Technology-Based Intervention Pilot Testing
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorWeill Medical College of Cornell University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Provides care for a patient of Weill Cornell Medicine/NewYork-Presbyterian who meets the following criteria: (pilot only)
Patient is at least 65 years old
Patient has diagnosed dementia
Patient requires assistance with at least 1 ADL
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
SIRENS
BehavioralThe 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Experimental: SIRENS InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Perceived system feasibility, acceptability, and usability of the SIRENS intervention as measured by the Mean Difference in Score of the Program Evaluation Questionnaire.
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.
Time frame
1 week post-intervention2
Perceived system feasibility, acceptability, and usability of the SIRENS intervention as measured by a qualitative interview assessment
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.
Time frame
1-week post interventionSecondary outcomes
1
Mean difference in score of caregiver burden, as measured by the Zarit Caregiver Burden Assessment.
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.
Time frame
Baseline and 1 week post-intervention2
Mean difference in score of caregiver quality of life, as measured by the Quality of Life Inventory
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.
Time frame
Baseline and 1 week post-intervention3
Mean difference in score of caregiver preparedness, as measured by the Caregiver Preparedness Scale
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.
Time frame
Baseline and 1 week post-intervention4
Mean difference in score of caregiving self-efficacy, as measured by the Caregiving Self-Efficacy Scale
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.
Time frame
Baseline and 1 week post-interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Weill Medical College of Cornell University
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov
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