 months and 18 months
|
"Timed up and go" test
Time Frame: Baseline, 9 months and 18 months
|
Baseline, 9 months and 18 months
|
|
Consultation at general practice and hospital admission
Time Frame: Baseline, 9 months and 18 months
|
Baseline, 9 months and 18 months
|
|
Score on Mobility-Tiredness scale
Time Frame: Baseline, 9 months and 18 months
|
Baseline, 9 months and 18 months
|
|
Score on social participation scale
Time Frame: Baseline, 9 months and 18 months
|
Based on three items.
The analysis is made on the individual items as well as the total score
|
Baseline, 9 months and 18 months
|
Loneliness
Time Frame: Baseline, 9 months and 18 months
|
Based on an item with four categories.
|
Baseline, 9 months and 18 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
All cause mortality
Time Frame: 36 month
|
A long term follow up analysis.
|
36 month
|
Permanent nursing home placement
Time Frame: 36 month
|
Long term follow up analysis
|
36 month
|
Health economic analysis
Time Frame: 36 month
|
36 month
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Frans B Waldorff, PhD, Research Unit Of General Practice, Copenhagen
- Principal Investigator: Tina D Due, PhD student, Research Unit Of General Practice, Copenhagen
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Storm-P-2014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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