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Completed

NCT Number: NCT04595708

Telephone Calls for Health for Homebound Older Adults

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).

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Key information

Conditions

Loneliness Behavior Behavioral Symptoms Depression Social Behavior Social Isolation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas at Austin

Austin, Texas, 78712, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Cognitive impairment or in a hospice program.

Treatment and study plan

phone call

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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

  1. Depression as Assessed by the 8-item Depression Health Questionnaire (PHQ-8)

    Time frame: 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)

    Time frame: 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

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Collaborators

  • Meals on Wheels Central Texas

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 20, 2020
Registry last updated
Mar 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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