Telephone Calls for Health for Homebound Older Adults

Depression Clinical Trial

Official title:

Telephone Calls for Health for Homebound Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04595708
• Other study ID #: 2020-05-0009
• Status: Completed
• Phase: N/A
• Start date: July 6, 2020
• Est. completion date: September 26, 2020

Study information

• Verified date: March 2021
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: September 26, 2020
• Est. primary completion date: September 24, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Cognitive impairment or in a hospice program.

Related Conditions & MeSH terms

• Depression
• Loneliness
• Social Isolation

Intervention

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.

Locations

Country	Name	City	State
United States	University of Texas at Austin	Austin	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas at Austin	Meals on Wheels Central Texas

Country where clinical trial is conducted

United States, 

References & Publications (5)

Anderson, G., Thayer, C. . Loneliness and Social Connections: A National Survey of Adults 45 and Older. Washington, DC: AARP Research, September 2018. https://doi.org/10.26419/res.00246.001.

Cacioppo JT, Hughes ME, Waite LJ, Hawkley LC, Thisted RA. Loneliness as a specific risk factor for depressive symptoms: cross-sectional and longitudinal analyses. Psychol Aging. 2006 Mar;21(1):140-51. — View Citation

Derksen F, Bensing J, Lagro-Janssen A. Effectiveness of empathy in general practice: a systematic review. Br J Gen Pract. 2013 Jan;63(606):e76-84. doi: 10.3399/bjgp13X660814. Review. — View Citation

Holt-Lunstad J, Smith TB, Baker M, Harris T, Stephenson D. Loneliness and social isolation as risk factors for mortality: a meta-analytic review. Perspect Psychol Sci. 2015 Mar;10(2):227-37. doi: 10.1177/1745691614568352. Review. — View Citation

Steger MF, Kashdan TB. Depression and Everyday Social Activity, Belonging, and Well-Being. J Couns Psychol. 2009 Apr;56(2):289-300. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)