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

Tech Enabled Functional Health: Bridging Primary Care Gaps for Older Latinos With Functional Disabilities in Underserved Communities

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06425510
Enrollment
76
Registered
2024-05-22
Start date
2026-08-01
Completion date
2027-12-31
Last updated
2026-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Disability Physical

Keywords

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

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.

Interventions

BEHAVIORALTranslation: 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.

OTHERAttention 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.

Sponsors

University of Puerto Rico
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Social Cognitive Theory

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Physical Function as Assessed by the PROMIS Short Form v2.0 - Physical Function 24a (PROMIS-HAQ)Baseline, at the end of the intervention (6 weeks), and at 6 months post-interventionThis 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".
Quality of Life as Assessed by PROMIS Scale v1.2 - Global HealthBaseline, at the end of the intervention (6 weeks), and at 6 months post-interventionThis 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).

Secondary

MeasureTime frameDescription
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-interventionThe ATUAS assesses participants' knowledge of 44 assistive technology devices. Participants are presented with photographs and names of the devices and asked if they possess each item. If the answer is 'No,' further questions will determine whether they use it (code 2) or not (code 1), are aware of its existence (code 3), or neither (code 4). Responses will be recoded into two categories: used (code 2) and not used (codes 1, 3, and 4) to calculate assistive technology device usage.
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-interventionThe ATUAS assesses participants' knowledge of 44 assistive technology devices. Participants are presented with photographs and names of the devices and asked if they possess each item. If the answer is 'No,' further questions will determine whether they use it (code 2) or not (code 1), are aware of its existence (code 3), or neither (code 4). Assistive technology knowledge is assessed by re-coding the answer for each assistive technology into two categories: aware (codes 1, 2, 3) versus not aware (code 4).
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-interventionThe AADS consists of 12 items designed to measure older adults' attitudes (motivation), including the substitution of care, the financial aspect of care, and the effect on privacy. It utilizes a Likert scale with 5 points, ranging from 5 (totally agree) to 1 (totally disagree), with interval scores ranging from 12 to 60. A high score indicates a positive attitude.
Intention to Use Assistive Technology as Assessed by Intention to Use Assistive Device ScaleBaseline, at the end of the intervention (6 weeks), and at 6 months post-interventionThis measure consists of three items presenting increasing levels of intention (motivation) to use assistive technology devices. It employs a 5-point Likert scale, ranging from 1 (I do not have the intention to do this at all) to 5 (I certainly have the intention to do this). The total score ranges from 3 to 15; higher scores indicate a strong intention to use assistive technology devices.
Self-efficacy as Assessed by Self-efficacy Regarding Assistive Device UseBaseline, at the end of the intervention (6 weeks), and at 6 months post-interventionThis measure assesses self-efficacy for using assistive technology devices with three items, each representing increasing barriers. The interval scale ranges from 3 to 15; a higher score indicates higher self-efficacy.

Countries

Puerto Rico

Contacts

CONTACTElsa M Orellano-Colón, Ph.D.
elsa.orellano@upr.edu787-758-2525
CONTACTMilagros I Figueroa-Ramos, Ph.D.
milagros.figueroa@upr.edu787-758-2525

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 14, 2026