Self NeglectNCT03885063
Modifying a Telephone Based Care Program to Assess for Self-Neglect
A study testing Benjamin Rose Institute Care Consultation (BRI-CC) in people with Self Neglect, 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 assess the feasibility of enrollment, attrition, and adherence of Benjamin Rose Institute Care Consultation (BRI-CC) on unmet needs in low-income older adults who screen positive for dementia and their caregiver (CG). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Self Neglect
- What is being tested?
- Benjamin Rose Institute Care Consultation (BRI-CC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 1 Jul 2020
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- able to provide consent and understand English since most of the measures have not been translated into other languages
- has a CG willing to participate, specifically the CG must provide assistance in personal care, daily living tasks, and/or healthrelated decisions at least 3 hours per day and at least 3 days per week
- screen positive for dementia.
Who cannot join
- participant who receives home-delivered meals plans to relocate to long-term care prior to study enrollment
- reportedly moving out of the catchment area during the proposed study period
- non-English speaking
- unable to provide informed consent
- pre-diagnosed terminal illness
- non-working telephone
- visual impairment inhibiting the dyad from reading the instruments
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
The purpose of this study is to assess the feasibility of enrollment, attrition, and adherence of Benjamin Rose Institute Care Consultation (BRI-CC) on unmet needs in low-income older adults who screen positive for dementia and their caregiver (CG).
- Conditions
- Self Neglect
- Being tested
- Benjamin Rose Institute Care Consultation (BRI-CC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benjamin Rose Institute Care Consultation (BRI-CC)Behavioural
The BRI-CC is a telephone-based intervention designed for adults with chronic conditions and has been used in persons with dementia and their caregiver (CG). This assessment is guided by the use of assessment tools with domains that trigger specific and pertinent needs of the dyad such as relationship strain, depression, financial concerns, memory problems, and difficult behaviors. To address unmet needs, the care consultant and dyad develop action plans with specific action steps pertinent to the dyad. The intervention involves maintenance and support where the care consultant (CC) continues the relationship with the dyad through regular telephone contact, email and mail. CC use a web-based reporting system, to maintain and track dyad information, assessments, action plans, completed tasks, and ongoing contacts. At a minimum, the care consultant will contact the dyad by telephone once per month over the duration of the study period (i.e. 6 months).
| Study group | Role | What they receive |
|---|---|---|
| Benjamin Rose Institute Care Consultation (BRI-CC) | Experimental | Not described Receives: Behavioral: Benjamin Rose Institute Care Consultation (BRI-CC) |
| No intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as assessed by enrollment rate
enrollment rate = # enrolled / # who met inclusion criteria
Measured: 6 months
Feasibility as assessed by attrition rate
attrition rate = # not completing the study
/ # enrolled at baseline
Measured: 6 months
Feasibility as assessed by adherence rate
adherence rate = # completing all BRI-CC sessions / # enrolled in intervention group
Measured: 6 months
Feasibility as assessed by why subjects were not able to participate in BRI-CC
Measured: 6 months
Feasibility as assessed by why subjects dropped out of BRI-CC
Measured: 6 months
Secondary outcomes (18)
Unmet needs of participants who receive home-delivered meals as assessed by domains of the Unmet Needs Instrument
Responses will be entered onto a 10-item dichotomous response (need met or unmet) instrument that will be summed across six assessment domains: 1) understanding dementia, 2) accessing healthcare services, 3) accessing community services 4) accessing family services, 5) legal and financial issues, and 6) emotional support.
Measured: baseline
Unmet needs of of participants who receive home-delivered meals as assessed by domains of the Unmet Needs Instrument
Responses will be entered onto a 10-item dichotomous response (need met or unmet) instrument that will be summed across six assessment domains: 1) understanding dementia, 2) accessing healthcare services, 3) accessing community services 4) accessing family services, 5) legal and financial issues, and 6) emotional support.
Measured: 3 months
Unmet needs of participants who receive home-delivered meals as assessed by domains of the Unmet Needs Instrument
Responses will be entered onto a 10-item dichotomous response (need met or unmet) instrument that will be summed across six assessment domains: 1) understanding dementia, 2) accessing healthcare services, 3) accessing community services 4) accessing family services, 5) legal and financial issues, and 6) emotional support.
Measured: 6 months
Self Neglect as assessed by the Elder Self-Neglect Instrument (of participants who receive home-delivered meals)
The Elder Self-Neglect Assessment (ESNA) is a 25-item rating scale to assess for SN.
Each item is a 5-point Likert scale to assess the participant and the participant's home. Scores are tallied with the following suggested interpretations: (1) if high scores for social behavioral SN (B) but not environmental SN (E), then there is high risk for SN, (2) if high scores are for both B \& E, then severe unintentional SN, and (3) if high E but not B, then intentional SN. An item example asks, "Does the older adult wear dirty clothes"?
Measured: baseline
Self Neglect as assessed by the Elder Self-Neglect Instrument (of participants who receive home-delivered meals)
The Elder Self-Neglect Assessment (ESNA) is a 25-item rating scale to assess for SN. Each item is a 5-point Likert scale to assess the participant and the participant's home. Scores are tallied with the following suggested interpretations: (1) if high scores for social behavioral SN (B) but not environmental SN (E), then there is high risk for SN, (2) if high scores are for both B \& E, then severe unintentional SN, and (3) if high E but not B, then intentional SN. An item example asks, "Does the older adult wear dirty clothes"?
Measured: 6 months
Number of participants who receive home-delivered meals who were admitted to the hospital
Measured: 6 months
Number of participants who receive home-delivered meals who were readmitted to the hospital
Measured: 6 months
Number participants who receive home-delivered meals who were relocated for long term care
Measured: 6 months
Psychosocial well-being of the caregiver (CG) as assessed by the Zarit Burden Interview
The Zarit Burden Interview is a 22-item self-rated screen to assess CG burden. This measure uses a 5-point Likert scale to assess direct stress of the CG, specifically caregivers of persons with dementia. It has been shown to be sensitive to change.
Measured: baseline
Psychosocial well-being of the informal caregiver as assessed by the Zarit Burden Interview
The Zarit Burden Interview is a 22-item self-rated screen to assess CG burden. This measure uses a 5-point Likert scale to assess direct stress of the CG, specifically caregivers of persons with dementia. It has been shown to be sensitive to change.
Measured: 6 months
Caregiver depression as assessed by the Geriatric Depression Scale- Short Form
The Geriatric Depression Scale (Short-Form) (GDS-SF) is a 15-item "yes" and "no" self-rated screen to assess depression. Scores range from 0-15 with scores of 5 and greater are indicative of depression
Measured: baseline
Caregiver depression as assessed by the Geriatric Depression Scale- Short Form
The Geriatric Depression Scale (Short-Form) (GDS-SF) is a 15-item "yes" and "no" self-rated screen to assess depression. Scores range from 0-15 with scores of 5 and greater are indicative of depression
Measured: 6 months
Caregiver unmet needs as assessed by domains of the Unmet Needs Instrument
Responses will be entered onto a 10-item dichotomous response (need met or unmet) instrument that will be summed across six assessment domains: 1) understanding dementia, 2) accessing healthcare services, 3) accessing community services 4) accessing family services, 5) legal and financial issues, and 6) emotional support.
Measured: baseline
Caregiver unmet needs as assessed by domains of the Unmet Needs Instrument
Responses will be entered onto a 10-item dichotomous response (need met or unmet) instrument that will be summed across six assessment domains: 1) understanding dementia, 2) accessing healthcare services, 3) accessing community services 4) accessing family services, 5) legal and financial issues, and 6) emotional support.
Measured: 6 months
Emotional significance of pets to participants who receive home-delivered meals as assessed by the Monash Dog Owner Relationship Scale (MDORS)
Measured: baseline
Unmet Pet Care needs of participants who receive home-delivered meals as assessed by the Unmet Pet Care Needs (UPCN) scale
The UPCN scale was developed by the researchers which taps a respondent's need for information or help surrounding pet-related issues. It is based on the Benjamin Rose Institute Unmet Needs Scale (see references). Response categories are dichotomous (0=No and
1=Yes). The total score is the sum of the items noted for each measure. Higher scores indicate greater unmet need for information or help. The individual scales may be summed to create a score for total unmet need.
Measured: baseline
Barriers to pet caretaking as assessed by structured interviews over the telephone with participants who receive home-delivered meals
Measured: baseline
Potential resources and services to support unmet pet caretaking needs as assessed by structured interviews over the telephone with participants who receive home-delivered meals
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start1 Apr 2019
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Why it stopped: COVID-19 pandemic interrupted study proceudres
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self NeglectStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Constance Johnson, The University of Texas Health Science Center, Houston
- Investigators
- Sabrina Pickens, PhD, RN, MSN, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03885063
- Sponsor's protocol ID
- HSC-SN-18-0741
- Status last verified
- Jun 2025
- First submitted
- 19 Mar 2019
- Last updated
- 1 Jul 2025
- Results posted
- 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 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modifying a Telephone Based Care Program to Assess for Self-Neglect
- ClinicalTrials.gov ID
- NCT03885063
- Acronym / sponsor ID
- HSC-SN-18-0741
- Conditions
- Self Neglect
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 pandemic interrupted study proceudres
- Enrolment
- 22 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 21 Mar 2019 (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 assess the feasibility of enrollment, attrition, and adherence of Benjamin Rose Institute Care Consultation (BRI-CC) on unmet needs in low-income older adults who screen positive for dementia and their caregiver (CG).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Benjamin Rose Institute Care Consultation (BRI-CC) | Experimental | Behavioral: Benjamin Rose Institute Care Consultation (BRI-CC) |
| No intervention | No intervention | – |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- able to provide consent and understand English since most of the measures have not been translated into other languages
- has a CG willing to participate, specifically the CG must provide assistance in personal care, daily living tasks, and/or healthrelated decisions at least 3 hours per day and at least 3 days per week
- screen positive for dementia.
