- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05026762
The Impact of Social Phone Calls With Isolated Older Adults Receiving Protective Services for Abuse, Neglect and/or Exploitation
August 24, 2021 updated by: Gabrielle Marie Hoyumpa, The University of Texas Health Science Center, Houston
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 Overview
Study Type
Interventional
Enrollment (Anticipated)
13
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Gabrielle M Hoyumpa
- Phone Number: 210-867-0336
- Email: Gabrielle.M.Hoyumpa@uth.tmc.edu
Study Contact Backup
- Name: Jason Burnett
- Phone Number: (713) 500-3845
- Email: Jason.Burnett@uth.tmc.edu
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- The University of Texas Health Science Center at Houston
-
Contact:
- Gabrielle M Hoyumpa
- Phone Number: 210-867-0336
- Email: Gabrielle.M.Hoyumpa@uth.tmc.edu
-
Contact:
- Jason Burnett
- Phone Number: (713) 500-3845
- Email: Jason.Burnett@uth.tmc.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- significant cognitive impairment or incapacity as determined by their inability to complete the consent steps
- Non-English-speaking
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Baseline, 6 week follow up
|
|
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
|
Baseline, 6 week follow up
|
|
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 |
Baseline, 6 week follow up
|
|
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).
|
Baseline, 6 week follow up
|
|
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
|
Baseline, 6 week follow up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Gabrielle M Hoyumpa, The University of Texas Health Science Center, Houston
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 15, 2021
Primary Completion (Anticipated)
September 1, 2021
Study Completion (Anticipated)
November 1, 2021
Study Registration Dates
First Submitted
August 24, 2021
First Submitted That Met QC Criteria
August 24, 2021
First Posted (Actual)
August 30, 2021
Study Record Updates
Last Update Posted (Actual)
August 30, 2021
Last Update Submitted That Met QC Criteria
August 24, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- HSC-MS-21-0411
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Senior Abuse
-
Tomas Bata Hospital, Czech RepublicActive, not recruitingOncologic Disease | SeniorCzechia
-
McMaster UniversityOntario Drug Policy Research Network (ODPRN); Research Institute of St. Joseph...UnknownSenior High Cost Users (HCU)
-
Aalborg UniversityAalborg Municipality; Imasen Electrical Industrial Co., Ltd.CompletedPre-frail Senior AdultsDenmark
-
Centre Hospitalier Universitaire DijonCompleted
-
Florida International UniversityTerminatedDiabetes | Frailty | Senior SyndromeUnited States
-
Linkoeping UniversityKarolinska Institutet; Norwegian University of Science and Technology; City of...Not yet recruitingElder Abuse | Elder Mistreatment | Long Term Care | Abuse Physical | Abuse Verbal | Abuse Domestic | Abuse Neglect | Violence and Victimization | Abuse, SexualSweden
-
Shanghai Tong Ren HospitalRecruitingSenior Acute Coronary Syndrome Patients After PCIChina
-
Tel Aviv UniversityBar-Ilan University, IsraelEnrolling by invitationFemale | Abuse, Child | Abuse Physical | Abuse Neglect
-
Rutgers UniversityTerminatedAging | Elder Abuse | Self Neglect | Domestic AbuseUnited States
-
The Morton Center, Inc.National Institute on Alcohol Abuse and Alcoholism (NIAAA)UnknownAlcohol Dependence | Cannabis Dependence | Alcohol Abuse | Cannabis Abuse | Other Substance AbuseUnited States
Clinical Trials on Treatment
-
PfizerCompleted
-
PfizerCompleted
-
Chiesi Farmaceutici S.p.A.Completed
-
Gilead SciencesCompletedChronic Lymphocytic LeukemiaUnited States
-
JW PharmaceuticalCompletedHealthyKorea, Republic of
-
PfizerCompleted
-
AstraZenecaParexelCompleted
-
Assistance Publique - Hôpitaux de ParisRecruitingIntra-articular Fracture of the Mandibular CondyleFrance
-
New Mexico VA Healthcare SystemCompletedPost Traumatic Stress DisorderUnited States
-
PfizerCompletedHealthy VolunteersUnited States