Telephone Calls for Health for Homebound Older Adults

Not Applicable

Completed

• Conditions: Social Isolation; Loneliness; Depression

• Registration Number: NCT04595708
• Lead Sponsor: University of Texas at Austin

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.

Study Timeline

• Study Start: 2020-07-06
• Primary Completion: 2020-09-24
• Study Completion: 2020-09-26
• Study First Submitted: 2020-10-14
• Study First Submitted QC: 2020-10-14
• Study First Posted: 2020-10-20
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-26
• Last Update Posted: 2021-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

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

Exclusion Criteria

• Cognitive impairment or in a hospice program.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Loneliness as assessed by the De Jong Gierveld Loneliness Scale	4 weeks	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.
Loneliness as Assessed by the UCLA Short Scale for Measuring Loneliness in Large Surveys	4 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Toronto Empathy Questionnaire	Prior to the 4 week intervention (baseline)	The Toronto Empathy Questionnaire will be used to assess characteristics of callers that align with measures of ability to be empathetic.
Health Status and Quality of Life as Assessed by the Short Form-12 Question Survey	4 weeks	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.
Social Engagement as Assess by the Short Lubben Social Network Scale (LSNS)	4 weeks	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.
Empathy as Assessed by The Consultation and Relational Empathy (CARE) Measure	After the 4 week intervention (follow-up)	Investigators will use the CARE Measure to evaluate measures of empathy in the context of the caller/participant relationship
Depression as Assessed by the 8-item Depression Health Questionnaire (PHQ-8)	4 weeks	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.
Anxiety as Assessed by the 7-item Generalized Anxiety Disorder Scale (GAD-7)	4 weeks	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.

Trial Locations

Locations (1)

University of Texas at Austin; 🇺🇸 Austin, Texas, United States