Using Technology to Improve Function for Older Latinos With Disabilities in Underserved Areas

NCT ID: NCT06425510

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2027-05-31

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 (n=38) or a waitlist + attention calls controlled condition group (n=38) 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 AT. Additionally, participants will receive up to five AT devices tailored to their specific functional disabilities 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. This approach will contribute to scientific knowledge and inform a subsequent scalable multisite Hybrid Type I Randomized Controlled Trial designed to evaluate its effectiveness in reducing physical function disabilities among older Latinos in primary healthcare settings in the U.S. and P.R.

Conditions

Aging; Disability Physical

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

(VIVE-AT) - Translation: Living the Advantages of Technological Assistance

The VIVE-AT program consists of a six-week, once-a-week, 2-hour group educational intervention guided by the social cognitive model. It is facilitated by primary care and community health workers in a primary healthcare clinic. The intervention aims to teach older Latinos self-management strategies to increase the adoption and use of assistive technology devices that enhance their function in daily activities. VIVE-AT is designed to support behavioral change by providing up to five assistive technology devices to participants, along with information, instruction, demonstration, action planning, and guided practice in using the devices.

Group Type: EXPERIMENTAL

Translation: Living the Advantages of Technological Assistance (VIVE-AT)

Intervention Type: BEHAVIORAL

It comprises 2-hour small group sessions of 8-10 participants, once a week, for six weeks of participatory discussions, experiential learning, multimodal instructions, and demonstration and practice with selected assistive technology devices (ATDs). The content of the VIVE-AT weekly sessions is as follows: Week 1 - Introduction to ATDs, funding, and resources; Week 2 - ATDs for self-care and toilet use; Week 3 - ATDs for mobility; Week 4 - ATDs for dressing; Week 6 - ATDs for cooking and home tasks. Each session is designed with the following components: monitoring of participants\' weekly goals; providing information on ATDs, resources, and services; reflection on the advantages and disadvantages of using these ATDs; hands-on practice with selected ATDs; goal setting and addressing barriers to using ATDs. Group sessions will incorporate visual aids, including modeling and videos of older individuals using ATDs accessed through an AT web app in a tablet provided by this project.

Waitlist Control

Participants in the waitlist control group will receive weekly attention calls providing general health advice during the 6-week intervention period. They will also receive usual care for the initial 6 months post-randomization, followed by crossover to the VIVE-AT intervention.

Group Type: ACTIVE_COMPARATOR

Attention calls

Intervention Type: OTHER

Ten minutes of attention calls, once a week for six weeks, to the waitlist control participants will offer general health advice on topics like nutrition, exercise, sleep, stress, and social connections. These calls emphasize participant well-being without touching upon the specific VIVE-AT content, maintaining a clear distinction from the intervention group.

Interventions

Translation: Living the Advantages of Technological Assistance (VIVE-AT)

It comprises 2-hour small group sessions of 8-10 participants, once a week, for six weeks of participatory discussions, experiential learning, multimodal instructions, and demonstration and practice with selected assistive technology devices (ATDs). The content of the VIVE-AT weekly sessions is as follows: Week 1 - Introduction to ATDs, funding, and resources; Week 2 - ATDs for self-care and toilet use; Week 3 - ATDs for mobility; Week 4 - ATDs for dressing; Week 6 - ATDs for cooking and home tasks. Each session is designed with the following components: monitoring of participants\' weekly goals; providing information on ATDs, resources, and services; reflection on the advantages and disadvantages of using these ATDs; hands-on practice with selected ATDs; goal setting and addressing barriers to using ATDs. Group sessions will incorporate visual aids, including modeling and videos of older individuals using ATDs accessed through an AT web app in a tablet provided by this project.

Intervention Type: BEHAVIORAL

Attention calls

Ten minutes of attention calls, once a week for six weeks, to the waitlist control participants will offer general health advice on topics like nutrition, exercise, sleep, stress, and social connections. These calls emphasize participant well-being without touching upon the specific VIVE-AT content, maintaining a clear distinction from the intervention group.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Spanish speaking Latino adults ≥65 years
• With a physical function impairment (PROMIS-HAQ T-Score ≤45)
• Living independently in the community (not requiring supervision to perform their daily living activities)
• Self-reported ability to participate in a 6 weeks of group intervention
• Having no plans to move for the next 12 months

Exclusion Criteria

• Currently residing in a nursing or group home
• Receiving home healthcare services
• Having a significant cognitive impairment as evidenced by a score ≤23 in the Mini Mental State Examination (MMSE)

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Puerto Rico

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Puerto Rico Medical Sciences Campus

San Juan, , Puerto Rico

Countries

Puerto Rico

Central Contacts

Elsa M Orellano-Colón, Ph.D.

Role: CONTACT

elsa.orellano@upr.edu

787-758-2525 ext. 4200

Milagros I Figueroa-Ramos, Ph.D.

Role: CONTACT

milagros.figueroa@upr.edu

787-758-2525 ext. 1986

Facility Contacts

Elsa M Orellano-Colón, Ph.D.

Role: primary

elsa.orellano@upr.edu

787-758-2525 ext. 4200

Milagros I Figueroa-Ramos, Ph.D.

Role: backup

milagros.figueroa@upr.edu

787-758-2525 ext. 1986

Other Identifiers

2405230330

Identifier Type: -

Identifier Source: org_study_id