Type 1 DiabetesNCT07212790
REAL-Fam Feasibility Study for Youth Diabetes Management
A study testing REAL-Fam Occupational Therapy Family Coaching in people with Type 1 Diabetes, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if the REAL-Fam occupational therapy intervention is feasible to study in a larger-scale randomized controlled trial. It will also seek to understand how the intervention influences how a rural family participates in and manages their child's type 1 diabetes, their family… Read more about this study
- Who is it for?
- Ages 2 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- REAL-Fam Occupational Therapy Family Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2025to Dec 2026
- 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 2 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Caregiver over 19 years old and designated guardian or parent to a child living with Type 1 Diabetes;
- Live in a rural area over 1 hour from pediatric endocrinology care team;
- Access to reliable internet
Who cannot join
- Caregiver who is not completing any supervision/support for their child's diabetes management;
- If the child is currently receiving occupational therapy services;
- Has a severe developmental, intellectual, or neurological disability
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
About this study
Official title: Feasibility of REAL-Fam to Support Diabetes Self-Management, Family Participation, and Child Health
The goal of this clinical trial is to learn if the REAL-Fam occupational therapy intervention is feasible to study in a larger-scale randomized controlled trial. It will also seek to understand how the intervention influences how a rural family participates in and manages their child's type 1 diabetes, their family quality of life, and the child's health outcomes. The main questions it aims to answer are:
- Primary Aim 1: Evaluate the recruitment capability, participant inclusion criteria, assessment selection and process, and data.
- Primary Aim 2: Evaluate the participant acceptability of and interventionist fidelity to the intervention.
- Secondary Aim: Evaluate families' preliminary outcomes to the REAL-Fam on family quality of life and participation, diabetes management self-efficacy, and child blood glucose stability.
Read more
Researchers will compare the REAL-Fam intervention to the Attention Group to see if there are changes in family diabetes-related health routines and psychosocial aspects of managing a child's type 1 diabetes.
Participants will:
- Children will wear continuous glucose monitors for study period
- Caregiver participants will complete baseline and post-intervention surveys
- Intervention Group: engage in 12 audio/video telehealth sessions with REAL-Fam intervention
- Attention Group: engage in 3 audio/video Zoom meetings without specialized services
- Complete a post-study interview
Read the detailed description
The prevalence of type 1 diabetes (T1D) is increasing among youth in the U.S., with higher incidence rates documented in rural communities compared to their urban peers. This rise is especially concerning for rural families, because they are at risk for healthcare disparities resulting from transportation challenges, lack of healthcare access, decreased financial stability, and other social determinants of health. The Resilient Empowered Active Living for Families (REAL-Fam) occupational therapy telehealth intervention provides a practical, immediate solution to increase access to low-cost, quality healthcare services for rural-dwelling caregivers and children living with T1D. Utilizing community-engaged research methods, this randomized clinical trial with follow-up interviews examines the feasibility of the 12-week REAL-Fam intervention group (n=8 dyads) compared to an attention group (n=8 dyads) for rural-dwelling caregiver/child dyads to improve the a) caregivers' diabetes management self-efficacy, b) caregivers' quality of life, and the c) children's glycemic levels. The REAL-Fam is innovative because it will extend diabetes care beyond glucose monitoring to include culturally sensitive healthcare experiences, family-centered behavioral interventions, healthy habit and routine training, and school and childcare participation strategies within the scope of occupational therapy. The successful evaluation of the REAL-Fam is critical to evaluate the protocol and support a full-scale clinical trial, which may inform other historically underrepresented socio-demographic groups that may not have access to ongoing diabetes healthcare services.
The findings from this study will inform healthcare practitioners, patients, and other stakeholders of the needs of rural families who are caring for a child with T1D and their urgent healthcare needs, such as improving quality of life and increasing access to specialized healthcare services. From the interdisciplinary team's past research focusing on T1D stakeholder needs in rural communities, it was apparent that many caregivers reported a need to access specialized diabetes care quicker after their child's diagnosis, which without this access they experienced poor health outcomes. Overall, successful evaluation of the REAL-Fam telehealth intervention is an important, necessary step to support future studies that may contribute to the advancement of T1D healthcare practices and improved child health outcomes for rural dwelling families.
