- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05887388
Adapting Connect-Home Transitional Care for the Unique Needs of Persons With Alzheimer's Disease and Other Dementias and Their Caregivers
Adapting Connect-Home Transitional Care to Fit the Unique Needs of Persons With Alzheimer's Disease and Other Dementias and Their Caregivers: A Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Persons with Alzheimer's disease and related dementia (ADRD) and their caregivers confront complex health challenges during transfers from skilled nursing facilities (SNF) to home, such as recent acute illness and functional losses, incurable medical conditions, patient dependence on family caregivers, and sequelae of declining cognitive ability, such as agitated or aggressive behavior and depression. Other research indicates that usual discharge planning does not address the unique care needs of SNF patients with ADRD and caregiver dyads as they prepare for SNF discharge and begin home-based care. Building on our previous studies and observational studies of unmet care needs of SNF patients with ADRD and their caregivers, the investigators developed Connect-Home Plus, a transitional care intervention to prepare dyads for SNF discharge and caregiver support at home after SNF discharge.
Connect-Home Plus will provide new versions of the Connect-Home transitional plan of care EHR template, toolkit, and staff training protocol. The adapted version will support staff in tailoring the transitional care processes to fit the needs of persons with ADRD and their caregivers. It will include (1) new tools to move staff stepwise through a process to prepare persons with AD/ADRD for discharge, and (2) staff training to increase the ability of staff to tailor transitional care plans for the unique needs of persons with ADRD and their caregivers.
The investigators will use a single-arm post-test-only trial design with a sample of 20 persons with ADRD and 20 caregivers in 2 SNFs over 6 months. The investigators will determine the feasibility and acceptability of Connect-Home Plus and estimated mean outcomes of persons with ADRD and their caregivers. Feasibility will be assessed with a chart review of SNF medical records. Acceptability will be assessed with questionnaire with patients and caregivers in 21 days after patient discharge from the SNF to home. Patient and caregiver outcomes will be assessed with questionnaires in 30 days after patient discharge from the SNF to home. Data will be analyzed using descriptive statistics.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- UNC-Chapel Hill
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Patient Inclusion Criteria:
- be able to speak English
- have a goal of discharge to home
- have a diagnosis of ADRD, or a Brief Inventory of Mental Status (BIMS) score <13, or (for persons unable to complete the BIMS assessment), have a Cognitive performance score of ≥3 (calculated using data in the Minimum Data Set 3.0 and an algorithm for estimating cognitive impairment using Minimum Data Set 3.0 data other than BIMS)
- have a caregiver willing to participate.
- for patients with documentation in the medical record of a caregiver who is the patient's legally authorized representative, consent of the caregiver to participate in the study as the patient's representative.
Patient Exclusion Criteria:
- unable to speak English
Caregiver Inclusion Criteria
- self-reports assisting the patient at home
- the ability to speak English.
Caregiver Exclusion Criteria
- unable to speak English
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Connect-Home Plus will be delivered in the skilled nursing facility and via telephone after discharge.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients for Whom the Intervention Components Were Feasible
Time Frame: 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 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.
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30 days after SNF discharge
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Mean Patient Intervention Satisfaction Scores
Time Frame: 21 days after SNF discharge
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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.
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21 days after SNF discharge
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Mean Caregiver Intervention Satisfaction Scores
Time Frame: 21 days after SNF discharge
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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
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21 days after SNF discharge
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Care Transitions Measure-15 (Patient)
Time Frame: 7 Days After SNF Discharge
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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.
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7 Days After SNF Discharge
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Preparedness for Caregiving Scale (Caregiver)
Time Frame: 7 Days After SNF Discharge
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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.
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7 Days After SNF Discharge
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Life Space Assessment
Time Frame: 30 Days After SNF Discharge
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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.
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30 Days After SNF Discharge
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Dementia Quality of Life Measure (Patient)
Time Frame: 30 Days After SNF Discharge
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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.
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30 Days After SNF Discharge
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Dementia Quality of Life-Proxy Measure (Caregiver)
Time Frame: 30 Days After SNF Discharge
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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.
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30 Days After SNF Discharge
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Mean Self-Reported Days of ED or Hospital Use 30 Days After Skilled Nursing Facility Discharge (Patient)
Time Frame: 30 Days After SNF Discharge
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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.
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30 Days After SNF Discharge
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Zarit Caregiver Burden Scale (Caregiver)
Time Frame: 30 Days After SNF Discharge
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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.
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30 Days After SNF Discharge
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Distress Thermometer (Caregiver)
Time Frame: 30 Days After SNF Discharge
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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.
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30 Days After SNF Discharge
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Mark Toles, MPH, University of North Carolina, Chapel Hill
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-2406
- R01NR017636-03 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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