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

NCT03885063 | Terminated

• 1 other identifier: HSC-SN-18-0741
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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).

Conditions

Self Neglect

Outcome Measures

Primary Outcomes (5)

• Feasibility as assessed by enrollment rate

  enrollment rate = # enrolled / # who met inclusion criteria

  6 months

• Feasibility as assessed by attrition rate

  attrition rate = # not completing the study / # enrolled at baseline

  6 months

• Feasibility as assessed by adherence rate

  adherence rate = # completing all BRI-CC sessions / # enrolled in intervention group

  6 months

• Feasibility as assessed by why subjects were not able to participate in BRI-CC

  6 months

• Feasibility as assessed by why subjects dropped out of BRI-CC

  6 months

Secondary Outcomes (18)

• Unmet needs of participants who receive home-delivered meals as assessed by domains of the Unmet Needs Instrument

  baseline

• Unmet needs of of participants who receive home-delivered meals as assessed by domains of the Unmet Needs Instrument

  3 months

• Unmet needs of participants who receive home-delivered meals as assessed by domains of the Unmet Needs Instrument

  6 months

• Self Neglect as assessed by the Elder Self-Neglect Instrument (of participants who receive home-delivered meals)

  baseline

• Self Neglect as assessed by the Elder Self-Neglect Instrument (of participants who receive home-delivered meals)

  6 months

Study Arms (2)

Benjamin Rose Institute Care Consultation (BRI-CC)

EXPERIMENTAL

Behavioral: Benjamin Rose Institute Care Consultation (BRI-CC)

No intervention

NO INTERVENTION

Interventions

Benjamin Rose Institute Care Consultation (BRI-CC) BEHAVIORAL

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).

Benjamin Rose Institute Care Consultation (BRI-CC)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Study Officials

• Sabrina Pickens, PhD, RN, MSN

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: March 21, 2019
• Study Start: April 1, 2019
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)