Clinical trial NCT04595708: Telephone Calls for Health for Homebound Older Adults
Official title: Telephone Calls for Health for Homebound Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Loneliness
Social Isolation
Depression
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: Meals on Wheels Central Texas
First posted: 2020-10-20
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Cognitive impairment or in a hospice program.

Primary outcomes:
measure: Loneliness as assessed by the De Jong Gierveld Loneliness Scale
timeFrame: 4 weeks
measure: Loneliness as Assessed by the UCLA Short Scale for Measuring Loneliness in Large Surveys
timeFrame: 4 weeks
Secondary outcomes:
measure: Depression as Assessed by the 8-item Depression Health Questionnaire (PHQ-8)
timeFrame: 4 weeks
measure: Anxiety as Assessed by the 7-item Generalized Anxiety Disorder Scale (GAD-7)
timeFrame: 4 weeks
measure: Health Status and Quality of Life as Assessed by the Short Form-12 Question Survey
timeFrame: 4 weeks
measure: Social Engagement as Assess by the Short Lubben Social Network Scale (LSNS)
timeFrame: 4 weeks
measure: Empathy as Assessed by The Consultation and Relational Empathy (CARE) Measure
timeFrame: After the 4 week intervention (follow-up)
measure: Toronto Empathy Questionnaire
timeFrame: Prior to the 4 week intervention (baseline)
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas at Austin
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Maninder Kahlon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.