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

Self Neglect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03885063
• Other study ID #: HSC-SN-18-0741
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: November 1, 2019

Study information

• Verified date: March 2019
• Source: The University of Texas Health Science Center, Houston
• Contact: Sabrina L Pickens, PhD, RN, MSN
• Phone: 713-500-2141
• Email: Sabrina.L.Pickens[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: November 1, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Self Neglect

Intervention

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).

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility as assessed by enrollment rate	enrollment rate = # enrolled / # who met inclusion criteria	6 months
Primary	Feasibility as assessed by attrition rate	attrition rate = # not completing the study; / # enrolled at baseline	6 months
Primary	Feasibility as assessed by adherence rate	adherence rate = # completing all BRI-CC sessions / # enrolled in intervention group	6 months
Primary	Feasibility as assessed by why subjects were not able to participate in BRI-CC		6 months
Primary	Feasibility as assessed by why subjects dropped out of BRI-CC		6 months
Secondary	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.	baseline
Secondary	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.	3 months
Secondary	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.	6 months
Secondary	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"?	baseline
Secondary	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"?	6 months
Secondary	Number of participants who receive home-delivered meals who were admitted to the hospital		6 months
Secondary	Number of participants who receive home-delivered meals who were readmitted to the hospital		6 months
Secondary	Number participants who receive home-delivered meals who were relocated for long term care		6 months
Secondary	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.	baseline
Secondary	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.	6 months
Secondary	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	baseline
Secondary	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	6 months
Secondary	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.	baseline
Secondary	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.	6 months
Secondary	Emotional significance of pets to participants who receive home-delivered meals as assessed by the Monash Dog Owner Relationship Scale (MDORS)		baseline
Secondary	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.	baseline
Secondary	Barriers to pet caretaking as assessed by structured interviews over the telephone with participants who receive home-delivered meals		baseline
Secondary	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		baseline