Op technologie gebaseerde interventie-bruikbaarheid en piloottests (SIRENS)
Screening in de eerstelijnszorg en interventie voor zorgbeoordeling en ondersteuning voor patiënten met dementie: op technologie gebaseerde interventie-bruikbaarheid en piloottests
This research project has three main goals:
(1) To create a new screening tool that helps primary care doctors spot signs of neglect in older adults with dementia. (2) To design a support program that can be delivered both in person and through a mobile app on Android phones. (3) To run a clinical trial with three groups of participants to find out how effective the screening tool is on its own, and how effective it is when combined with the support program-compared to standard care.
This current phase of the project focuses on parts of goals 1 and 2, as described below.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
Elder abuse is common and has serious health consequences but is under-recognized and under-reported. Older adults with dementia are at much higher risk of mistreatment than other older adults, and the risk of mistreatment has been shown to be greater with increasing severity of dementia. This mistreatment is usually perpetrated by caregivers.
Screening for elder mistreatment and initiation of intervention in primary care clinics may be helpful, but few evidence-based tools or strategies exist. As few tools exist that may be effectively used in a busy clinical setting, evidence of the impact of screening and potential subsequent intervention on patient-important outcomes is lacking. Further, existing tools were developed for and studied in cognitively intact older adults and may not be appropriate for older adults with AD/ADRD.
In addition, elder mistreatment includes physical abuse, sexual abuse, verbal/emotional/psychological abuse, financial exploitation, and caregiver neglect. These different types of elder mistreatment represent very different phenomena, occur in various groups of older adults, and respond to very different intervention strategies. These discrepancies have made connecting positive identifications of mistreatment in the primary care setting to the next steps, including interventions, very challenging. Focusing on an intervention for caregiver neglect in older adults with dementia has the potential to address these challenges. Given that the severity of dementia represents a significant risk factor in the caregiving relationship, our goal is to provide support for dementia caregivers.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Chelsie Burchett, PhD
- Telefoonnummer: 6469627141
- E-mail: cob2014@med.cornell.edu
Studie Contact Back-up
- Naam: Sophie Park
- E-mail: sep4008@med.cornell.edu
Studie Locaties
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New York
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New York, New York, Verenigde Staten, 10065
- Werving
- Weill Cornell Medicine
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Contact:
- Chelsie Burchett, PhD
- Telefoonnummer: 646-962-7141
- E-mail: cob2014@med.cornell.edu
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Hoofdonderzoeker:
- Anthony Rosen, MD
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Caregiver Inclusion Criteria
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21 years old or older
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Provides care for a patient of Weill Cornell Medicine/NewYork-Presbyterian who meets the following criteria: (pilot only)
- Patient is at least 60 years old
- Patient has diagnosed dementia
- Patient requires assistance with at least 1 ADL
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Self-identifies as primary informal caregiver for an older adult
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Provides 8 or more hours per week of direct care (may include logistics, oversight, observation, as well as hands-on care, but must include at least some in-person assistance)
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Can read and speak English at a 6th grade level or above
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Not blind or deaf
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No active plan to disengage from providing care to the older adult within the next year
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Ability to travel to the COA or CABR for study activities and/or attend study session(s) virtually through Zoom on their personal device
Caregiver Exclusion Criteria
- Non-fluent English speaker
- Hired caregiver
- Provides care for a patient in hospice care
- Too ill or weak to complete the interviews (per the interviewer)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Experimental: SIRENS Intervention
The SIRENS intervention is a technology intervention designed specifically for caregivers of those with dementia, providing them with easy access to expert-reviewed information and helpful resources. The content includes take-home messages summarizing the main points discussed and a goal-setting feature that encourages the care givers to establish small, actionable goals. |
The SIRENS intervention is a technology intervention designed specifically for caregivers of those with dementia, providing them with easy access to expert-reviewed information and helpful resources. The content includes take-home messages summarizing the main points discussed and a goal-setting feature that encourages the care givers to establish small, actionable goals. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Perceived system feasibility, acceptability, and usability of the SIRENS intervention as measured by the Mean Difference in Score of the Program Evaluation Questionnaire.
