LonelinessNCT04797026
Penpal Loneliness Project
A study testing Letters to increase social connection with goal to alleviate loneliness in people with Loneliness, run by Mayo Clinic.
Trial summary
The purpose of this research is to study whether sending letters helps reduce loneliness for either the facility resident or the teenager. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Loneliness
- What is being tested?
- Letters to increase social connection with goal to alleviate loneliness
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2021to 20 Mar 2022
- 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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Care facility residents with capacity to make decisions:
- Measured via their most recent cognitive assessment;
- Subjectively measured via nursing staff.
- High school students will be invited via recommendation of their instructors and school administrative staff:
- Parental permission will be required.
Who cannot join
- Care facility residents that have significant cognitive impairment.
- Residents who lack decision-making capacity.
About this study
Official title: Reducing Loneliness With Penpal Connections
The purpose of this research is to study whether sending letters helps reduce loneliness for either the facility resident or the teenager.
Read the detailed description
Hypothesis: Our hypothesis is that a social program connecting patients in residential care facilities with high school students through monthly letter writing would positively impact quality of life for both, reducing quantitative and qualitiative measures of loneliness
Aims, purpose, or objectives:
Our objective is to reduce loneliness and increase quality of life for patients residing in residential care facilities and for high school students.
Background (Include relevant experience, gaps in current knowledge, preliminary data, etc.):
In response to the Covid pandemic, to protect their residents, residential care facilities have implemented restrictions limiting visitors as well as social activities. Anecdoctally this has negative impacted the quality of life of those residents, increasing their loneliness. Previous studies have shown positive impact of intergenerational programs including penpal programs.
- Conditions
- Loneliness
- Being tested
- Letters to increase social connection with goal to alleviate loneliness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Letters to increase social connection with goal to alleviate lonelinessOther
Also called Letters
Our hypothesis is that a social program connecting patients in residential care facilities with high school students through monthly letter writing would positively impact quality of life for both, reducing quantitative and qualitiative measures of loneliness
| Study group | Role | What they receive |
|---|---|---|
| Penpal Program to Alleviate Loneliness | Experimental | A social program connecting patients in residential care facilities with high school students through monthly letter writing would positively impact quality of life for both, reducing quantitative and qualitative measures of loneliness Receives: Other: Letters to increase social connection with goal to alleviate loneliness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loneliness Alleviation with Letter Writing
Writing letters between Long Term Care Residents and Students: Increasing Connection to Alleviate Loneliness
Measured: 6 months; may be extended
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start15 Sep 2021 (estimated)
- Primary completion15 Mar 2022 (estimated)
- Study completion20 Mar 2022 (estimated)
Why it stopped: Study terminated due to difficulties enrolling given skilled nursing facility staff shortages
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LonelinessStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 5 care facility residents paired with a similar amount of students as a pilot. If this program is successful, we will plan to amend IRB to include larger numbers
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan B. Laabs, Mayo Clinic
- Investigators
- Susan Laabs, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04797026
- Sponsor's protocol ID
- 20-009976
- Status last verified
- Dec 2021
- First submitted
- 11 Mar 2021
- Last updated
- 30 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Loneliness With Penpal Connections
- ClinicalTrials.gov ID
- NCT04797026
- Acronym / sponsor ID
- 20-009976
- Conditions
- Loneliness
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study terminated due to difficulties enrolling given skilled nursing facility staff shortages
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 15 Sep 2021 (estimated)
- Primary completion
- 15 Mar 2022 (estimated)
- Study completion
- 20 Mar 2022 (estimated)
- First posted
- 15 Mar 2021 (actual)
- 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.
The purpose of this research is to study whether sending letters helps reduce loneliness for either the facility resident or the teenager.
Detailed description
Hypothesis: Our hypothesis is that a social program connecting patients in residential care facilities with high school students through monthly letter writing would positively impact quality of life for both, reducing quantitative and qualitiative measures of loneliness
Aims, purpose, or objectives:
Our objective is to reduce loneliness and increase quality of life for patients residing in residential care facilities and for high school students.
Background (Include relevant experience, gaps in current knowledge, preliminary data, etc.):
In response to the Covid pandemic, to protect their residents, residential care facilities have implemented restrictions limiting visitors as well as social activities. Anecdoctally this has negative impacted the quality of life of those residents, increasing their loneliness. Previous studies have shown positive impact of intergenerational programs including penpal programs.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 5 care facility residents paired with a similar amount of students as a pilot. If this program is successful, we will plan to amend IRB to include larger numbers
| Arm | Type | Receives |
|---|---|---|
| Penpal Program to Alleviate Loneliness | Experimental | Other: Letters to increase social connection with goal to alleviate lonelinessA social program connecting patients in residential care facilities with high school students through monthly letter writing would positively impact quality of life for both, reducing quantitative and qualitative measures of loneliness |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Care facility residents with capacity to make decisions:
- Measured via their most recent cognitive assessment;
- Subjectively measured via nursing staff.
- High school students will be invited via recommendation of their instructors and school administrative staff:
- Parental permission will be required.
Key exclusion criteria (2 listed)
- Care facility residents that have significant cognitive impairment.
- Residents who lack decision-making capacity.
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 |
|---|---|---|
| Letters to increase social connection with goal to alleviate lonelinessAlso: LettersOur hypothesis is that a social program connecting patients in residential care facilities with high school students through monthly letter writing would positively impact quality of life for both, reducing quantitative and qualitiative measures of loneliness | Other | Penpal Program to Alleviate Loneliness |
Primary outcome
Loneliness Alleviation with Letter Writing
Time frame: 6 months; may be extended
Writing letters between Long Term Care Residents and Students: Increasing Connection to Alleviate Loneliness
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2021.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Susan Laabs, MD principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A study testing Letters to increase social connection with goal to alleviate loneliness in people with Loneliness, run by Mayo Clinic.
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 5 inclusion and 2 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: withdrawn, as of the sponsor's last update on 30 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Loneliness Alleviation with Letter Writing (time frame: 6 months; may be extended). 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 30 Dec 2021.