Telephone Calls for Health for Homebound Older Adults

Study Overview
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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.

Official Title
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Telephone Calls for Health for Homebound Older Adults

Conditions
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Loneliness, Social Isolation, Depression

Intervention / Treatment
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* Behavioral: Phone Call


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention - Calls<br>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<br>* 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.<br>|
| No Intervention: Control - No calls<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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 | 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. | Prior to the 4 week intervention (baseline) |