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Clinical Trials/NCT04595708
NCT04595708CompletedNot Applicable

Telephone Calls for Health for Homebound Older Adults

University of Texas at Austin1 site in 1 country240 target enrollmentStarted: July 6, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
240
Locations
1
Primary Endpoint
Loneliness as assessed by the De Jong Gierveld Loneliness Scale

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Masking Description

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

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • •Cognitive impairment or in a hospice program.

Arms & Interventions

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.

Intervention: Phone Call (Behavioral)

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.

Outcomes

Primary Outcomes

Loneliness as assessed by the De Jong Gierveld Loneliness Scale

Time Frame: 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

Time Frame: 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 Outcomes

  • Toronto Empathy Questionnaire(Prior to the 4 week intervention (baseline))
  • 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))
  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Maninder Kahlon

Associate Professor

University of Texas at Austin

Study Sites (1)

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