NCT05793255

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

March 23, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 31, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2023

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

3 months

First QC Date

March 15, 2023

Last Update Submit

January 4, 2024

Conditions

Keywords

strokephone callssocial supportlonelinessischemic stroke

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (6)

  • Change in loneliness as assessed by the University of California, Los Angeles (UCLA) Loneliness Scale

    Baseline, post intervention (6 weeks from start of intervention)

  • Change in depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)

    Baseline, post intervention (6 weeks from start of intervention)

  • Change in anxiety as assessed by the Generalized Anxiety Disorder 7 Scale (GAD 7)

    Baseline, post intervention (6 weeks from start of intervention)

  • Change in social support as assessed by the Duke Social Support Index (DSSI) Scale

    Baseline, post intervention (6 weeks from start of intervention)

  • Change in resilience as assessed by the brief resilience scale

    Baseline, post intervention (6 weeks from start of intervention)

  • +1 more secondary outcomes

Study Arms (1)

Treatment group

EXPERIMENTAL
Behavioral: Social Phone Calls

Interventions

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

Treatment group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

StrokeIschemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Jennifer Beauchamp, PhD, RN

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

March 15, 2023

First Posted

March 31, 2023

Study Start

March 23, 2023

Primary Completion

June 12, 2023

Study Completion

June 12, 2023

Last Updated

January 5, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations