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LonelinessNCT04595708

Telephone Calls for Health for Homebound Older Adults

A study testing Phone Call in people with Loneliness and Social Isolation, run by University of Texas at Austin at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A randomized controlled trial of the effect of 4 weeks of regular check-in calls, up to 5 per week based on participant's choice and 2 survey collection calls and possible referral of other services, versus no daily check-in calls, on self-reported loneliness measures for current Meals on Wheels participants (MOW). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Loneliness, Social Isolation, Depression
What is being tested?
Phone Call
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
1 siteUnited States
Study dates
6 Jul 2020to 26 Sep 2020
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adult (18+) clients of Meals on Wheels of Central Texas

Who cannot join

  • Cognitive impairment or in a hospice program.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas at Austin

    Austin, Texas, 78712

Other trials in United States

About this study

A randomized controlled trial of the effect of 4 weeks of regular check-in calls, up to 5 per week based on participant's choice and 2 survey collection calls and possible referral of other services, versus no daily check-in calls, on self-reported loneliness measures for current Meals on Wheels participants (MOW).

Read the detailed description

The intervention arm will include 125 MOW clients to receive a call of between 5 - 10 minutes in length each by a consistent caller, five times a week, Monday through Friday for 4 consecutive weeks to check in on them. After the first week of calls, subjects in the intervention arm will be asked if the frequency of calls is acceptable or if they would like to reduce the call frequency, potentially to a minimum of twice per week.

Brief guidance and training will be provided for the daily conversation to maximize time spent speaking by the recipient but otherwise, the calls are unscripted other than specific prompts to ask about the recipient's general sense of well-being. "How are you doing today?"

The control Arm will include 125 MOW clients who will be randomized to a control group that will not receive the intervention calls. The control group will receive calls from a member of the research team at the beginning of the study to collect baseline survey data and at the post-4-week period to collect post-study survey data.

Being tested
Phone Call
Medical subject headings
Social Isolation, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Phone CallBehavioural

    Calls were made by volunteers trained to engage with participants. Call structure was unscripted and call length was recommended to be between 5-10 min.

Study groups in NCT04595708
Study groupRoleWhat they receive
Intervention - CallsExperimentalParticipants randomized to the intervention will receive a call of between 5 - 10 minutes in length each by a consistent caller, five times a week, Monday through Friday for 4 consecutive weeks to check in on them. After the first week of calls, subjects in the intervention arm will be asked if the frequency of calls is acceptable or if they would like to reduce the call frequency, potentially to a minimum of twice per week.
Receives: Behavioral: Phone Call
Control - No callsNo interventionParticipants randomized to a control group will not receive the intervention calls. The control group will receive calls from a member of the research team at the beginning of the study to collect baseline survey data and at the post-4-week period to collect post-study survey data.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Loneliness as assessed by the De Jong Gierveld Loneliness Scale

    Investigators will use the De Jong Gierveld Loneliness 6-Item Scale for Overall, Emotional, and Social Loneliness. Scored from 0-6, a score of 0 indicates least lonely while a score of 6 indicates most lonely.

    Measured: 4 weeks

  2. Loneliness as Assessed by the UCLA Short Scale for Measuring Loneliness in Large Surveys

    Investigators will use the UCLA Short Scale for Measuring Loneliness in Large Surveys to measure loneliness. Scored from 3-9, higher scores indicate greater degrees of loneliness.

    Measured: 4 weeks

Secondary outcomes (6)

  1. Depression as Assessed by the 8-item Depression Health Questionnaire (PHQ-8)

    Investigators will use the Depression Patient Health Questionnaire (PHQ-8) to measure depression. Scored from 0-3, and a score of 0 indicates lower levels of depression while a score of 3 indicates higher levels of depression.

    Measured: 4 weeks

  2. Anxiety as Assessed by the 7-item Generalized Anxiety Disorder Scale (GAD-7)

    Investigators will use the Generalized Anxiety Disorder Scale (GAD-7) to measure anxiety. Scored from 0-3, and a score of 0 indicates lower levels of anxiety while a score of 3 indicates higher levels of anxiety.

