A Family-centered Intervention for Acutely-ill Persons With Dementia
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|ClinicalTrials.gov Identifier: NCT03046121|
Recruitment Status : Active, not recruiting
First Posted : February 8, 2017
Last Update Posted : April 26, 2022
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease||Behavioral: Family-centered Function-focused Care (Fam-FFC)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||461 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Reducing Disability Via a Family-centered Intervention for Acutely-ill Persons With Alzheimer's Disease and Related Dementias|
|Actual Study Start Date :||November 6, 2017|
|Actual Primary Completion Date :||February 28, 2022|
|Estimated Study Completion Date :||July 31, 2022|
The intervention consists of :Component 1- Environmental and Policy Assessments; Component II- Education of Nursing Staff; Component III-Ongoing Training/Motivation of Nursing Staff. The Fam-FFC Nurse will work with the champions to mentor and motivate nursing staff to provide: (a) role modeling Fam-FFC, reinforcing performance of Fam-FFC, and brainstorming about ways to overcome challenges; (b) highlighting staff role models; Component IV Implementation of the FamPath Pathway which includes: (a) information on the admitting condition, diagnostics, treatment;(b) family/patient education; (c) transitional hand-off to post-acute providers; and (d) post-acute follow-up to provide ongoing education and modification of the function-focused care plan.
Behavioral: Family-centered Function-focused Care (Fam-FFC)
An educational empowerment model for family CGs that includes a care pathway, provided within a social-ecological in-patient framework promoting specialized care to patients with ADRD. The intervention creates an "enabling" milieu for the person with ADRD through environmental and policy assessment/modification, staff education, unit-based champions, and individualized goal setting that focuses on functional recovery during hospitalization and the immediate post-acute period.
No Intervention: Attention Control (Fam- FFC Ed-only)
Education of the nursing staff in participating hospital units (exactly as offered in treatment sites), and education of family caregivers about hospital orientation and reinforcement of discharge teaching (medications/treatments, medical follow-up).
- physical function [ Time Frame: 6 months post-discharge ]activities of daily living (Barthel Index)
- functional performance [ Time Frame: 6 months post-discharge ]Timed Chair Rise
- Physical activity [ Time Frame: 6 months post-discharge ]actigraphy recording activity in set epochs of time
- Delirium occurrence [ Time Frame: 6 months post-discharge ]any episode of delirium evaluated by the MoCA observation and the Confusion Assessment Method (CAM).
- Delirium severity [ Time Frame: 6 months post-discharge ]Degree of delirium evaluated with an additive score for six items of the Confusion Assessment Method
- Behavior [ Time Frame: 6 months post-discharge ]evidence of neuropsychiatric symptoms (Brief Neuropsychiatric Inventory)
- Mood [ Time Frame: 6 months post-discharge ]evidence of depression (Cornell Scale)
- Preparedness for caregiving [ Time Frame: 6 months post-discharge ]how well prepared family caregivers believe they are for multiple domains of caregiving (Preparedness for Caregiving Scale)
- Caregiver Strain [ Time Frame: 6 months post-discharge ]measures strain (financial, physical, social, psychological, and personal) related to care provision (Modified Caregiver Strain Index)
- Caregiver Burden [ Time Frame: 6 months post-discharge ]caregiver perception of burden (Zarit Burden Interview)
- Desire to Institutionalize [ Time Frame: 6 months post-discharge ]6-item scale measuring caregiver desire to transfer the patient to a nursing home (Desire to Institutionalize Scale)
- health care cost [ Time Frame: end of intervention at each study site, 12 months after enrollment initiated ]staff and research nurse time and hours worked, training time (including replacement), supplies, and incentives
- post-acute health care utilization [ Time Frame: six months after discharge ]cumulative count of emergency room visits, number/days of hospitalizations, and long-term nursing home admissions
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): NCT03046121
|United States, Pennsylvania|
|Hospital of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|