Persoon-omgeving geschikt voor personen met dementie
Verbetering van de fit tussen persoon en omgeving van thuiswonende ouderen met dementie
This trial will assess feasibility of a non-pharmacological intervention for persons living with Alzheimer's disease and related dementias (ADRD) to improve behavioral and psychiatric symptoms of dementia and functional performance.
Using a two-arm, prospective randomized controlled trial, 38 dyads (person with ADRD and caregiver) will complete an 8-week telehealth occupational therapy intervention provided via Zoom with caregivers and persons with dementia or receive an active control with 8 telehealth sessions to discuss publicly available caregiver education with a non-clinical research assistant.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
Kentucky
-
Lexington, Kentucky, Verenigde Staten, 40536
- University of Kentucky
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria: Participants with Dementia
- Men or women aged 60-99, inclusive.
- Living at home in the community with one primary caregiver.
- Diagnosis or probably diagnosis of dementia (confirmed by Clinical Dementia Rating Scale score of 1.0+)
- If on psychotropic medication, they are at a point where dosage and treatment are stabilized for the duration of the study.
- Functional sensory abilities with or without aids (hearing, vision, smell, touch, taste)
- Caregiver report of challenges related to behaviors within 4 weeks of study enrollment.
- Caregiver willing to participate throughout duration of study.
- Contact with University of Kentucky Alzheimer's Disease Research Center or Kentucky Neuroscience Institute medical provider within 12 months of study recruitment.
Inclusion Criteria: Caregiver for Participants with Dementia
- Men or women aged 21-99, inclusive.
- Willingness to participate in study and implement recommended data collection tools.
- English speaking, able to read and write.
- Ability to retrieve and send mail.
Exclusion Criteria: Participants with Dementia
- Unstable medical conditions within one month prior to screening visit such as poorly controlled blood pressure, diabetes, current cancer diagnosis, or breathing problems, etc.
- Wheelchair or bed bound.
- Residence in skilled nursing facility or facility-based care.
- Caregiver report of physically violent behaviors.
- Initiation of antipsychotic medication within 4 weeks prior to screening or unpredictable use of such medications
- Diagnosis of profound or total sensory altering disorders including macular degeneration, legal blindness, total deafness, severe peripheral neuropathy, anosmia.
- Major depression in past 12 months (DSM-IV criteria), major mental illness such as schizophrenia, bipolar disorder, personality disorders, or recent (in past 12 months) alcohol or substance abuse.
- Major infection within 4 weeks prior to the Baseline Visit.
Exclusion Criteria: Caregiver for Participant with Dementia:
• Diagnosis of mild cognitive impairment or dementia.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Harmony
Participants in this group will receive the Harmony intervention. |
The Harmony intervention builds on prior successful foundations of dementia care interventions with a novel approach combining remote implementation, antecedent education, and home environment intervention. The intervention will teach caregivers how to 1) assess the home environment as an antecedent to behavior for the person with ADRD, and 2) design and implement individualized environmental modification through an environmental cueing approach to address the needs of the person with ADRD in a supportive environment. |
|
Actieve vergelijker: National Institute on Aging Program
Participants in this group will receive the National Institute on Aging education. |
Standard of care will address behaviors and psychiatric symptoms of dementia (BPSD) for persons with ADRD, as recommended by their medical provider. Caregivers will receive training regarding home safety via a home safety handout based on National Institutes on Aging "Home Safety and Alzheimer's Disease" webpage. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Patient Performance as Measured by Canadian Occupational Performance Measure (COPM)
Tijdsspanne: Baseline to 13 Week Follow-Up
|
Criterion-referenced interview of patient performance with caregiver The COPM is a reliable and validated measure of performance in primary daily activities (self-care, leisure, productivity) with dyad-caregiver rated of performance and satisfaction. Scores are determined on a likert scale of 1-10 with 1 being lowest and 10 indicating highest of the topic of the question. |
Baseline to 13 Week Follow-Up
|
|
Caregiver Satisfaction of Patient Performance [Feasibility]
Tijdsspanne: Baseline to 13 Week Follow-Up
|
The primary outcome analysis is the feasibility of implementation as measured by caregiver satisfaction. The Canadian Occupational Performance Measure will measure caregiver satisfaction of patient performance, high scores indicate higher levels of satisfaction. Range 0-10. |
Baseline to 13 Week Follow-Up
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Zarit Caregiver Burden Scale
Tijdsspanne: Baseline to 13 Week Follow-Up
|
22-item survey, caregiver rates self-perceived level of burden on 5-point Likert scale. The social context of the person with ADRD will be described through analysis of caregiver demographics and rate of caregiver burden measured. Higher scores indicate greater burden. Range of 0-88 points. A score of 17 or more was considered high burden. |
Baseline to 13 Week Follow-Up
|
|
Neuropsychiatric Inventory Questionnaire (NPI-Q)
Tijdsspanne: Baseline to 13 Week Follow-Up
|
The NPI-Q is commonly used as an assessment of behavioral and psychiatric symptoms of dementia in older adults diagnosed with mild cognitive impairment or dementia, internationally, with high reliability and validity. Assessment includes 12 behavioral and psychiatric domains which are rated by caregiver as present or absent (yes/no). Caregivers further rate severity of present behavioral domains. The severity score is summed to yield a total as a measure of BPSD burden. Higher scores indicate higher levels of behavior symptom severity and/or distress. Range 0-36 |
Baseline to 13 Week Follow-Up
|
|
Functional Behavior Profile (FBP)
Tijdsspanne: Baseline to 13 Week Follow-Up
|
Criterion-referenced survey completed by caregiver. The FBP has been established as a reliable and valid measure of task performance, social interaction, and problem solving with adults with ADRD. The FBP consists of 27 items rated from 0 to 4, with higher scores indicating better performance. The total score ranges from 0 to 108. The FBP includes three subscales: Task Performance (0-36), Social Interaction (0-24) and Problem Solving (0-48). Subscale scores are summed to calculate the total FBP score. |
Baseline to 13 Week Follow-Up
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Elizabeth Rhodus, PhD, University of Kentucky
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 72893
- 1K23AG075262-01A1 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .