Malnutrition; ProteinNCT05893446
Essential Connections: Hospital to Community Impacting Malnutrition Outcomes in Older Adults
A study testing Nutrition care by RDN, medical nutrition therapy -stepped wedge cluster-randomized trial design. Everyone gets the intervention so no arms. in people with Malnutrition; Protein, run by Academy of Nutrition and Dietetics.
Trial summary
Meal provision organizations, whether they provide meals within the home or in congregate centers, provide an excellent opportunity to address malnutrition by providing nutrition care and meals to those who are most vulnerable. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Malnutrition; Protein
- What is being tested?
- Nutrition care by RDN, medical nutrition therapy -stepped wedge cluster-randomized trial design. Everyone gets the intervention so no arms.
- How many people
- 1,120 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 31 May 2028
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English or Spanish speaking,
- Screened as at risk for malnutrition (Malnutrition Screening Tool),
- Meet the definition for food insecure per the Food Security Risk tool,
- Referred to an RDN,
- Diagnosed with malnutrition using AAIM,
- Plan for discharge to home, and
- Eligible to receive Title III-C1 or Title III-C2 nutrition services.
Who cannot join
- Patients are receiving hospice care or care for end stage cancer,
- Unable to consume meals (e.g., using enteral or parenteral to meet nutrition needs), Do not live within the meal provision organizations catchment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Essential Connections: How Improved Referrals From Hospital to Community Meal Provision Can Impact Malnutrition Outcomes in Older Adults
Meal provision organizations, whether they provide meals within the home or in congregate centers, provide an excellent opportunity to address malnutrition by providing nutrition care and meals to those who are most vulnerable. Data has shown that nutrition care within the home by a dietitian can increase energy, protein intake, and body weight. The goal of this study is to test a new model for continuity of nutrition care for malnutrition treatment across settings and determine if it improves food security and quality of life in patients 60 years and older. The study will specifically recruit sites and a sample that represents individuals who have malnutrition, have experienced or are at risk for food insecurity, and those from rural areas as well as Black, Latino, Indigenous and Native American populations with a goal sample size of 1,120 patients over the five-year duration. The objectives of this study are to: 1) test the feasibility of a patient identification, cross-referral, data reporting, and communication process from an acute care hospital to a community meal provision organization; 2) identify barriers to and facilitators for implementation as well as costs of the new model of continuity of nutrition care across settings; and 3) improve food security, determinants of malnutrition, and quality of life in persons older than 60 years of age discharged from the hospital with a diagnosis of malnutrition. Level 1 evidence will be generated from the study. The outcomes to be measured are program sustainability, percent change in referrals, food insecurity, malnutrition risk and diagnosis, and quality of life. The results of this study can provide a new model for nutrition care that may improve food security, quality of life, and health outcomes.
Read the detailed description
We hypothesize that enhanced continuity of nutrition care between acute care hospital settings and community meal provision organizations providing Title III-C Special Need Plan services (C1 and C2) will be sustainable and improve outcomes for patients older than 60 years of age who are diagnosed with malnutrition. Specifically, the enhanced continuity of care will: a) increase referrals and communication between clinical and community nutrition care providers at each study site location; b) increase the percent of patients receiving nutrition care within the community setting; and c) improve food security, quality of life, and reduce determinants of malnutrition.
To test this hypothesis, we propose to conduct a study which will examine a new model of continuity of nutrition care for sustainability and impact. The model has been developed to facilitate cross-referrals and transmission of structured nutrition care documentation from an acute care setting to a meal provision organization and then for the meal provision organization to use the referral data to increase delivery of nutrition care (medical nutrition therapy- MNT) and meals (medically tailored meals - MTM). The primary subjects for this study are adults older than 60 years of age with malnutrition, with particular emphasis on recruiting sites who serve individuals who are Black, Latino, Indigenous and Native Americans and individuals living in rural areas of the country.
The components of the proposed new model of cross-referral, data transfer, and nutrition care across settings has the potential to be scalable throughout the US. However, barriers and facilitators to data transfer and MNT/MTM provision, cost of implementation, and potential impact on outcomes must be evaluated for the model to be replicable. The results of this study will generate new data on the model of care feasibility, rates of malnutrition within older adults at the study sites, impact of MNT with MTM provision on food security, determinants of malnutrition, and quality of life to inform future scalability of the model.
Goals and Objectives The goal of this new model is to improve food security and quality of life in patients 60 years and older from key vulnerable populations with greatest social and economic need by providing continuity of nutrition care for malnutrition treatment across settings. To test the feasibility of this new model, we will use a stepped wedge cluster-randomized trial design at eight sites throughout the US, specifically recruiting sites and individuals who are Black, Latino, Indigenous and Native American, and individuals living in rural areas of the country. The Academy of Nutrition and Dietetics (the Academy), as the research organization, and the Academy of Nutrition and Dietetics Foundation (Academy Foundation) will partner with collaborating organizations in both acute care hospitals and meal provision organizations (Title III-C1 and C2) within the community to test the newly developed model.
Objective 1) To test the feasibility of a patient identification, cross-referral, data reporting, and communication (including data transfer) process from an acute care hospital to a community meal provision organization.
Objective 1a) To identify barriers to and facilitators for implementation as well as the cost of the new model of continuity of nutrition care across settings.
Objective 2) To increase the rate of patients older than 60 years of age with malnutrition receiving care (MNT, MTM) in the community setting.
Objective 3) To improve food security, determinants of malnutrition, and quality of life in persons older than 60 years of age discharged from the hospital with a diagnosis of malnutrition.
There are two distinct portions of the study intervention: the clinical component, which includes patient identification, effective cross-referrals, and enhanced data reporting and transfer to the community partner, and the community component, including enhanced nutrition care and reporting including both MNT and MTM. The meals and nutrition care within the community can occur at home or within a congregate meal setting (Title III C1 and C2).
The study will compare the usual care process with no referral to the new model which includes a referral and nutrition care in the community using a stepped wedge cluster-randomized trial design.12 All participating sites will start in the control condition (usual process/care) and then be randomized to unidirectionally crossover to the intervention condition within four sequence blocks on a staggered schedule (see work plan year 2 for detailed table). Patients diagnosed with malnutrition in the hospital setting will be cross-sectionally identified and enrolled within each study period. All enrolled patients, regardless of whether they are in the control or receive the intervention will have outcome measures collected 3 months post-discharge (+/- two weeks). All sites will begin in the control period and then two sites at a time will implement the intervention in a staggered approach. Thus, in period 1 all are following usual care, then in period 2, two sites will implement the new model, in period 3, two additional sites will implement it, and this will continue until all sites have implemented the new model (intervention) at the end of period 5. Each period will last 7 months for a total study duration of 35 months. Patient recruitment will occur within all 5 periods for a total of 1120 patients and at a rate of approximately six to seven patients per month per site. This approach ensures all sites test the intervention and evaluate sustainability and impact of the new model.
Clinical setting: Standards for usual care within the hospital includes screening for malnutrition risk by nursing or other non-RDN staff, 14 within 24 hours of admission. A positive screening elicits a consultation with an RDN who conducts a comprehensive assessment to determine whether a nutrition problem, such as malnutrition, exists. The RDN will then provide nutrition care to patients for the duration of their hospital stay. The nutrition care is documented in the hospital's electronic health record (EHR) and includes anthropometric and laboratory data in addition to the nutrition problem and care plan.For the new model of care, the data collection tool (ANDHII) will be modified to use the HL7® FHIR standard to import (pull) data from acute care hospital EHRs. The data will then be available via ANDHII for the community RDN to use.
Community setting: Within our new model of continuity of nutrition care, an RDN within the meal provision organization (Title III-C1 and 2) will log into ANDHII and accept the referral and subsequent data sent by the clinical RDN. The community RDN will review the data and the discharge nutrition care plan before visiting with the patient within their home or at the congregate meal center. At the initial community visit (home visit or congregate meal site), the community RDN will reassess the person for malnutrition and adjust the nutrition care plan as needed for the home/community environment and the patient's social, functional, and economic circumstances. The aim within the community setting will be for the community RDN to have three subsequent visits, approximately a month apart, for three months post-discharge from the hospital. A dedicated Research RDN at each site will conduct the malnutrition, food security, and QOL tools at baseline and again at the end of month three post-discharge for all the enrolled patients, regardless of whether they are in the control or intervention period.
- Conditions
- Malnutrition; Protein
- Being tested
- Nutrition care by RDN, medical nutrition therapy -stepped wedge cluster-randomized trial design. Everyone gets the intervention so no arms.
