NCT05887388|CompletedResultsDMC
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Sponsor study identifier
Secondary identifiers
interventional
38
1 country
1
Study Start
September 10, 2021
Actual (reported)Primary Completion
February 27, 2022
Actual (reported)Study Completion
March 18, 2022
Actual (reported)This primary purpose of this study will be to (1) examine the feasibility and acceptability of transitional care focusing on care needs of skilled nursing facility (SNF) patients with dementia and their caregivers (primary aim). The secondary purpose will be to describe the effect of the intervention on SNF patient outcomes (preparedness for discharge, quality of life, function and acute care use) and caregiver outcomes (preparedness for the caregiving role, caregiver burden and caregiver distress).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 18, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 10, 2021
Actual (reported)February 27, 2022
Actual (reported)March 18, 2022
Actual (reported)May 24, 2023
Actual (reported)June 2, 2023
Actual (reported)July 21, 2023
Actual (reported)Number of Patients for Whom the Intervention Components Were Feasible
Feasibility will measured using an instrument to audit skilled nursing facility medical records of the patient and the intervention log of services for the Patient and Caregiver dyad. It includes eight dichotomous (yes-no) items that indicate feasibility of the Connect-Home Plus intervention. The feasibility items include: (1) completing the Transition Plan of Care; (2) convening the care plan meeting with caregiver attending; (3) reviewing advance directives in the SNF; (4) scheduling follow-up medical appointments; (5) transmitting records to follow-up clinicians; (6) home care nurse completion of the first home visit within 24 hours after discharge; (7) completion of first caregiver support call within 72 hours of discharge; (8) completion of the second and third caregiver support call within one month of discharge. A "Yes" answer indicates that the intervention component was feasible to provide for the patient and caregiver dyad.
30 days after SNF discharge
Mean Patient Intervention Satisfaction Scores
This interview guide will be used to assess the acceptability of Connect-Home Plus with persons with ADRD. The interview will include questions about (1) factors that made the Connect-Home Plus transitional care services easy or difficult to use, (2) specific supports that were and were not helpful, (3) the effect of Connect-Home Plus on how to manage issues related to ADRD at home, and (4) unmet needs for care of issues related to ADRD at home. Responses to the interview guide questions will be used to generate 3 4-point Likert scale acceptability scores, including (1) how helpful was Connect-Home Plus, (2) how difficult were these services to use, and (3) how well did these services prepare you for care at home. The scores will include 0 meaning not applicable, and scores 1-3 indicating acceptability, with lower scores indicating higher acceptability.
21 days after SNF discharge
Mean Caregiver Intervention Satisfaction Scores
Care Transitions Measure-15 (Patient)
7 Days After SNF Discharge
Preparedness for Caregiving Scale (Caregiver)
7 Days After SNF Discharge
Life Space Assessment
30 Days After SNF Discharge
Dementia Quality of Life Measure (Patient)
30 Days After SNF Discharge
Dementia Quality of Life-Proxy Measure (Caregiver)
30 Days After SNF Discharge
Connect-Home Plus will be delivered in the skilled nursing facility and via telephone after discharge.
Connect-Home Plus will introduce organizational structure to support delivery of transitional care processes. New elements of structure include:electronic health record (EHR) template, Connect-Home Plus Toolkit, and Staff Training. After structural elements are added, SNF staff will use Connect-Home Plus care processes to deliver the 2-step transitional care intervention.In Step 1, SNF nurses,therapists, and social workers will develop a Transition Plan of Care and prepare the patient and caregiver to manage the illness and functional needs. In Step 2, a dementia caregiving specialist will call the patient's home three times within 30 days of discharge. Both intervention steps will focus on key care needs, such as 1) home safety; 2) care of symptoms of ADRD; 3) symptom management; 4) medication reconciliation; 5) function and activity; and 6) coordination of follow-up medical care.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
UNC-Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Mark Toles, MPH
University of North Carolina, Chapel Hill
38 participants (actual enrollment reported by the registry).
First Submitted
May 24, 2023
First Posted
June 2, 2023
Study Start
September 10, 2021
Actual (reported)Pilot Study to Identify the Influence of Genetic Profile Aberrations on Patients With Recurrent Hernias
This interview guide will be used to assess the acceptability of Connect-Home Plus with caregivers of persons with ADRD. This interview guide will include questions about (1) factors that made the Connect-Home Plus transitional care services easy or difficult to use, (2) specific supports that were and were not helpful, (3) the effect of Connect-Home Plus on how to manage issues related to ADRD at home, and (4) unmet needs for care of issues related to ADRD at home. Responses to the interview guide questions will be used to generate 3 4-point Likert scale acceptability scores, including (1) how helpful was Connect-Home Plus, (2) how difficult were these services to use, and (3) how well did these services prepare you for care at home. The scores will include 0 meaning not applicable, and scores 1-3 indicating acceptability, with lower scores indicating higher acceptability
21 days after SNF discharge
Contact the study team to confirm eligibility.
Primary Completion
February 27, 2022
Actual (reported)Study Completion
March 18, 2022
Actual (reported)Last Updated
July 21, 2023
Results First Posted
July 21, 2023
Record last verified: 2023-06
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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