Telephone Calls for Health for Homebound Older Adults

NCT ID: NCT04595708

Last Updated: 2021-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-06

Study Completion Date

2020-09-26

Brief Summary

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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

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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.

Conditions

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Loneliness Social Isolation Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The individual who collected baseline and follow-up surveys was blinded to the status of the participant as part of control or intervention group.

Study Groups

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Intervention - Calls

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.

Group Type EXPERIMENTAL

Phone Call

Intervention Type 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.

Control - No calls

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Phone Call

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 Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Cognitive impairment or in a hospice program.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Meals on Wheels Central Texas

OTHER

Sponsor Role collaborator

University of Texas at Austin

OTHER

Sponsor Role lead

Responsible Party

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Maninder Kahlon

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maninder Kahlon, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Austin

Locations

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University of Texas at Austin

Austin, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 25910392 (View on PubMed)

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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 16594799 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20428460 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23336477 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37042110 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33620417 (View on PubMed)

Other Identifiers

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2020-05-0009

Identifier Type: -

Identifier Source: org_study_id

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