Telephone Calls for Health for Homebound Older Adults

Sponsor
University of Texas at Austin (Other)
Overall Status
Completed
CT.gov ID
NCT04595708
Collaborator
Meals on Wheels Central Texas (Other)
240
1
2
2.7
89.1

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Phone Call
N/A

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
Actual Enrollment :
240 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized controlled trialRandomized controlled trial
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.
Primary Purpose:
Treatment
Official Title:
Telephone Calls for Health for Homebound Older Adults
Actual Study Start Date :
Jul 6, 2020
Actual Primary Completion Date :
Sep 24, 2020
Actual Study Completion Date :
Sep 26, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Behavioral: 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.

No Intervention: 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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Texas at Austin Austin Texas United States 78712

Sponsors and Collaborators

  • University of Texas at Austin
  • Meals on Wheels Central Texas

Investigators

  • Principal Investigator: Maninder Kahlon, PhD, University of Texas at Austin

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Maninder Kahlon, Associate Professor, University of Texas at Austin
ClinicalTrials.gov Identifier:
NCT04595708
Other Study ID Numbers:
  • 2020-05-0009
First Posted:
Oct 20, 2020
Last Update Posted:
Mar 30, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 30, 2021