Using Technology to Improve Function for Older Latinos With Disabilities in Underserved Areas
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity of Puerto Rico
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Translation: Living the Advantages of Technological Assistance (VIVE-AT)
BehavioralIt 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.
Attention calls
Other interventionTen 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.
Treatment groups
76 Participants
are divided into 2 treatment groupsGroup A: (VIVE-AT) - Translation: Living the Advantages of Technological AssistanceExperimental treatment 1 intervention
Group B: Waitlist ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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".
Time frame
Baseline, at the end of the intervention (6 weeks), and at 6 months post-intervention2
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).
Time frame
Baseline, at the end of the intervention (6 weeks), and at 6 months post-interventionSecondary outcomes
1
Use of Assistive Technology Devices as Assessed by Assistive Technology Awareness Scale (ATUAS)
The 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.
Time frame
Baseline, at the end of the intervention (6 weeks), and at 6 months post-intervention2
Assistive Technology Knowledge as Assessed by Assistive Technology Use and Awareness Scale (ATUAS)
The 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).
Time frame
Baseline, at the end of the intervention (6 weeks), and at 6 months post-intervention3
Motivation to Use Assistive Technology as Assessed by Attitudes Towards Assistive Device Scale (AADS)
The 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.
Time frame
Baseline, at the end of the intervention (6 weeks), and at 6 months post-intervention4
Intention to Use Assistive Technology as Assessed by Intention to Use Assistive Device Scale
This 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.
Time frame
Baseline, at the end of the intervention (6 weeks), and at 6 months post-interventionOther outcomes
1
Participation rates
The percent of eligible older Latinos who were enrolled (goal: ≥ 80%)
Time frame
At the end of the intervention (6 weeks)2
Retention rates
The percent of older Latinos who complete the study measures at the end of the intervention and at 6 months post-intervention (goal: ≥ 80%).
Time frame
At the end of the intervention (6weeks) and at 6 months post-intervention3
Attrition rates
The percent of participants who drop out or are lost to follow-up at the end of the intervention and at 6 months post-intervention, with reasons recorded when known (goal: ≤ 20%).
Time frame
At the end of the intervention (6 weeks) and 6 months post-intervention4
Completion rates
The percent of participants completing at least 4 of 6 group sessions (goal: ≥ 80%).
Time frame
At 6 months post-interventionSponsors and contacts
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Source ClinicalTrials.gov
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