The Impact of Social Phone Calls on Adults Who Have Had a Stroke

The purpose of this study is to see the impact of social visits, through weekly phone calls, on quality of life and health outcomes of depression, anxiety, loneliness, and self-rated health for adults who have experienced an ischemic or hemorrhagic stroke and to determine the benefit of these conversations on the student volunteer's perspective of adults who have survived a stroke

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Behavioral: Social Phone Calls

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• have a UCLA short form score of 4 or higher
• can read, write, and speak English
• have had an ischemic or hemorrhagic stroke is the past year
• have a telephone and are available for weekly phone calls
• provide informed consent agreeing to be contacted by the volunteers

Exclusion Criteria:

• reside outside of the home
• have Electronic Health Record documentation of Aphasia
• Montreal Cognitive Assessment score of <9

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment group

Behavioral: Social Phone Calls; Following the collection of baseline data, the study participant will be randomly assigned to a student volunteer to begin the social phone calls. The first phone call will be scheduled to occur within one week of the consent and baseline assessments. A minimum of one social phone call will occur each week for 6weeks. Each phone call is expected to last around 1 hour with flexibility to be shorter or longer. The calls will be unstructured and designed simply to engage in conversation with the participant. The length of the phone calls, days and times will be recorded by the volunteer along with a short journal entry describing the conversation topics and any information that stood out to the volunteer. If the stroke survivor and student volunteer wish to speak more than the designated one call a week, that will be allowed if both parties agree. The same student volunteer will conduct all six sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Feasibility as assessed by the number of participants who enrolled in the study	post intervention (6 weeks from start of intervention)
Feasibility as assessed by the number of participants who completed all 6 phone calls	post intervention (6 weeks from start of intervention)
Feasibility as assessed by the number of participants who completed all the assessments	post intervention (6 weeks from start of intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in loneliness as assessed by the University of California, Los Angeles (UCLA) Loneliness Scale	This is a 20 item questionnaire, each one is scored form 1(never) to 4(always). Scores for questions 1,5,6,9,10,15,16,19 and 20 are reversed(i.e. 1=4,2=3,3=2,4=1)and the scores for each item is then summed together, higher number indicating more loneliness	Baseline, post intervention (6 weeks from start of intervention)
Change in depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)	This is a 20 item questionnaire, each item is scored from 0(rarely or none of the time)-3 (most or all of the time) with a possible range of scores from 0-60 a higher score indicating more depression	Baseline, post intervention (6 weeks from start of intervention)
Change in anxiety as assessed by the Generalized Anxiety Disorder 7 Scale (GAD 7)	This is a 7 item questionnaire, each is scored from 0(not at all) to 3(nearly every day) a higher number indicating more anxiety	Baseline, post intervention (6 weeks from start of intervention)
Change in social support as assessed by the Duke Social Support Index (DSSI) Scale	This is a 10 item questionnaire and each is scored from 1-3,with a maximum score of 30 and higher score indicating higher levels of support	Baseline, post intervention (6 weeks from start of intervention)
Change in resilience as assessed by the brief resilience scale	This is a 6 item questionnaire and each is measured from 1(strongly disagree)-5(strongly agree) for maximum score of 30 a higher score indicating greater resilience to stressful events	Baseline, post intervention (6 weeks from start of intervention)
Change in pain as assessed by the Brief Pain Inventory Short Form	This questionnaire has 2 subscales : The first subscale is the pain severity subscale which consists of 4 questions and each are scored from 0(no pain)-10(severe pain), a higher number indicating more pain The second subscale is the pain interference score and it contains 7 items and each is scored from 0(does not interfere)-10(completely interferes) a higher number indicating worse outcome.	Baseline, post intervention (6 weeks from start of intervention)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Jennifer Beauchamp, PhD, RN, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2023
• Primary Completion (Actual): June 12, 2023
• Study Completion (Actual): June 12, 2023

Study Registration Dates

• First Submitted: March 15, 2023
• First Submitted That Met QC Criteria: March 30, 2023
• First Posted (Actual): March 31, 2023

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: stroke; ischemic stroke; social support; loneliness; phone calls
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: HSC-SN-22-1084

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No