Tijdsspanne: 1 week post-intervention
|
System feasibility, acceptability and usability will be assessed in the Program Evaluation Questionnaire. This is based on the Davis Perceived Usefulness, Perceived Ease of Use, and User Acceptance Scale. Response options range from 1= Strongly Disagree to 7= Strongly agree. Questions include those asking about the technology and components of the intervention. Total scores range from 23 to 161. Higher scores indicate greater user acceptance of the technology. |
1 week post-intervention
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Perceived system feasibility, acceptability, and usability of the SIRENS intervention as measured by a qualitative interview assessment
Tijdsspanne: 1-week post intervention
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System feasibility, acceptability and usability will be assessed in care partner participants using a semi-structured interview. Thematic analyses will be used to assess qualitative interviews. |
1-week post intervention
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Mean difference in score of caregiver burden, as measured by the Zarit Caregiver Burden Assessment.
Tijdsspanne: Baseline and 1 week post-intervention
|
Caregiver burden will be assessed in care partner participants using the reliable and valid Zarit Caregiver Burden Assessment. Response options range from 0= Never to 4= Nearly always. Questions include those asking about relationship with the care recipient and stress. Overall scores range from 0 to 48, with higher scores indicating more caregiver burden. |
Baseline and 1 week post-intervention
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Mean difference in score of caregiver quality of life, as measured by the Quality of Life Inventory
Tijdsspanne: Baseline and 1 week post-intervention
|
Caregiver quality of life will be assessed in care partner participants using the reliable and valid Quality of Life Inventory. Questions include those asking about importance (on a 3-point rating scale, higher value indicating more importance) and satisfaction (on a 6-point rating scale, higher value indicating more satisfaction) of life domains. Importance scores are multiplied by satisfaction scores for each domain, and then these scores are summed to determine the overall score. Overall scores range from -96 to 96, with higher scores indicating higher quality of life. |
Baseline and 1 week post-intervention
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Mean difference in score of caregiver preparedness, as measured by the Caregiver Preparedness Scale
Tijdsspanne: Baseline and 1 week post-intervention
|
Caregiver preparedness will be assessed in care partner participants using the Preparedness Scale. Response options range from 0= Not at all prepared to 4= Very well prepared. Overall scores range from 0 to 24 with higher scores indicating more feelings of preparedness. |
Baseline and 1 week post-intervention
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|
Mean difference in score of caregiving self-efficacy, as measured by the Caregiving Self-Efficacy Scale
Tijdsspanne: Baseline and 1 week post-intervention
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Caregiving self-efficacy will be measured in care partner participants by a modified Caregiving Self-Efficacy Scale. Response options range from 0= Can not do at all to 100= Certainly can do. Overall scores range from 0 to 900 with higher scores indicating more confidence. |
Baseline and 1 week post-intervention
|
|
Mean difference in score of caregiver depression, as measured by the Center for Epidemiologic Studies Depression Scale
Tijdsspanne: Baseline and 1 week post-intervention
|
Caregiver depression will be assessed in care partner participants using the reliable and valid Center for Epidemiologic Studies Depression Scale. Response options range from 0= Rarely or none of the time to 3= Most or almost none of the time. Overall scores range from 0 to 60 with higher scores indicating greater depressive symptoms. |
Baseline and 1 week post-intervention
|
Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Anthony Rosen, MD, Weill Cornell Medical College of Cornell University
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
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
- 24-05027492
- R61AG079012 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
The investigators plan for resource sharing is based on the National Institutes of Health/National Institute on Aging (NIH/NIA) Data Sharing Policy. The investigators plan, consistent with the NIH goals of data sharing, is to promote use of the rich SIRENS database by the larger research community as this will further the impact of SIRENS and expand possibilities for collaboration. It will also allow other researchers to expedite the translation of the research findings into knowledge, products, and procedures. Further, the plan is devised to make the data as widely and freely available as possible while at the same time safeguarding the privacy of participants and protecting confidential and proprietary data.
IPD-tijdsbestek voor delen
The data from research projects will be made available no later than acceptance of publication of the main findings from the final data set. There is no end date to access the data from the research projects.
IPD-toegangscriteria voor delen
The investigators agree to share the data with researchers working under an institution with Federal Wide Assurance who agree to a data sharing agreement that stipulates protection of participant privacy and data confidentiality, acknowledgement of SIRENS, that the data will be used for research purposes only, and that the data will not be transferred to other users. The computerized data will include raw data, derived variables, all necessary documentation as described in the National Archive of Computerized Data on Aging depositor agreement. All data will be de-identified. The investigators will follow the guides published by the US Department of Health and Human Services in this respect. Each data set will include data documentation to ensure that others can use the data set and to minimize confusion. Information about where and how to locate and access the data will be available in any publications and presentations authored by SIRENS investigators.
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- ICF
- ANALYTIC_CODE
- MVO
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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