Telephone Calls for Health for Homebound Older Adults

NCT04595708 | Completed

• 1 other identifier: 2020-05-0009
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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).

Conditions

Loneliness; Social Isolation; Depression

Outcome Measures

Primary Outcomes (2)

• 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.

  4 weeks

• 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.

  4 weeks

Secondary Outcomes (6)

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

  4 weeks

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

  4 weeks

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

  4 weeks

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

  4 weeks

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

  After the 4 week intervention (follow-up)

Study Arms (2)

Intervention - Calls

EXPERIMENTAL

Participants 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.

Behavioral: Phone Call

Control - No calls

NO INTERVENTION

Participants 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.

Interventions

Phone Call BEHAVIORAL

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.

Intervention - Calls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Cognitive impairment or in a hospice program.

Sponsors & Collaborators

• University of Texas at Austin: lead
• Meals on Wheels Central Texas: collaborator

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

Location

Related Publications (7)

• 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.

  PMID: 25910392 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 16594799 BACKGROUND

• 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.

  PMID: 20428460 BACKGROUND

• 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.

  PMID: 23336477 BACKGROUND

• 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.

  PMID: 37042110 DERIVED

• 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.

  PMID: 33620417 DERIVED

MeSH Terms

Conditions

Social Isolation; Depression

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Behavioral Symptoms

Study Officials

• Maninder Kahlon, PhD

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The individual who collected baseline and follow-up surveys was blinded to the status of the participant as part of control or intervention group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: October 14, 2020
• First Posted: October 20, 2020
• Study Start: July 6, 2020
• Primary Completion: September 24, 2020
• Study Completion: September 26, 2020
• Last Updated: March 30, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)