Clinical trial NCT03885063: Modifying a Telephone Based Care Program to Assess for Self-Neglect
Official title: Modifying a Telephone Based Care Program to Assess for Self-Neglect
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Self Neglect
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2019-03-21
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).


Eligibility 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

Primary outcomes:
measure: Feasibility as assessed by enrollment rate
timeFrame: 6 months
measure: Feasibility as assessed by attrition rate
timeFrame: 6 months
measure: Feasibility as assessed by adherence rate
timeFrame: 6 months
measure: Feasibility as assessed by why subjects were not able to participate in BRI-CC
timeFrame: 6 months
measure: Feasibility as assessed by why subjects dropped out of BRI-CC
timeFrame: 6 months
Secondary outcomes:
measure: Unmet needs of participants who receive home-delivered meals as assessed by domains of the Unmet Needs Instrument
timeFrame: baseline
measure: Unmet needs of of participants who receive home-delivered meals as assessed by domains of the Unmet Needs Instrument
timeFrame: 3 months
measure: Unmet needs of participants who receive home-delivered meals as assessed by domains of the Unmet Needs Instrument
timeFrame: 6 months
measure: Self Neglect as assessed by the Elder Self-Neglect Instrument (of participants who receive home-delivered meals)
timeFrame: baseline
measure: Self Neglect as assessed by the Elder Self-Neglect Instrument (of participants who receive home-delivered meals)
timeFrame: 6 months
measure: Number of participants who receive home-delivered meals who were admitted to the hospital
timeFrame: 6 months
measure: Number of participants who receive home-delivered meals who were readmitted to the hospital
timeFrame: 6 months
measure: Number participants who receive home-delivered meals who were relocated for long term care
timeFrame: 6 months
measure: Psychosocial well-being of the caregiver (CG) as assessed by the Zarit Burden Interview
timeFrame: baseline
measure: Psychosocial well-being of the informal caregiver as assessed by the Zarit Burden Interview
timeFrame: 6 months
measure: Caregiver depression as assessed by the Geriatric Depression Scale- Short Form
timeFrame: baseline
measure: Caregiver depression as assessed by the Geriatric Depression Scale- Short Form
timeFrame: 6 months
measure: Caregiver unmet needs as assessed by domains of the Unmet Needs Instrument
timeFrame: baseline
measure: Caregiver unmet needs as assessed by domains of the Unmet Needs Instrument
timeFrame: 6 months
measure: Emotional significance of pets to participants who receive home-delivered meals as assessed by the Monash Dog Owner Relationship Scale (MDORS)
timeFrame: baseline
measure: Unmet Pet Care needs of participants who receive home-delivered meals as assessed by the Unmet Pet Care Needs (UPCN) scale
timeFrame: baseline
measure: Barriers to pet caretaking as assessed by structured interviews over the telephone with participants who receive home-delivered meals
timeFrame: baseline
measure: 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
timeFrame: baseline
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Sabrina Pickens, PhD, RN, MSN
role: PRINCIPAL_INVESTIGATOR
References: