An interventional study of Phone Call in Loneliness, Social Isolation and Depression, sponsored by University of Texas at Austin. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-30.
Sponsored by University of Texas at Austin · Not applicable, Interventional, and Treatment
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).
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 240 is above the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →University of Texas at Austin is the lead sponsor of 319 studies on the registry; 78 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.
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Exclusion Criteria:
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
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.
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.
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.
Time frame: 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.
Time frame: 4 weeks
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.
Time frame: 4 weeks
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.
Time frame: 4 weeks
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.
Time frame: 4 weeks
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.
Time frame: 4 weeks
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
Time frame: After the 4 week intervention (follow-up)
Toronto Empathy Questionnaire
The Toronto Empathy Questionnaire will be used to assess characteristics of callers that align with measures of ability to be empathetic.
Time frame: Prior to the 4 week intervention (baseline)
Plan to share: No
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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University of Texas at Austin