    Measured: 4 weeks

  3. Health Status and Quality of Life as Assessed by the Short Form-12 Question Survey

    Investigators will use the Short Form-12 question survey to measure physical and mental health status. Summary scores range from 0-100, with higher scores indicating a better self-reported level of health.

    Measured: 4 weeks

  4. Social Engagement as Assess by the Short Lubben Social Network Scale (LSNS)

    Investigators will use the 6-item Short Lubben Social Network Scale to measure social engagement. For the LSNS-6, the score ranges between 0 and 30, with a higher score indicating more social engagement.

    Measured: 4 weeks

  5. Empathy as Assessed by The Consultation and Relational Empathy (CARE) Measure

    Investigators will use the CARE Measure to evaluate measures of empathy in the context of the caller/participant relationship

    Measured: After the 4 week intervention (follow-up)

  6. Toronto Empathy Questionnaire

    The Toronto Empathy Questionnaire will be used to assess characteristics of callers that align with measures of ability to be empathetic.

    Measured: Prior to the 4 week intervention (baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2020
  2. Study start6 Jul 2020
  3. Primary completion24 Sep 2020
  4. Study completion26 Sep 2020

Resources

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
Model description
Randomized controlled trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04595708
Sponsor's protocol ID
2020-05-0009
Status last verified
Mar 2021
First submitted
14 Oct 2020
Last updated
30 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Holt-Lunstad J, Smith TB, Baker M, Harris T, Stephenson D. Loneliness and social isolation as risk factors for mortality: a meta-analytic review. Perspect Psychol Sci. 2015 Mar;10(2):227-37. doi: 10.1177/1745691614568352.

    PubMed 25910392

  • Anderson, G., Thayer, C. . Loneliness and Social Connections: A National Survey of Adults 45 and Older. Washington, DC: AARP Research, September 2018. https://doi.org/10.26419/res.00246.001.

  • Cacioppo JT, Hughes ME, Waite LJ, Hawkley LC, Thisted RA. Loneliness as a specific risk factor for depressive symptoms: cross-sectional and longitudinal analyses. Psychol Aging. 2006 Mar;21(1):140-51. doi: 10.1037/0882-7974.21.1.140.

    PubMed 16594799

  • Steger MF, Kashdan TB. Depression and Everyday Social Activity, Belonging, and Well-Being. J Couns Psychol. 2009 Apr;56(2):289-300. doi: 10.1037/a0015416.

    PubMed 20428460

  • Derksen F, Bensing J, Lagro-Janssen A. Effectiveness of empathy in general practice: a systematic review. Br J Gen Pract. 2013 Jan;63(606):e76-84. doi: 10.3399/bjgp13X660814.

    PubMed 23336477

  • Kahlon MK, Aksan N, Aubrey R. Effect of a Layperson-Delivered Telephone Program for People With Depressive Symptoms. Psychiatr Serv. 2023 Nov 1;74(11):1176-1179. doi: 10.1176/appi.ps.20220440. Epub 2023 Apr 12.

    PubMed 37042110

  • Kahlon MK, Aksan N, Aubrey R, Clark N, Cowley-Morillo M, Jacobs EA, Mundhenk R, Sebastian KR, Tomlinson S. Effect of Layperson-Delivered, Empathy-Focused Program of Telephone Calls on Loneliness, Depression, and Anxiety Among Adults During the COVID-19 Pandemic: A Randomized Clinical Trial. JAMA Psychiatry. 2021 Jun 1;78(6):616-622. doi: 10.1001/jamapsychiatry.2021.0113.

    PubMed 33620417

Questions about this trial

What is this clinical trial studying?

A study testing Phone Call in people with Loneliness and Social Isolation, run by University of Texas at Austin at 1 site in United States.

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: finished, as of the sponsor's last update on 30 Mar 2021. 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 United States. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 as assessed by the De Jong Gierveld Loneliness Scale (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04595708, which also lists 7 linked publications.

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 Mar 2021.

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