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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03885063
Other study ID # HSC-SN-18-0741
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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