AgingNCT06425510
Using Technology to Improve Function for Older Latinos With Disabilities in Underserved Areas
A study testing Translation: Living the Advantages of Technological Assistance (VIVE-AT) and Attention calls in people with Aging and Disability Physical, run by University of Puerto Rico at 1 site in Puerto Rico.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aging, Disability Physical
- What is being tested?
- Translation: Living the Advantages of Technological Assistance (VIVE-AT) and Attention calls
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 sitePuerto Rico
- Study dates
- 1 Aug 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Puerto Rico1 site
University of Puerto Rico Medical Sciences Campus
San Juan, 00936-5067
Elsa M Orellano-Colón, Ph.D., 787-758-2525 ext. 4200, elsa.orellano@upr.edu
Milagros I Figueroa-Ramos, Ph.D., 787-758-2525 ext. 1986, milagros.figueroa@upr.edu
About this study
Official title: Tech Enabled Functional Health: Bridging Primary Care Gaps for Older Latinos With Functional Disabilities in Underserved Communities
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.
Read the 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:
- refine the protocol of the VIVE-AT to align with the unique needs of the primary health care clinic;
- 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;
- 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
- Being tested
- Translation: Living the Advantages of Technological Assistance (VIVE-AT), Attention calls
- Keywords
- self help devices, behavioral intervention, assistive technology, primary health care, community health workers, older Latinos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Translation: Living the Advantages of Technological Assistance (VIVE-AT)Behavioural
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.
Attention callsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| (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. Receives: 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. Receives: Other: Attention calls |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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).
Measured: 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)
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.
Measured: 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)
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).
Measured: 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)
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.
Measured: 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
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.
Measured: 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
This 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.
Measured: Baseline, at the end of the intervention (6 weeks), and at 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start1 Aug 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Social Cognitive Theory
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Puerto Rico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06425510
- Sponsor's protocol ID
- 2405230330
- Status last verified
- Apr 2026
- First submitted
- 17 May 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified quantitative data that can be publicly shared will be formatted for widely available statistical packages such as R, Statistical Package for the Social Sciences (SPSS), STATA, and Statistical Analysis System (SAS). All shared study materials, data, and metadata will be made publicly available through the University of Puerto Rico Institutional Repository at the University of Puerto Rico Institutional Digital Repository website at https://repositorio.upr.edu/. Data will be assigned a Digital Object Identifier (DOI) and searchable via the University of Puerto Rico Institutional Repository and other search engines.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tech Enabled Functional Health: Bridging Primary Care Gaps for Older Latinos With Functional Disabilities in Underserved Communities
- ClinicalTrials.gov ID
- NCT06425510
- Acronym / sponsor ID
- 2405230330
- Conditions
- Aging, Disability Physical
- Keywords
- self help devices, behavioral intervention, assistive technology, primary health care, community health workers, older Latinos
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- University of Puerto RicoUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- refine the protocol of the VIVE-AT to align with the unique needs of the primary health care clinic;
- 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;
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Social Cognitive Theory
| Arm | Type | Receives |
|---|---|---|
| (VIVE-AT) - Translation: Living the Advantages of Technological Assistance | Experimental | Behavioral: Translation: Living the Advantages of Technological Assistance (VIVE-AT)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. |
| Waitlist Control | Active comparator | Other: Attention callsParticipants 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | (VIVE-AT) - Translation: Living the Advantages of Technological Assistance |
| Attention callsTen 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. | Other | Waitlist Control |
Primary outcome
Physical Function as Assessed by the PROMIS Short Form v2.0 - Physical Function 24a (PROMIS-HAQ)
Time frame: Baseline, at the end of the intervention (6 weeks), and at 6 months post-intervention
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".
Quality of Life as Assessed by PROMIS Scale v1.2 - Global Health
Time frame: Baseline, at the end of the intervention (6 weeks), and at 6 months post-intervention
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).
5 secondary outcomes
Use of Assistive Technology Devices as Assessed by Assistive Technology Awareness Scale (ATUAS)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: Baseline, at the end of the intervention (6 weeks), and at 6 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Yes. De-identified quantitative data that can be publicly shared will be formatted for widely available statistical packages such as R, Statistical Package for the Social Sciences (SPSS), STATA, and Statistical Analysis System (SAS). All shared study materials, data, and metadata will be made publicly available through the University of Puerto Rico Institutional Repository at the University of Puerto Rico Institutional Digital Repository website at https://repositorio.upr.edu/. Data will be assigned a Digital Object Identifier (DOI) and searchable via the University of Puerto Rico Institutional Repository and other search engines.
Related trials for Aging
Enrolling by invitationPhase 2
Tirzepatide and Organ-specific Biological Aging
Longevity, Preventive Medicine
Active, not recruiting
Emotional Well-being and Measures of Healthy Aging
Aging, Aging, Healthy
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Active, not recruiting
Vascular Aging and Lp299v Study in Healthy Adults
Vascular Aging
RecruitingObservational study
Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging
Aging
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Translation: Living the Advantages of Technological Assistance (VIVE-AT) and Attention calls in people with Aging and Disability Physical, run by University of Puerto Rico at 1 site in Puerto Rico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elsa M Orellano-Colón, Ph.D. (787-758-2525 ext. 4200, elsa.orellano@upr.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Function as Assessed by the PROMIS Short Form v2.0 - Physical Function 24a (PROMIS-HAQ) (time frame: Baseline, at the end of the intervention (6 weeks), and at 6 months post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.