Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03885063
Recruitment Status : Not yet recruiting
First Posted : March 21, 2019
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Sabrina L Pickens, The University of Texas Health Science Center, Houston

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

Layout table for study information
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

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



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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885063


Contacts
Layout table for location contacts
Contact: Sabrina L Pickens, PhD, RN, MSN 713-500-2141 Sabrina.L.Pickens@uth.tmc.edu

Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Sabrina Pickens, PhD, RN, MSN The University of Texas Health Science Center, Houston
Layout table for additonal 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    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No