Quality of LifeNCT02047435
Integrating Lonely Elderly Patients in Workshops in a Cartoon Museum: An Efficacy Study
A study testing Information, event and workshops at a cartoon museum and Information and event at a cartoon museum in people with Quality of Life and Social Isolation, run by Research Unit Of General Practice, Copenhagen at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Social Isolation, Loneliness
- What is being tested?
- Information, event and workshops at a cartoon museum and Information and event at a cartoon museum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2014to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- Do not talk or understand Danish, Terminal ill, Physically not able to participate, Low score on cognitive test (OMC test)
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Research Unit of General Practice Copenhagen
Copenhagen
About this 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.
Read more
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.
Read the 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.
- Conditions
- Quality of Life, Social Isolation, Loneliness
- Being tested
- Information, event and workshops at a cartoon museum, Information and event at a cartoon museum
- Keywords
- Social participation, Loneliness, General practice, Cultural institutions
- Medical subject headings
- Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Information, event and workshops at a cartoon museumBehavioural
- 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 museumBehavioural
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Information, event and workshops at a cartoon museum | Experimental | Not described Receives: Behavioral: Information, event and workshops at a cartoon museum |
| Information and event at a cartoon museum | Active comparator | Not described Receives: Behavioral: Information and event at a cartoon museum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference from baseline in summary Index of EuroQol -5D
Health related quality of life measured by EuroQol -5D
Measured: Baseline, 9 months and 18 months
Secondary outcomes (7)
Score of MMSE test
Score of Mini Mental State Examination (MMSE).
Measured: Baseline, 9 months, 18 months
Score of GDS-15 items
Score of the Geriatric Depression Scale (GDS)
Measured: baseline, 9 months and 18 months
"Timed up and go" test
Measured: Baseline, 9 months and 18 months
Consultation at general practice and hospital admission
Measured: Baseline, 9 months and 18 months
Score on Mobility-Tiredness scale
Measured: Baseline, 9 months and 18 months
Score on social participation scale
Based on three items. The analysis is made on the individual items as well as the total score
Measured: Baseline, 9 months and 18 months
Loneliness
Based on an item with four categories.
Measured: Baseline, 9 months and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Research Unit Of General Practice, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- The Storm P. Museum, University College Absalon, EGV Foundation, Danish Agency for Culture
- Responsible party
- Principal investigator, Frans Boch Waldorff, Research Unit Of General Practice, Copenhagen
- Investigators
- Frans B Waldorff, PhD, Principal investigator, Research Unit Of General Practice, CopenhagenTina D Due, PhD student, Principal investigator, Research Unit Of General Practice, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02047435
- Sponsor's protocol ID
- Storm-P-2014
- Status last verified
- Jan 2014
- First submitted
- 24 Jan 2014
- Last updated
- 23 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Lonely Elderly Patients in Workshops in a Cartoon Museum: An Efficacy Study
- ClinicalTrials.gov ID
- NCT02047435
- Acronym / sponsor ID
- Storm-P-2014
- Conditions
- Quality of Life, Social Isolation, Loneliness
- Keywords
- Social participation, Loneliness, General practice, Cultural institutions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Research Unit Of General Practice, CopenhagenUniversity, hospital or other
- Collaborators
- The Storm P. Museum, University College Absalon, EGV Foundation, Danish Agency for Culture
- Study start
- Feb 2014
- Primary completion
- Aug 2015 (estimated)
- First posted
- 28 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Do not talk or understand Danish, Terminal ill, Physically not able to participate, Low score on cognitive test (OMC test)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Information, event and workshops at a cartoon museum1. 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. | Behavioural | Information, event and workshops at a cartoon museum |
| Information and event at a cartoon museum1. 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. | Behavioural | Information and event at a cartoon museum |
Primary outcome
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
7 secondary outcomes
Score of MMSE test
Time frame: Baseline, 9 months, 18 months
Score of GDS-15 items
Time frame: baseline, 9 months and 18 months
"Timed up and go" test
Time frame: Baseline, 9 months and 18 months
Consultation at general practice and hospital admission
Time frame: Baseline, 9 months and 18 months
Score on Mobility-Tiredness scale
Time frame: Baseline, 9 months and 18 months
Score on social participation scale
Time frame: Baseline, 9 months and 18 months
Loneliness
Time frame: Baseline, 9 months and 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frans B Waldorff, PhD principal investigator
Research Unit Of General Practice, Copenhagen
Tina D Due, PhD student principal investigator
Research Unit Of General Practice, Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Information, event and workshops at a cartoon museum and Information and event at a cartoon museum in people with Quality of Life and Social Isolation, run by Research Unit Of General Practice, Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frans B Waldorff, PhD (+ 45 35327129, fransw@sund.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference from baseline in summary Index of EuroQol -5D (time frame: Baseline, 9 months and 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2014.