- Medical subject headings
- Kwashiorkor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition care by RDN, medical nutrition therapy -stepped wedge cluster-randomized trial design. Everyone gets the intervention so no arms.Dietary supplement
Also called Meals
RDNs in the community will provide MNT and meals for three months post discharge from the hospital
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life Scale (CASP-19)
This tool has been validated in older populations and examined in populations with lower socioeconomic status and in different racial and ethnic populations. It will be conducted to evaluate the change in quality of life over time as a result of the intervention.
Measured: 3 months
Secondary outcomes (6)
Program Sustainability Assessment Tool
The Program Sustainability Assessment Tool (PSAT) is based on a sustainability framework with eight domains (environmental support, financial stability, communications, strategic planning, partnerships, program adaptation, program evaluation, organizational capacity). Each of these domains provides insight into the program's sustainability and opportunities for enhancement. The assessment tool has 40 questions within the eight domains and will be completed by the research RDN. It takes approximately 10-15 mins to complete and thus has minimal staff burden.
Measured: Facility level outcome, thus outcome will be done at study completion for the site years 2 through 4
RDN Survey on Barriers and Facilitators to Implementation
A survey which has been developed and used within Academy research projects, will be modified to assess this new model.
Measured: Facility level outcome, thus outcome will be done at study completion for the site years 2 through 4
Change in percent of patients receiving nutrition care and meals
Pre and post numbers of patients who have malnutrition and are referred from the acute care setting to the community setting receiving care by an RDN and meals from meal provision title III-C1 and C2 funded organizations will be captured and calculated for a percent change from the control period to post implementation of the new model
Measured: 3 months
Food Security Risk
The food security risk assessment tool is valid has 6 questions and will be used to determine security risk.
Measured: 3 months post discharge from the hospital
Malnutrition risk
The malnutrition screening tool is a valid tool for determining risk of malnutrition in adults.
Measured: baseline in hospital and at 3 months post discharge from the hospital
Malnutrition Diagnosis (AAIM tool)
Validated diagnostic tool for moderate and severe malnutrition in adults.
Measured: 3 months post discharge from the hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start1 Jan 2024 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malnutrition; ProteinStudies 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
- Sequential
- Model description
- Patient enrollment and data collection will begin in year two. In year one, sites will have been randomized to the intervention condition within four sequence blocks on a staggered schedule. The stepped wedge cluster-randomized trial design will go through 5 periods with each period lasting for 7 months for a total of 35 months (year 2 through year 4). The goal of year two is for all sites to initiate the schedule to which they are randomly assigned. All participating sites will start in the control condition (usual process/care) in period 1. By the end of year two, we aim for sites to be within period 2. At this time, two sites will be implementing the intervention. Patients will be recruited and enrolled from acute care hospital sites in a rolling fashion across the entire study period (year 2 to year 4).
- Masking
- None (open label)
- Enrolment
- 1,120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Academy of Nutrition and Dietetics
- Sponsor type
- University, hospital or other
- Collaborators
- University of New Mexico, Hartford Hospital, Meals on Wheels Central Texas
- Responsible party
- Principal investigator, Alison L Steiber, Academy of Nutrition and Dietetics
- Investigators
- Alison L Steiber, Principal investigator, Academy of Nutrition and Dietetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05893446
- Sponsor's protocol ID
- 95INNU0045
- Status last verified
- Jun 2023
- First submitted
- 19 May 2023
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Essential Connections: How Improved Referrals From Hospital to Community Meal Provision Can Impact Malnutrition Outcomes in Older Adults
- ClinicalTrials.gov ID
- NCT05893446
- Acronym / sponsor ID
- 95INNU0045
- Conditions
- Malnutrition; Protein
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,120 participants (estimated)
- Lead sponsor
- Academy of Nutrition and DieteticsUniversity, hospital or other
- Collaborators
- University of New Mexico, Hartford Hospital, Meals on Wheels Central Texas
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 8 Jun 2023 (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.