Key exclusion criteria (7 listed)
- participant who receives home-delivered meals plans to relocate to long-term care prior to study enrollment
- reportedly moving out of the catchment area during the proposed study period
- non-English speaking
- unable to provide informed consent
- pre-diagnosed terminal illness
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 |
|---|---|---|
| Benjamin Rose Institute Care Consultation (BRI-CC)The BRI-CC is a telephone-based intervention designed for adults with chronic conditions and has been used in persons with dementia and their caregiver (CG). This assessment is guided by the use of assessment tools with domains that trigger specific and pertinent needs of the dyad such as relationship strain, depression, financial concerns, memory problems, and difficult behaviors. To address unmet needs, the care consultant and dyad develop action plans with specific action steps pertinent to the dyad. The intervention involves maintenance and support where the care consultant (CC) continues the relationship with the dyad through regular telephone contact, email and mail. CC use a web-based reporting system, to maintain and track dyad information, assessments, action plans, completed tasks, and ongoing contacts. At a minimum, the care consultant will contact the dyad by telephone once per month over the duration of the study period (i.e. 6 months). | Behavioural | Benjamin Rose Institute Care Consultation (BRI-CC) |
Primary outcome
Feasibility as assessed by enrollment rate
Time frame: 6 months
enrollment rate = # enrolled / # who met inclusion criteria
Feasibility as assessed by attrition rate
Time frame: 6 months
attrition rate = # not completing the study / # enrolled at baseline
Feasibility as assessed by adherence rate
Time frame: 6 months
adherence rate = # completing all BRI-CC sessions / # enrolled in intervention group
Feasibility as assessed by why subjects were not able to participate in BRI-CC
Time frame: 6 months
Feasibility as assessed by why subjects dropped out of BRI-CC
Time frame: 6 months
18 secondary outcomes
Unmet needs of participants who receive home-delivered meals as assessed by domains of the Unmet Needs Instrument
Time frame: baseline
Unmet needs of of participants who receive home-delivered meals as assessed by domains of the Unmet Needs Instrument
Time frame: 3 months
Unmet needs of participants who receive home-delivered meals as assessed by domains of the Unmet Needs Instrument
Time frame: 6 months
Self Neglect as assessed by the Elder Self-Neglect Instrument (of participants who receive home-delivered meals)
Time frame: baseline
Self Neglect as assessed by the Elder Self-Neglect Instrument (of participants who receive home-delivered meals)
Time frame: 6 months
Number of participants who receive home-delivered meals who were admitted to the hospital
Time frame: 6 months
Number of participants who receive home-delivered meals who were readmitted to the hospital
Time frame: 6 months
Number participants who receive home-delivered meals who were relocated for long term care
Time frame: 6 months
Psychosocial well-being of the caregiver (CG) as assessed by the Zarit Burden Interview
Time frame: baseline
Psychosocial well-being of the informal caregiver as assessed by the Zarit Burden Interview
Time frame: 6 months
Caregiver depression as assessed by the Geriatric Depression Scale- Short Form
Time frame: baseline
Caregiver depression as assessed by the Geriatric Depression Scale- Short Form
Time frame: 6 months
Caregiver unmet needs as assessed by domains of the Unmet Needs Instrument
Time frame: baseline
Caregiver unmet needs as assessed by domains of the Unmet Needs Instrument
Time frame: 6 months
Emotional significance of pets to participants who receive home-delivered meals as assessed by the Monash Dog Owner Relationship Scale (MDORS)
Time frame: baseline
Unmet Pet Care needs of participants who receive home-delivered meals as assessed by the Unmet Pet Care Needs (UPCN) scale
Time frame: baseline
Barriers to pet caretaking as assessed by structured interviews over the telephone with participants who receive home-delivered meals
Time frame: baseline
Potential resources and services to support unmet pet caretaking needs as assessed by structured interviews over the telephone with participants who receive home-delivered meals
Time frame: baseline
Results and safety
The study was stopped early (reason given: COVID-19 pandemic interrupted study proceudres). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Individual participant dataSharing planned: No
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Replication and Evaluation of the RISE-APS Model In New Contexts
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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.
Sabrina Pickens, PhD, RN, MSN 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 Benjamin Rose Institute Care Consultation (BRI-CC) in people with Self Neglect, 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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 1 Jul 2025. 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?
The study was stopped early (reason given: COVID-19 pandemic interrupted study proceudres). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as assessed by enrollment rate (time frame: 6 months). 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 1 Jul 2025.