The Impact of Social Phone Calls on Adults Who Have Had a Stroke
Primary Purpose
Stroke
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Social Phone Calls
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, phone calls, social support, loneliness, ischemic stroke
Eligibility Criteria
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
Sites / Locations
- The University of Texas Health Science Center at HoustonRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment group
Arm Description
Outcomes
Primary Outcome Measures
Feasibility as assessed by the number of participants who enrolled in the study
Feasibility as assessed by the number of participants who completed all 6 phone calls
Feasibility as assessed by the number of participants who completed all the assessments
Secondary Outcome Measures
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
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
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
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
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
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.
Full Information
NCT ID
NCT05793255
First Posted
March 15, 2023
Last Updated
March 30, 2023
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT05793255
Brief Title
The Impact of Social Phone Calls on Adults Who Have Had a Stroke
Official Title
The Impact of Social Phone Calls on Adults Who Have Had a Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 23, 2023 (Actual)
Primary Completion Date
June 12, 2023 (Anticipated)
Study Completion Date
June 12, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, phone calls, social support, loneliness, ischemic stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Social Phone Calls
Intervention Description
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
Primary Outcome Measure Information:
Title
Feasibility as assessed by the number of participants who enrolled in the study
Time Frame
post intervention (6 weeks from start of intervention)
Title
Feasibility as assessed by the number of participants who completed all 6 phone calls
Time Frame
post intervention (6 weeks from start of intervention)
Title
Feasibility as assessed by the number of participants who completed all the assessments
Time Frame
post intervention (6 weeks from start of intervention)
Secondary Outcome Measure Information:
Title
Change in loneliness as assessed by the University of California, Los Angeles (UCLA) Loneliness Scale
Description
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
Time Frame
Baseline, post intervention (6 weeks from start of intervention)
Title
Change in depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)
Description
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
Time Frame
Baseline, post intervention (6 weeks from start of intervention)
Title
Change in anxiety as assessed by the Generalized Anxiety Disorder 7 Scale (GAD 7)
Description
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
Time Frame
Baseline, post intervention (6 weeks from start of intervention)
Title
Change in social support as assessed by the Duke Social Support Index (DSSI) Scale
Description
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
Time Frame
Baseline, post intervention (6 weeks from start of intervention)
Title
Change in resilience as assessed by the brief resilience scale
Description
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
Time Frame
Baseline, post intervention (6 weeks from start of intervention)
Title
Change in pain as assessed by the Brief Pain Inventory Short Form
Description
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.
Time Frame
Baseline, post intervention (6 weeks from start of intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Beauchamp, PhD,RN
Phone
713-500-2114
Email
Jennifer.E.Beauchamp@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline Cox
Phone
713-500-2065
Email
Caroline.E.Cox@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Beauchamp, PhD, RN
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Beauchamp, PhD,RN
Phone
713-500-2114
Email
Jennifer.E.Beauchamp@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Caroline Cox
Phone
713-500-2065
Email
Caroline.E.Cox@uth.tmc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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The Impact of Social Phone Calls on Adults Who Have Had a Stroke
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