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Senior AbuseNCT05026762

The Impact of Social Phone Calls With Isolated Older Adults Receiving Protective Services for Abuse, Neglect and/or Exploitation

A study testing Treatment in people with Senior Abuse, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Senior Abuse
What is being tested?
Treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteUnited States
Study dates
15 Jun 2021to 1 Nov 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site, 1 recruiting
  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

    Gabrielle M Hoyumpa, 210-867-0336, Gabrielle.M.Hoyumpa@uth.tmc.edu

    Jason Burnett, (713) 500-3845, Jason.Burnett@uth.tmc.edu

    Recruiting

Other trials in United States

About this study

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.

Conditions
Senior Abuse
Being tested
Treatment
Keywords
depression, anxiety, loneliness, isolation, adult protective services
Medical subject headings
Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TreatmentOther

    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.

Study groups in NCT05026762
Study groupRoleWhat they receive
TreatmentExperimentalNot described
Receives: Other: Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline, 6 week follow up

  2. 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

    Measured: Baseline, 6 week follow up

  3. 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

    Measured: Baseline, 6 week follow up

  4. 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).

    Measured: Baseline, 6 week follow up

  5. 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

    Measured: Baseline, 6 week follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2021
  2. Study start15 Jun 2021
  3. Primary completion1 Sep 2021 (estimated)
  4. Study completion1 Nov 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05026762
Sponsor's protocol ID
HSC-MS-21-0411
Status last verified
Aug 2021
First submitted
24 Aug 2021
Last updated
30 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Treatment in people with Senior Abuse, run by The University of Texas Health Science Center, Houston at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Gabrielle M Hoyumpa (210-867-0336, Gabrielle.M.Hoyumpa@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Social isolation as assessed by the patient-reported outcomes measurement information system (PROMIS) Social Isolation Scale (time frame: Baseline, 6 week follow up). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2021.

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