Meal provision organizations, whether they provide meals within the home or in congregate centers, provide an excellent opportunity to address malnutrition by providing nutrition care and meals to those who are most vulnerable. Data has shown that nutrition care within the home by a dietitian can increase energy, protein intake, and body weight. The goal of this study is to test a new model for continuity of nutrition care for malnutrition treatment across settings and determine if it improves food security and quality of life in patients 60 years and older. The study will specifically recruit sites and a sample that represents individuals who have malnutrition, have experienced or are at risk for food insecurity, and those from rural areas as well as Black, Latino, Indigenous and Native American populations with a goal sample size of 1,120 patients over the five-year duration. The objectives of this study are to: 1) test the feasibility of a patient identification, cross-referral, data reporting, and communication process from an acute care hospital to a community meal provision organization; 2) identify barriers to and facilitators for implementation as well as costs of the new model of continuity of nutrition care across settings; and 3) improve food security, determinants of malnutrition, and quality of life in persons older than 60 years of age discharged from the hospital with a diagnosis of malnutrition. Level 1 evidence will be generated from the study. The outcomes to be measured are program sustainability, percent change in referrals, food insecurity, malnutrition risk and diagnosis, and quality of life. The results of this study can provide a new model for nutrition care that may improve food security, quality of life, and health outcomes.
Detailed description
We hypothesize that enhanced continuity of nutrition care between acute care hospital settings and community meal provision organizations providing Title III-C Special Need Plan services (C1 and C2) will be sustainable and improve outcomes for patients older than 60 years of age who are diagnosed with malnutrition. Specifically, the enhanced continuity of care will: a) increase referrals and communication between clinical and community nutrition care providers at each study site location; b) increase the percent of patients receiving nutrition care within the community setting; and c) improve food security, quality of life, and reduce determinants of malnutrition.
To test this hypothesis, we propose to conduct a study which will examine a new model of continuity of nutrition care for sustainability and impact. The model has been developed to facilitate cross-referrals and transmission of structured nutrition care documentation from an acute care setting to a meal provision organization and then for the meal provision organization to use the referral data to increase delivery of nutrition care (medical nutrition therapy- MNT) and meals (medically tailored meals - MTM). The primary subjects for this study are adults older than 60 years of age with malnutrition, with particular emphasis on recruiting sites who serve individuals who are Black, Latino, Indigenous and Native Americans and individuals living in rural areas of the country.
The components of the proposed new model of cross-referral, data transfer, and nutrition care across settings has the potential to be scalable throughout the US. However, barriers and facilitators to data transfer and MNT/MTM provision, cost of implementation, and potential impact on outcomes must be evaluated for the model to be replicable. The results of this study will generate new data on the model of care feasibility, rates of malnutrition within older adults at the study sites, impact of MNT with MTM provision on food security, determinants of malnutrition, and quality of life to inform future scalability of the model.
Goals and Objectives The goal of this new model is to improve food security and quality of life in patients 60 years and older from key vulnerable populations with greatest social and economic need by providing continuity of nutrition care for malnutrition treatment across settings. To test the feasibility of this new model, we will use a stepped wedge cluster-randomized trial design at eight sites throughout the US, specifically recruiting sites and individuals who are Black, Latino, Indigenous and Native American, and individuals living in rural areas of the country. The Academy of Nutrition and Dietetics (the Academy), as the research organization, and the Academy of Nutrition and Dietetics Foundation (Academy Foundation) will partner with collaborating organizations in both acute care hospitals and meal provision organizations (Title III-C1 and C2) within the community to test the newly developed model.
Objective 1) To test the feasibility of a patient identification, cross-referral, data reporting, and communication (including data transfer) process from an acute care hospital to a community meal provision organization.
Objective 1a) To identify barriers to and facilitators for implementation as well as the cost of the new model of continuity of nutrition care across settings.
Objective 2) To increase the rate of patients older than 60 years of age with malnutrition receiving care (MNT, MTM) in the community setting.
Objective 3) To improve food security, determinants of malnutrition, and quality of life in persons older than 60 years of age discharged from the hospital with a diagnosis of malnutrition.
There are two distinct portions of the study intervention: the clinical component, which includes patient identification, effective cross-referrals, and enhanced data reporting and transfer to the community partner, and the community component, including enhanced nutrition care and reporting including both MNT and MTM. The meals and nutrition care within the community can occur at home or within a congregate meal setting (Title III C1 and C2).
