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.
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
- 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
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 group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Other: Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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
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
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.
- First posted30 Aug 2021
- Study start15 Jun 2021
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Senior AbuseStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- UTHealth Consortium on Aging
- Responsible party
- Principal investigator, Gabrielle Marie Hoyumpa, The University of Texas Health Science Center, Houston
- Investigators
- Gabrielle M Hoyumpa, Principal investigator, The University of Texas Health Science Center, Houston
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Social Phone Calls With Isolated Older Adults Receiving Protective Services for Abuse, Neglect and/or Exploitation
- ClinicalTrials.gov ID
- NCT05026762
- Acronym / sponsor ID
- HSC-MS-21-0411
- Conditions
- Senior Abuse
- Keywords
- depression, anxiety, loneliness, isolation, adult protective services
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- UTHealth Consortium on Aging
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 30 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Other: Treatment |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- significant cognitive impairment or incapacity as determined by their inability to complete the consent steps
- Non-English-speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TreatmentFollowing 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. | Other | Treatment |
Primary outcome
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
This is a 4 item questionnaire and each question is scored from 1(never) to 5(always) a higher number indicating more isolation
Change in Anxiety as assessed by the Geriatric Anxiety Scale
Time frame: Baseline, 6 week follow up
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
Change in Depression as assessed by the Geriatric Depression Scale Short Form
Time frame: Baseline, 6 week follow up
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
Change in Loneliness as assessed by the University of California Los Angeles (UCLA ) Loneliness Scale
Time frame: Baseline, 6 week follow up
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).
Change in perceived general health as assessed by the Self-Rated Health Question
Time frame: Baseline, 6 week follow up
The participant will rate their health as excellent, very good, good, fair or poor
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- Individual participant dataSharing planned: No
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Tele-PROTECT Therapy: Effectiveness, Empowerment, and Implementation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabrielle M Hoyumpa principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
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.