- Conditions
- Type 1 Diabetes
- Being tested
- REAL-Fam Occupational Therapy Family Coaching
- Keywords
- Type 1 Diabetes, Rural Health, Occupational Therapy, Diabetes Management, Behavioral Health, Family-Centered Care, Psychosocial, Family Health, Diabetes, Behavioral Intervention, Child Health, Family Participation, Diabetes Quality of Life
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REAL-Fam Occupational Therapy Family CoachingBehavioural
The REAL-Fam draws on the expertise of occupational therapy in evaluating the fit between the demands of everyday activities and the skills and abilities of the parent-child dyads. The dyad and the occupational therapist will be equipped to co-develop personalized strategies to enable participation in these meaningful occupations. It facilitates the family's consistent, habitual, and effective performance of their child's diabetes management tasks into their personalized daily routines. Emphasis is on the creation or modification of family-centered diabetes management and routines and catered to the child's developmental needs. Due to the complexity of diabetes management cares and the child's age, the caregiver will be present for all sessions. When working towards a caregiver-centered outcome, the caregiver will participate with little child involvement. When working toward a child-centered outcome, the child will be the focus of that session.
| Study group | Role | What they receive |
|---|---|---|
| REAL-Fam Intervention Group | Experimental | 8 caregiver-child dyads will receive the Resilient, Empowered, Active Living for Families intervention. This is an occupational therapy family coaching intervention, which will be delivered via 12 weekly telehealth sessions. Receives: Behavioral: REAL-Fam Occupational Therapy Family Coaching |
| Attention Group | No intervention | 8 caregiver-child dyads will receive 3 attention group sessions with a research team member and engage in activities such as creating music play lists, playing games, and having conversation without specialized healthcare services. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Families Consented Versus Approached
One feasibility measure was to evaluate the number and percentage of families consented compared to those approached for participation in the study.
Measured: 12-week post treatment initiation
Number and Percentage of Standard of Care Condition Participants Retained vs Enrolled
Number and Percentage of standard of care condition participants retained in the study compared to those enrolled. Retention is defined as participants who completed post-intervention assessments.
Measured: 12-week post treatment initiation
Number and Percentage of Intervention Group Condition Participants Retained vs Enrolled
Number and Percentage of Intervention Group participants retained in the study compared to those enrolled. Retention is defined as participants who completed post-intervention assessments.
Measured: 12-week post treatment initiation
Number and Percentage of Surveys Completed by Participants Who Completed the Study
Number and Percentage of surveys over time completed by participants who completed the study.
Measured: 12-week post treatment initiation
Number and Percentage of attendance at telehealth sessions
The total number/amount of sessions attended out of the total number of sessions available, reported as both the total number and the percentage.
Measured: 12-week post treatment initiation
Number and percentage of dyads enrolled for the different recruitment strategies
For each recruitment strategy, the researchers will document the total number and percentage of how many families were eligible, approached, and enrolled
Measured: 12-week post treatment initiation
Telehealth Satisfaction Survey
A self-reported questionnaire for caregivers to rate how satisfied they were with the telehealth sessions (a measure of study acceptability). It includes 10 questions with 1-4 ratings, with higher scores indicating higher levels of satisfaction.
Measured: 12-week post treatment initiation
Training Satisfaction Rating Scale
A self-reported questionnaire for caregivers to rate their satisfaction with the REAL-Fam intervention. It includes the following subdomains: Objectives and content (3 questions); Method of training context (6 questions); Usefulness and overall rating (3 questions). Items are rated on a 1-5 scale, with higher scores indicating higher levels of acceptability.
Measured: 12-week post treatment initiation
Study Specific Interview Guide
A semi-structured interview guide to qualitatively assess feasibility and acceptability of the REAL-Fam intervention framework. It includes questions related to recruitment and enrollment (3 questions); scheduling and time commitment (3 questions); assessments and data collection (3 questions); technology use (2 questions); overall burden/ease (2 questions); perceived value of the intervention ( 2 questions); engagement and enjoyment (2 questions); format delivery (2 questions); relevance to family's life (2 questions); therapist interaction (2 questions); rural context (2 questions); modules and content (3 questions); habit \& routine focus of the intervention (3 questions); perceived changes/impact (2 questions); recommendations for improvement (2 questions); and overall reflections (2 questions). Qualitative results will be reported by each sub-domain.
Measured: 12-week post treatment initiation
Secondary outcomes (5)
WHO Quality of Life, Brief (WHOQOL-BREF)
Self-reported quality of life; higher score = better quality of life. The World Health Organization Quality of Life - BREF (WHOQOL-BREF) is a self-report questionnaire which assesses 4 domains of quality of life (QOL): physical health, psychological health, social relationships, and environment. In addition, there are 2 items that measure overall QOL and general health. Subscales (domains): Physical Health (7 items) Psychological Health (6 items) Social Relationships (3 items) Environment (8 items) Scoring: Items scored 1-5. Raw domain score is the sum of respective item scores. All domain scores are then normalized to a range of 0-100. Results reported by each sub-domain and by total score.
Measured: Baseline and 12-week post treatment initiation
Diabetes Health Management Performance Scale - Parents of Children
Self-reported performance in various diabetes health management tasks; higher score = higher level of performance with diabetes self management. Includes two parts to the assessment. Part A has the caregiver rate their performance in each category from the past 3 months. There are 5 subdomains: Diabetes Self-Management, (6 questions); Nutrition (2 questions); Physical Activity \& Exercise (2 questions); School and Childcare (3 questions); and Lifestyle Management (12 questions). Part B has the caregiver rate their child's performance in the following subdomains: Diabetes Self-Management (5 questions); Nutrition (2 questions); Physical Activity and Exercise (2 questions); School and Childcare (1 question); and Lifestyle Management (3 questions). Results reported by each subdomain.
Measured: Baseline and 12-week post treatment initiation
Problem Areas in Diabetes - Parents of Children
A self-reported questionnaire for caregivers to report any potential difficulties with managing their child's diabetes cares. It includes 16 questions, with a rating of 1-6, with higher scores indicating a more serious problem with managing their child's diabetes. Results reported as one total score.
Measured: Baseline and 12-week post treatment initiation
Diabetes Family Conflict Scale - Revised
A self-reported questionnaire for caregivers to report any potential family conflicts with managing their child's diabetes' cares. It includes 19 questions, with a 1-3 rating, and higher ratings indicating more family conflict.
Measured: Baseline and 12-week post treatment initiation
Self-Efficacy for Diabetes Scale (MSED)
A self-reported questionnaire for caregivers to report their confidence with managing their child's diabetes self-cares. Includes 17 questions, on a 1-5 rating, with higher scores indicating higher levels of confidence in completing diabetes self management.
Measured: Baseline and 12-week post treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start15 Dec 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There will be an intervention group and an attention group participating over the same 14 week study period.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- American Occupational Therapy Foundation, Creighton University, DexCom, Inc., University of Southern California
- Responsible party
- Sponsor
- Investigators
- Vanessa Jewell, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07212790
- Sponsor's protocol ID
- 25-0708
- Status last verified
- Oct 2025
- First submitted
- 22 Sep 2025
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina at Chapel Hill.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of REAL-Fam to Support Diabetes Self-Management, Family Participation, and Child Health
- ClinicalTrials.gov ID
- NCT07212790
- Acronym / sponsor ID
- 25-0708
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 Diabetes, Rural Health, Occupational Therapy, Diabetes Management, Behavioral Health, Family-Centered Care, Psychosocial, Family Health
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- American Occupational Therapy Foundation, Creighton University, DexCom, Inc., University of Southern California
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Oct 2025 (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.
The goal of this clinical trial is to learn if the REAL-Fam occupational therapy intervention is feasible to study in a larger-scale randomized controlled trial. It will also seek to understand how the intervention influences how a rural family participates in and manages their child's type 1 diabetes, their family quality of life, and the child's health outcomes. The main questions it aims to answer are:
- Primary Aim 1: Evaluate the recruitment capability, participant inclusion criteria, assessment selection and process, and data.
- Primary Aim 2: Evaluate the participant acceptability of and interventionist fidelity to the intervention.
- Secondary Aim: Evaluate families' preliminary outcomes to the REAL-Fam on family quality of life and participation, diabetes management self-efficacy, and child blood glucose stability.
Researchers will compare the REAL-Fam intervention to the Attention Group to see if there are changes in family diabetes-related health routines and psychosocial aspects of managing a child's type 1 diabetes.
Participants will:
- Children will wear continuous glucose monitors for study period
- Caregiver participants will complete baseline and post-intervention surveys
- Intervention Group: engage in 12 audio/video telehealth sessions with REAL-Fam intervention
- Attention Group: engage in 3 audio/video Zoom meetings without specialized services
- Complete a post-study interview
Detailed description
The prevalence of type 1 diabetes (T1D) is increasing among youth in the U.S., with higher incidence rates documented in rural communities compared to their urban peers. This rise is especially concerning for rural families, because they are at risk for healthcare disparities resulting from transportation challenges, lack of healthcare access, decreased financial stability, and other social determinants of health. The Resilient Empowered Active Living for Families (REAL-Fam) occupational therapy telehealth intervention provides a practical, immediate solution to increase access to low-cost, quality healthcare services for rural-dwelling caregivers and children living with T1D. Utilizing community-engaged research methods, this randomized clinical trial with follow-up interviews examines the feasibility of the 12-week REAL-Fam intervention group (n=8 dyads) compared to an attention group (n=8 dyads) for rural-dwelling caregiver/child dyads to improve the a) caregivers' diabetes management self-efficacy, b) caregivers' quality of life, and the c) children's glycemic levels. The REAL-Fam is innovative because it will extend diabetes care beyond glucose monitoring to include culturally sensitive healthcare experiences, family-centered behavioral interventions, healthy habit and routine training, and school and childcare participation strategies within the scope of occupational therapy. The successful evaluation of the REAL-Fam is critical to evaluate the protocol and support a full-scale clinical trial, which may inform other historically underrepresented socio-demographic groups that may not have access to ongoing diabetes healthcare services.
The findings from this study will inform healthcare practitioners, patients, and other stakeholders of the needs of rural families who are caring for a child with T1D and their urgent healthcare needs, such as improving quality of life and increasing access to specialized healthcare services. From the interdisciplinary team's past research focusing on T1D stakeholder needs in rural communities, it was apparent that many caregivers reported a need to access specialized diabetes care quicker after their child's diagnosis, which without this access they experienced poor health outcomes. Overall, successful evaluation of the REAL-Fam telehealth intervention is an important, necessary step to support future studies that may contribute to the advancement of T1D healthcare practices and improved child health outcomes for rural dwelling families.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- There will be an intervention group and an attention group participating over the same 14 week study period.
| Arm | Type | Receives |
|---|---|---|
| REAL-Fam Intervention Group | Experimental | Behavioral: REAL-Fam Occupational Therapy Family Coaching8 caregiver-child dyads will receive the Resilient, Empowered, Active Living for Families intervention. This is an occupational therapy family coaching intervention, which will be delivered via 12 weekly telehealth sessions. |
| Attention Group | No intervention | –8 caregiver-child dyads will receive 3 attention group sessions with a research team member and engage in activities such as creating music play lists, playing games, and having conversation without specialized healthcare services. |
Who may qualify
- Ages
- 2 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Caregiver over 19 years old and designated guardian or parent to a child living with Type 1 Diabetes;
- Live in a rural area over 1 hour from pediatric endocrinology care team;
- Access to reliable internet
Key exclusion criteria (3 listed)
- Caregiver who is not completing any supervision/support for their child's diabetes management;
- If the child is currently receiving occupational therapy services;
- Has a severe developmental, intellectual, or neurological disability
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 |
|---|---|---|
| REAL-Fam Occupational Therapy Family CoachingThe REAL-Fam draws on the expertise of occupational therapy in evaluating the fit between the demands of everyday activities and the skills and abilities of the parent-child dyads. The dyad and the occupational therapist will be equipped to co-develop personalized strategies to enable participation in these meaningful occupations. It facilitates the family's consistent, habitual, and effective performance of their child's diabetes management tasks into their personalized daily routines. Emphasis is on the creation or modification of family-centered diabetes management and routines and catered to the child's developmental needs. Due to the complexity of diabetes management cares and the child's age, the caregiver will be present for all sessions. When working towards a caregiver-centered outcome, the caregiver will participate with little child involvement. When working toward a child-centered outcome, the child will be the focus of that session. | Behavioural | REAL-Fam Intervention Group |
Primary outcome
Percentage of Families Consented Versus Approached
Time frame: 12-week post treatment initiation
One feasibility measure was to evaluate the number and percentage of families consented compared to those approached for participation in the study.
