Clinical trial NCT06425510: Using Technology to Improve Function for Older Latinos With Disabilities in Underserved Areas
Official title: Tech Enabled Functional Health: Bridging Primary Care Gaps for Older Latinos With Functional Disabilities in Underserved Communities
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Aging
Disability Physical
Keywords: self help devices
behavioral intervention
assistive technology
primary health care
community health workers
older Latinos
Lead sponsor: University of Puerto Rico
Sponsor class: OTHER
First posted: 2024-05-22
Enrollment: 76
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Social Cognitive Theory
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Physical Function as Assessed by the PROMIS Short Form v2.0 - Physical Function 24a (PROMIS-HAQ)
timeFrame: Baseline, at the end of the intervention (6 weeks), and at 6 months post-intervention
measure: Quality of Life as Assessed by PROMIS Scale v1.2 - Global Health
timeFrame: Baseline, at the end of the intervention (6 weeks), and at 6 months post-intervention
Secondary outcomes:
measure: Use of Assistive Technology Devices as Assessed by Assistive Technology Awareness Scale (ATUAS)
timeFrame: Baseline, at the end of the intervention (6 weeks), and at 6 months post-intervention
measure: Assistive Technology Knowledge as Assessed by Assistive Technology Use and Awareness Scale (ATUAS)
timeFrame: Baseline, at the end of the intervention (6 weeks), and at 6 months post-intervention
measure: Motivation to Use Assistive Technology as Assessed by Attitudes Towards Assistive Device Scale (AADS)
timeFrame: Baseline, at the end of the intervention (6 weeks), and at 6 months post-intervention
measure: Intention to Use Assistive Technology as Assessed by Intention to Use Assistive Device Scale
timeFrame: Baseline, at the end of the intervention (6 weeks), and at 6 months post-intervention
measure: Self-efficacy as Assessed by Self-efficacy Regarding Assistive Device Use
timeFrame: Baseline, at the end of the intervention (6 weeks), and at 6 months post-intervention
Other outcomes:
measure: Participation rates
timeFrame: At the end of the intervention (6 weeks)
measure: Retention rates
timeFrame: At the end of the intervention (6weeks) and at 6 months post-intervention
measure: Attrition rates
timeFrame: At the end of the intervention (6 weeks) and 6 months post-intervention
measure: Completion rates
timeFrame: At 6 months post-intervention
measure: Acceptability as Assessed by Acceptability: Assessment will be conducted using the Intervention Acceptability and Implementation Questionnaire
timeFrame: At the end of the intervention (6 weeks)
measure: Cost
timeFrame: Baseline, during the intervention, at the end of the intervention (6 weeks), and at 6 months post-intervention
Locations:
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico Medical Sciences Campus
Study officials:
References: