18 and older, any sex, with Pathologic Processes. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Patients for Whom the Intervention Components Were FeasiblePrimary· 30 days after SNF discharge
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 complet
Transition Plan of Care
Group
Value
95% CI
Connect-Home Plus Patients
16
Care plan meeting
Group
Value
95% CI
Connect-Home Plus Patients
19
Advance directives
Group
Value
95% CI
Connect-Home Plus Patients
15
Follow-up medical appointments
Group
Value
95% CI
Connect-Home Plus Patients
16
Record transmission
Group
Value
95% CI
Connect-Home Plus Patients
19
Home visit within 24 hours
Group
Value
95% CI
Connect-Home Plus Patients
17
Call back #1 within 72 hours
Group
Value
95% CI
Connect-Home Plus Patients
17
Call back #2 and #3 within 30 days
Group
Value
95% CI
Connect-Home Plus Patients
16
Mean Patient Intervention Satisfaction ScoresPrimary· 21 days after SNF discharge
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
Helpfulness
Group
Value
95% CI
Connect-Home Plus Patients
1.0
± 0
Usefulness
Group
Value
95% CI
Connect-Home Plus Patients
1.0
± 0
Appropriateness
Group
Value
95% CI
Connect-Home Plus Patients
1.0
± 0
Mean Caregiver Intervention Satisfaction ScoresPrimary· 21 days after SNF discharge
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) ho
Helpfulness
Group
Value
95% CI
Connect-Home Plus Caregivers
1.3
± 0.5
Usefulness
Group
Value
95% CI
Connect-Home Plus Caregivers
1.0
± 0
Appropriateness
Group
Value
95% CI
Connect-Home Plus Caregivers
1.3
± 0.5
Care Transitions Measure-15 (Patient)Secondary· 7 Days After SNF Discharge
The patient's preparedness for discharge will be measured by the Care Transitions Measure-15 (CTM-15), which includes 15 items on a 4-point scale. The CTM-15 measures self-reported knowledge and skills for continuing care at home. Summary scores range 0-100, with higher scores indicating greater preparedness. Data collected from either the Patient or the Caregiver serving as proxy.
Group
Value
95% CI
Connect-Home Plus Patients
70.3
± 12.0
Preparedness for Caregiving Scale (Caregiver)Secondary· 7 Days After SNF Discharge
The caregiver's preparedness for caregiving will be measured by the Preparedness for Caregiving Scale (PCS), which includes 8 items on a five-point Likert scale (0-4). The PCS measures self-reported readiness for caregiving. Range = 0-32, with higher scores associated with greater preparedness.
Group
Value
95% CI
Connect-Home Plus Caregivers
24.8
± 12.4
Life Space AssessmentSecondary· 30 Days After SNF Discharge
Patient's function will be measured using the Life Space Assessment, which includes 5 Likert scales corresponding to a hierarchy of levels of mobility (each scored from 0-4) where weights are the product of the "Life-space level" (range 1-5) and the"independence" score (range 1-2). The range is 1-120. Lower scores are associated with less life-space.
Group
Value
95% CI
Connect-Home Plus Patients
20.1
± 9.6
Dementia Quality of Life Measure (Patient)Secondary· 30 Days After SNF Discharge
The quality of life of the person with ADRD will be assessed with the Dementia Quality of Life Measure. It has 28 items that cover four quality of life dimensions: daily activities, memory, negative emotion and positive emotion. The score range is 28-112 with higher scores indicating better quality of life.
Group
Value
95% CI
Connect-Home Plus Patients
90.8
± 9.9
Dementia Quality of Life-Proxy Measure (Caregiver)Secondary· 30 Days After SNF Discharge
When the Patient was unable to answer the DEMQOL, the Caregiver was surveyed with the DEMQOL-Proxy. With this measure, the score range is 31-124 with higher scores indicating better quality of life.
Group
Value
95% CI
Connect-Home Plus Caregivers
91.1
± 10.3
Mean Self-Reported Days of ED or Hospital Use 30 Days After Skilled Nursing Facility Discharge (Patient)Secondary· 30 Days After SNF Discharge
Patient's days of acute care use will be measured using the self-reported number of combined number of days the patients pends in the Emergency Department (ED) or hospital in 30 days after SNF discharge.
Group
Value
95% CI
Connect-Home Plus Patients
0.58
± 1.7
Zarit Caregiver Burden Scale (Caregiver)Secondary· 30 Days After SNF Discharge
Caregiver burden will be measured using the Zarit Caregiver Burden Scale, which includes 12 items on a five-point scale,measuring caregiver perceptions that "caregiving has an adverse effect on their emotional, social, financial, physical and spiritual functioning." Scores range 0-48; higher scores are associated with greater burden.
Group
Value
95% CI
Connect-Home Plus Caregivers
16.6
± 6.6
Distress Thermometer (Caregiver)Secondary· 30 Days After SNF Discharge
Caregiver distress will be measured using the Distress Thermometer, which includes 1 item on an 11-point scale, measuring negative affect (e.g., sadness and fear) related to caregiving for a severely ill person. Score ranges 0-10, with scores \>4 associated with distress.
Group
Value
95% CI
Connect-Home Plus Caregivers
4.1
± 3.1
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 60 days..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by University of North Carolina, Chapel Hill
Last refreshed: 21 July 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05887388.