NCT05026762

Brief Summary

The purpose of this study is to see the the impact of social visits, through weekly phones calls, on quality of life outcomes of depression, anxiety, loneliness, isolation and self-rated health for older adults visited by Adult Protective Services (APS) for abuse, neglect and/or exploitation (ANE) and to also to determine the benefit of these conversations on the medical student's perspective of aging and ANE.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 30, 2021

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

August 30, 2021

Status Verified

August 1, 2021

Enrollment Period

3 months

First QC Date

August 24, 2021

Last Update Submit

August 24, 2021

Conditions

Keywords

depressionanxietylonelinessisolationadult protective services

Outcome Measures

Primary Outcomes (5)

  • Change in Social isolation as assessed by the patient-reported outcomes measurement information system (PROMIS) Social Isolation Scale

    This is a 4 item questionnaire and each question is scored from 1(never) to 5(always) a higher number indicating more isolation

    Baseline, 6 week follow up

  • Change in Anxiety as assessed by the Geriatric Anxiety Scale

    This is a 10 item questionnaire and each question is scored form 0(not at all) to 3(most of the time),a higher number indicating more anxiety

    Baseline, 6 week follow up

  • Change in Depression as assessed by the Geriatric Depression Scale Short Form

    This is a 15 item questionnaire and each is answered either yes or no. One point is given for No to question 1, 5, 7, 11, 13 and one point for Yes to other questions. Normal ± 2 Mildly Depressed 7 ± 3 Very Depressed 12 ± 2

    Baseline, 6 week follow up

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

    A 20-item scale that measures the subjective experience of loneliness on a four-point Likert scale. Participants rate each item as either O (I often feel this way),S (I sometimes feel this way), R (I rarely feel this way), N (I never feel this way).

    Baseline, 6 week follow up

  • Change in perceived general health as assessed by the Self-Rated Health Question

    The participant will rate their health as excellent, very good, good, fair or poor

    Baseline, 6 week follow up

Study Arms (1)

Treatment

EXPERIMENTAL
Other: Treatment

Interventions

Following the collection of the baseline data, the study participant will be assigned to a volunteer(medical student) 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 6-weeks. Each phone call is expected to last up to 1 hour.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.At the end of the 6-weeks phone calls, a group session will be held with the volunteers to engage in a debriefing and narrative medicine session.

Treatment

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • recently visited by Texas Adult Protective Services for Abuse, Neglect and/or Exploitation
  • living in Harris County or a surrounding county serviced by APS District 6
  • substantiated elder mistreatment (i.e. psychological abuse, financial exploitation, sexual abuse, neglect, physical abuse) and/or self neglect
  • provide a signed or verbal release agreeing to be contacted by the volunteers
  • able to provide verbal consent to participate in the study

You may not qualify if:

  • significant cognitive impairment or incapacity as determined by their inability to complete the consent steps
  • Non-English-speaking

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

RECRUITING

MeSH Terms

Conditions

DepressionAnxiety Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Gabrielle M Hoyumpa

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Student

Study Record Dates

First Submitted

August 24, 2021

First Posted

August 30, 2021

Study Start

June 15, 2021

Primary Completion

September 1, 2021

Study Completion

November 1, 2021

Last Updated

August 30, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations