Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06425510
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-05-17
Brief Title:
Using Technology to Improve Function for Older Latinos With Disabilities in Underserved Areas
Sponsor:
University of Puerto Rico
Organization:
University of Puerto Rico
Study Overview
Official Title:
Tech Enabled Functional Health Bridging Primary Care Gaps for Older Latinos With Functional Disabilities in Underserved Communities
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This project aims to test a culturally appropriate assistive technology AT intervention called VIVE-AT to help older Latinos with disabilities improve their function and quality of life The researchers will first refine the VIVE-AT program based on feedback from a Community Advisory Board and focus groups with older Latinos with disabilities Then 76 older Latinos with disabilities will be recruited from a primary care clinic serving low-income communities in Puerto Rico They will be randomly assigned to either receive the VIVE-AT intervention in the primary care clinic or be placed on a waitlist with regular phone calls All participants will continue to receive standard care at the clinic
Detailed Description:
Functional disabilities FDs defined as difficulties in performing daily activities constitute a significant public health problem associated with increased dependency poor health outcomes diminished quality of life institutionalization and premature death Older Latinos residing in Puerto Rico PR are disproportionately affected by FDs with one of the highest rates of FDs 58 in the US and its territories Research has demonstrated positive outcomes from employing assistive technology AT devices such as jar openers sock aids and canes among older adults with FDs thereby enhancing their functioning participation and capacity to remain at home or in the community for a longer period However Latinos are among the least likely to utilize AT Given the dearth of culturally competent assistive technology interventions for Latinos along with the scarcity of rehabilitation professionals and assistive technology services in primary healthcare facilities this project leverages preliminary data from a prior study that assessed the feasibility of the Viviendo las Ventajas de la Asistencia Tecnológica VIVE-AT for short Living the Advantages of Assistive Technologies intervention The specific aims of this project are to
1 refine the protocol of the VIVE-AT to align with the unique needs of the primary health care clinic
2 assess the efficacy of the VIVE-AT in comparison to a waitlist control arm in decreasing FDs and improving the quality of life among Latinos aged 65 years post-intervention and at six months
3 evaluate whether proposed mechanisms of change in FDs specifically knowledge of AT motivation for using AT self-efficacy for using AT and use of AT account for the reduction in FDs post-intervention
To achieve these aims the interdisciplinary team of this project will first refine the intervention based on recommendations from participants in the feasibility study as well as input from the Community Advisory Board and older Latinos with FDs through iterative focus groups Aim 1 Subsequently 76 older Latinos with physical FDs recruited from a primary health care facility serving low-income communities in PR will be randomly assigned to either the VIVE-AT intervention group n38 or a waitlist attention calls controlled condition group n38 to assess its efficacy and mechanisms of change Aims 2 and 3 All participants will receive standard usual care at the primary health care center Participants in the intervention group will attend a weekly two-hour group session for 6 weeks facilitated by trained healthcare workers focusing on self-management of FDs through the use of AT Additionally participants will receive up to five AT devices tailored to their specific FI needs along with training on their usage All participants will be assessed at baseline post-intervention and six months after intervention The goals of the VIVE-AT are to encourage participants to use AT devices to self-manage their FDs and improve their quality of life Our approach will contribute to scientific knowledge and inform a subsequent scalable multisite Hybrid Type I RCT designed to evaluate its effectiveness in reducing physical FDs among older Latinos in primary healthcare settings in the US and PR
1 refine the protocol of the VIVE-AT to align with the unique needs of the primary health care clinic
2 assess the efficacy of the VIVE-AT in comparison to a waitlist control arm in decreasing FDs and improving the quality of life among Latinos aged 65 years post-intervention and at six months
3 evaluate whether proposed mechanisms of change in FDs specifically knowledge of AT motivation for using AT self-efficacy for using AT and use of AT account for the reduction in FDs post-intervention
To achieve these aims the interdisciplinary team of this project will first refine the intervention based on recommendations from participants in the feasibility study as well as input from the Community Advisory Board and older Latinos with FDs through iterative focus groups Aim 1 Subsequently 76 older Latinos with physical FDs recruited from a primary health care facility serving low-income communities in PR will be randomly assigned to either the VIVE-AT intervention group n38 or a waitlist attention calls controlled condition group n38 to assess its efficacy and mechanisms of change Aims 2 and 3 All participants will receive standard usual care at the primary health care center Participants in the intervention group will attend a weekly two-hour group session for 6 weeks facilitated by trained healthcare workers focusing on self-management of FDs through the use of AT Additionally participants will receive up to five AT devices tailored to their specific FI needs along with training on their usage All participants will be assessed at baseline post-intervention and six months after intervention The goals of the VIVE-AT are to encourage participants to use AT devices to self-manage their FDs and improve their quality of life Our approach will contribute to scientific knowledge and inform a subsequent scalable multisite Hybrid Type I RCT designed to evaluate its effectiveness in reducing physical FDs among older Latinos in primary healthcare settings in the US and PR
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None