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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05793255
• Other study ID #: HSC-SN-22-1084
• Status: Completed
• Phase: N/A
• Start date: March 23, 2023
• Est. completion date: June 12, 2023

Study information

• Verified date: January 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 12, 2023
• Est. primary completion date: June 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility as assessed by the number of participants who enrolled in the study		post intervention (6 weeks from start of intervention)
Primary	Feasibility as assessed by the number of participants who completed all 6 phone calls		post intervention (6 weeks from start of intervention)
Primary	Feasibility as assessed by the number of participants who completed all the assessments		post intervention (6 weeks from start of intervention)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)