Number and Percentage of Standard of Care Condition Participants Retained vs Enrolled
Time frame: 12-week post treatment initiation
Number and Percentage of standard of care condition participants retained in the study compared to those enrolled. Retention is defined as participants who completed post-intervention assessments.
Number and Percentage of Intervention Group Condition Participants Retained vs Enrolled
Time frame: 12-week post treatment initiation
Number and Percentage of Intervention Group participants retained in the study compared to those enrolled. Retention is defined as participants who completed post-intervention assessments.
Number and Percentage of Surveys Completed by Participants Who Completed the Study
Time frame: 12-week post treatment initiation
Number and Percentage of surveys over time completed by participants who completed the study.
Number and Percentage of attendance at telehealth sessions
Time frame: 12-week post treatment initiation
The total number/amount of sessions attended out of the total number of sessions available, reported as both the total number and the percentage.
Number and percentage of dyads enrolled for the different recruitment strategies
Time frame: 12-week post treatment initiation
For each recruitment strategy, the researchers will document the total number and percentage of how many families were eligible, approached, and enrolled
Telehealth Satisfaction Survey
Time frame: 12-week post treatment initiation
A self-reported questionnaire for caregivers to rate how satisfied they were with the telehealth sessions (a measure of study acceptability). It includes 10 questions with 1-4 ratings, with higher scores indicating higher levels of satisfaction.
Training Satisfaction Rating Scale
Time frame: 12-week post treatment initiation
A self-reported questionnaire for caregivers to rate their satisfaction with the REAL-Fam intervention. It includes the following subdomains: Objectives and content (3 questions); Method of training context (6 questions); Usefulness and overall rating (3 questions). Items are rated on a 1-5 scale, with higher scores indicating higher levels of acceptability.
Study Specific Interview Guide
Time frame: 12-week post treatment initiation
A semi-structured interview guide to qualitatively assess feasibility and acceptability of the REAL-Fam intervention framework. It includes questions related to recruitment and enrollment (3 questions); scheduling and time commitment (3 questions); assessments and data collection (3 questions); technology use (2 questions); overall burden/ease (2 questions); perceived value of the intervention ( 2 questions); engagement and enjoyment (2 questions); format delivery (2 questions); relevance to family's life (2 questions); therapist interaction (2 questions); rural context (2 questions); modules and content (3 questions); habit \& routine focus of the intervention (3 questions); perceived changes/impact (2 questions); recommendations for improvement (2 questions); and overall reflections (2 questions). Qualitative results will be reported by each sub-domain.
5 secondary outcomes
WHO Quality of Life, Brief (WHOQOL-BREF)
Time frame: Baseline and 12-week post treatment initiation
Diabetes Health Management Performance Scale - Parents of Children
Time frame: Baseline and 12-week post treatment initiation
Problem Areas in Diabetes - Parents of Children
Time frame: Baseline and 12-week post treatment initiation
Diabetes Family Conflict Scale - Revised
Time frame: Baseline and 12-week post treatment initiation
Self-Efficacy for Diabetes Scale (MSED)
Time frame: Baseline and 12-week post treatment initiation
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 Aug 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina at Chapel Hill.
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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. This study is not recruiting at the moment.
Vanessa Jewell, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REAL-Fam Occupational Therapy Family Coaching in people with Type 1 Diabetes, run by University of North Carolina, Chapel Hill at 1 site in United States.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 13 Aug 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 United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Families Consented Versus Approached (time frame: 12-week post treatment initiation). The study lists 9 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 Aug 2026.