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

NCT06425510 | Not Yet Recruiting

• 1 other identifier: 2405230330
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging; Disability Physical

Keywords

self help devices; behavioral intervention; assistive technology; primary health care; community health workers; older Latinos

Outcome Measures

Primary Outcomes (2)

• Physical Function as Assessed by the PROMIS Short Form v2.0 - Physical Function 24a (PROMIS-HAQ)

  This is a patient-reported outcome measure designed to assess physical FDs in adults across the categories of dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, errands, and chores. It comprises 20 items on a 5-point Likert-type scale, ranging from 5 "without difficulty" to 1 "unable to do".

  Baseline, at the end of the intervention (6 weeks), and at 6 months post-intervention

• Quality of Life as Assessed by PROMIS Scale v1.2 - Global Health

  This is a 10-item health-related quality of life measure with five domains: physical health, pain, fatigue, mental health, and social health, along with an overall health assessment. It also includes two subscales: Global Mental Health (GMH) and Global Physical Health (GPH).

  Baseline, at the end of the intervention (6 weeks), and at 6 months post-intervention

Secondary Outcomes (5)

• Use of Assistive Technology Devices as Assessed by Assistive Technology Awareness Scale (ATUAS)

  Baseline, at the end of the intervention (6 weeks), and at 6 months post-intervention

• Assistive Technology Knowledge as Assessed by Assistive Technology Use and Awareness Scale (ATUAS)

  Baseline, at the end of the intervention (6 weeks), and at 6 months post-intervention

• Motivation to Use Assistive Technology as Assessed by Attitudes Towards Assistive Device Scale (AADS)

  Baseline, at the end of the intervention (6 weeks), and at 6 months post-intervention

• Intention to Use Assistive Technology as Assessed by Intention to Use Assistive Device Scale

  Baseline, at the end of the intervention (6 weeks), and at 6 months post-intervention

• Self-efficacy as Assessed by Self-efficacy Regarding Assistive Device Use

  Baseline, at the end of the intervention (6 weeks), and at 6 months post-intervention

Other Outcomes (6)

• Participation rates

  At the end of the intervention (6 weeks)

• Retention rates

  At the end of the intervention (6weeks) and at 6 months post-intervention

• Attrition rates

  At the end of the intervention (6 weeks) and 6 months post-intervention

Study Arms (2)

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

EXPERIMENTAL

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.

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

Waitlist Control

ACTIVE COMPARATOR

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.

Other: Attention calls

Interventions

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

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

Attention calls 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.

Waitlist Control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Puerto Rico: lead

Study Sites (1)

University of Puerto Rico Medical Sciences Campus

San Juan, 00936-5067, Puerto Rico

Location

Central Study Contacts

Elsa M Orellano-Colón, Ph.D.

CONTACT

787-758-2525; elsa.orellano@upr.edu

Milagros I Figueroa-Ramos, Ph.D.

CONTACT

787-758-2525; milagros.figueroa@upr.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Social Cognitive Theory

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: May 22, 2024
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data and metadata will be deposited into the repository at the time of publication or by the end of the project period, whichever comes first. Data will be preserved for three years following the end of the grant period.
• Access Criteria: The study's Individual Participant Data (IPD) would be accessible to the academic community and the public. This repository serves as a digital storage site for the scientific and creative work of the University of Puerto Rico. They will be able to access all shared study materials, data, and metadata. To access the repository, users can visit the University of Puerto Rico Digital Institutional Repository website at https://repositorio.upr.edu. The repository allows for the searching and browsing of content, which includes faculty research works.

Locations

PR (1)