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

Sponsor
The University of Texas Health Science Center, Houston (Other)
Overall Status
Recruiting
CT.gov ID
NCT05793255
Collaborator
(none)
12
1
1
2.7
4.5

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Social Phone Calls
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Impact of Social Phone Calls on Adults Who Have Had a Stroke
Actual Study Start Date :
Mar 23, 2023
Anticipated Primary Completion Date :
Jun 12, 2023
Anticipated Study Completion Date :
Jun 12, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Feasibility as assessed by the number of participants who enrolled in the study [post intervention (6 weeks from start of intervention)]

  2. Feasibility as assessed by the number of participants who completed all 6 phone calls [post intervention (6 weeks from start of intervention)]

  3. Feasibility as assessed by the number of participants who completed all the assessments [post intervention (6 weeks from start of intervention)]

Secondary Outcome Measures

  1. Change in loneliness as assessed by the University of California, Los Angeles (UCLA) Loneliness Scale [Baseline, post intervention (6 weeks from start of intervention)]

    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

  2. Change in depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D) [Baseline, post intervention (6 weeks from start of intervention)]

    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

  3. Change in anxiety as assessed by the Generalized Anxiety Disorder 7 Scale (GAD 7) [Baseline, post intervention (6 weeks from start of intervention)]

    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

  4. Change in social support as assessed by the Duke Social Support Index (DSSI) Scale [Baseline, post intervention (6 weeks from start of intervention)]

    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

  5. Change in resilience as assessed by the brief resilience scale [Baseline, post intervention (6 weeks from start of intervention)]

    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

  6. Change in pain as assessed by the Brief Pain Inventory Short Form [Baseline, post intervention (6 weeks from start of intervention)]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The University of Texas Health Science Center at Houston Houston Texas United States 77030

Sponsors and Collaborators

  • The University of Texas Health Science Center, Houston

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jennifer Beauchamp, associate professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT05793255
Other Study ID Numbers:
  • HSC-SN-22-1084
First Posted:
Mar 31, 2023
Last Update Posted:
Mar 31, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jennifer Beauchamp, associate professor, The University of Texas Health Science Center, Houston
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 31, 2023