Modifying a Telephone Based Care Program to Assess for Self-Neglect

• ClinicalTrials.gov Identifier: NCT03885063
• Recruitment Status: Not yet recruiting
• First Posted: March 21, 2019
• Last Update Posted: March 21, 2019
• Sponsor: The University of Texas Health Science Center, Houston
• Information provided by (Responsible Party): Sabrina L Pickens, The University of Texas Health Science Center, Houston

Study Description

Brief 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).

Condition or disease	Intervention/treatment	Phase
Self Neglect	Behavioral: Benjamin Rose Institute Care Consultation (BRI-CC)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Care Provider)
• Primary Purpose: Supportive Care
• Official Title: Modifying a Telephone Based Care Program to Assess for Self-Neglect
• Estimated Study Start Date: April 1, 2019
• Estimated Primary Completion Date: November 1, 2019
• Estimated Study Completion Date: November 1, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Benjamin Rose Institute Care Consultation (BRI-CC)	Behavioral: 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).
No Intervention: No intervention

Outcome Measures

Primary Outcome Measures :

1. Feasibility as assessed by enrollment rate [ Time Frame: 6 months ]
   enrollment rate = # enrolled / # who met inclusion criteria
2. Feasibility as assessed by attrition rate [ Time Frame: 6 months ]

   attrition rate = # not completing the study

   / # enrolled at baseline

3. Feasibility as assessed by adherence rate [ Time Frame: 6 months ]
   adherence rate = # completing all BRI-CC sessions / # enrolled in intervention group
4. Feasibility as assessed by why subjects were not able to participate in BRI-CC [ Time Frame: 6 months ]
5. Feasibility as assessed by why subjects dropped out of BRI-CC [ Time Frame: 6 months ]

Secondary Outcome Measures :

1. Unmet needs of participants who receive home-delivered meals as assessed by domains of the Unmet Needs Instrument [ Time Frame: baseline ]
   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.
2. Unmet needs of of participants who receive home-delivered meals as assessed by domains of the Unmet Needs Instrument [ Time Frame: 3 months ]
   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.
3. Unmet needs of participants who receive home-delivered meals as assessed by domains of the Unmet Needs Instrument [ Time Frame: 6 months ]
   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.
4. Self Neglect as assessed by the Elder Self-Neglect Instrument (of participants who receive home-delivered meals) [ Time Frame: baseline ]

   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"?

5. Self Neglect as assessed by the Elder Self-Neglect Instrument (of participants who receive home-delivered meals) [ Time Frame: 6 months ]
   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"?
6. Number of participants who receive home-delivered meals who were admitted to the hospital [ Time Frame: 6 months ]
7. Number of participants who receive home-delivered meals who were readmitted to the hospital [ Time Frame: 6 months ]
8. Number participants who receive home-delivered meals who were relocated for long term care [ Time Frame: 6 months ]
9. Psychosocial well-being of the caregiver (CG) as assessed by the Zarit Burden Interview [ Time Frame: baseline ]
   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.
10. Psychosocial well-being of the informal caregiver as assessed by the Zarit Burden Interview [ Time Frame: 6 months ]
    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.
11. Caregiver depression as assessed by the Geriatric Depression Scale- Short Form [ Time Frame: baseline ]
    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
12. Caregiver depression as assessed by the Geriatric Depression Scale- Short Form [ Time Frame: 6 months ]
    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
13. Caregiver unmet needs as assessed by domains of the Unmet Needs Instrument [ Time Frame: baseline ]
    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.
14. Caregiver unmet needs as assessed by domains of the Unmet Needs Instrument [ Time Frame: 6 months ]
    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.
15. Emotional significance of pets to participants who receive home-delivered meals as assessed by the Monash Dog Owner Relationship Scale (MDORS) [ Time Frame: baseline ]
16. Unmet Pet Care needs of participants who receive home-delivered meals as assessed by the Unmet Pet Care Needs (UPCN) scale [ Time Frame: baseline ]

    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.

17. Barriers to pet caretaking as assessed by structured interviews over the telephone with participants who receive home-delivered meals [ Time Frame: baseline ]
18. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 60 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Contacts and Locations

Contacts

Contact: Sabrina L Pickens, PhD, RN, MSN; 713-500-2141; Sabrina.L.Pickens@uth.tmc.edu

Locations

United States, Texas

The University of Texas Health Science Center at Houston

Houston, Texas, United States, 77030

Contact: Sabrina L Pickens, PhD, RN, MSN 713-500-2141 Sabrina.L.Pickens@uth.tmc.edu

Sponsors and Collaborators

The University of Texas Health Science Center, Houston

Investigators

• Principal Investigator: Sabrina Pickens, PhD, RN, MSN; The University of Texas Health Science Center, Houston

More Information

• Responsible Party: Sabrina L Pickens, Assistant Professor, The University of Texas Health Science Center, Houston
• ClinicalTrials.gov Identifier: NCT03885063
• Other Study ID Numbers: HSC-SN-18-0741
• First Posted: March 21, 2019
• Last Update Posted: March 21, 2019
• Last Verified: March 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No