The study will compare the usual care process with no referral to the new model which includes a referral and nutrition care in the community using a stepped wedge cluster-randomized trial design.12 All participating sites will start in the control condition (usual process/care) and then be randomized to unidirectionally crossover to the intervention condition within four sequence blocks on a staggered schedule (see work plan year 2 for detailed table). Patients diagnosed with malnutrition in the hospital setting will be cross-sectionally identified and enrolled within each study period. All enrolled patients, regardless of whether they are in the control or receive the intervention will have outcome measures collected 3 months post-discharge (+/- two weeks). All sites will begin in the control period and then two sites at a time will implement the intervention in a staggered approach. Thus, in period 1 all are following usual care, then in period 2, two sites will implement the new model, in period 3, two additional sites will implement it, and this will continue until all sites have implemented the new model (intervention) at the end of period 5. Each period will last 7 months for a total study duration of 35 months. Patient recruitment will occur within all 5 periods for a total of 1120 patients and at a rate of approximately six to seven patients per month per site. This approach ensures all sites test the intervention and evaluate sustainability and impact of the new model.
Clinical setting: Standards for usual care within the hospital includes screening for malnutrition risk by nursing or other non-RDN staff, 14 within 24 hours of admission. A positive screening elicits a consultation with an RDN who conducts a comprehensive assessment to determine whether a nutrition problem, such as malnutrition, exists. The RDN will then provide nutrition care to patients for the duration of their hospital stay. The nutrition care is documented in the hospital's electronic health record (EHR) and includes anthropometric and laboratory data in addition to the nutrition problem and care plan.For the new model of care, the data collection tool (ANDHII) will be modified to use the HL7® FHIR standard to import (pull) data from acute care hospital EHRs. The data will then be available via ANDHII for the community RDN to use.
Community setting: Within our new model of continuity of nutrition care, an RDN within the meal provision organization (Title III-C1 and 2) will log into ANDHII and accept the referral and subsequent data sent by the clinical RDN. The community RDN will review the data and the discharge nutrition care plan before visiting with the patient within their home or at the congregate meal center. At the initial community visit (home visit or congregate meal site), the community RDN will reassess the person for malnutrition and adjust the nutrition care plan as needed for the home/community environment and the patient's social, functional, and economic circumstances. The aim within the community setting will be for the community RDN to have three subsequent visits, approximately a month apart, for three months post-discharge from the hospital. A dedicated Research RDN at each site will conduct the malnutrition, food security, and QOL tools at baseline and again at the end of month three post-discharge for all the enrolled patients, regardless of whether they are in the control or intervention period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Model description
- Patient enrollment and data collection will begin in year two. In year one, sites will have been randomized to the intervention condition within four sequence blocks on a staggered schedule. The stepped wedge cluster-randomized trial design will go through 5 periods with each period lasting for 7 months for a total of 35 months (year 2 through year 4). The goal of year two is for all sites to initiate the schedule to which they are randomly assigned. All participating sites will start in the control condition (usual process/care) in period 1. By the end of year two, we aim for sites to be within period 2. At this time, two sites will be implementing the intervention. Patients will be recruited and enrolled from acute care hospital sites in a rolling fashion across the entire study period (year 2 to year 4).
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- English or Spanish speaking,
- Screened as at risk for malnutrition (Malnutrition Screening Tool),
- Meet the definition for food insecure per the Food Security Risk tool,
- Referred to an RDN,
- Diagnosed with malnutrition using AAIM,
Key exclusion criteria (2 listed)
- Patients are receiving hospice care or care for end stage cancer,
- Unable to consume meals (e.g., using enteral or parenteral to meet nutrition needs), Do not live within the meal provision organizations catchment.
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 |
|---|---|---|
| Nutrition care by RDN, medical nutrition therapy -stepped wedge cluster-randomized trial design. Everyone gets the intervention so no arms.Also: MealsRDNs in the community will provide MNT and meals for three months post discharge from the hospital | Dietary supplement | – |
Primary outcome
Quality of Life Scale (CASP-19)
Time frame: 3 months
This tool has been validated in older populations and examined in populations with lower socioeconomic status and in different racial and ethnic populations. It will be conducted to evaluate the change in quality of life over time as a result of the intervention.
6 secondary outcomes
Program Sustainability Assessment Tool
Time frame: Facility level outcome, thus outcome will be done at study completion for the site years 2 through 4
RDN Survey on Barriers and Facilitators to Implementation
Time frame: Facility level outcome, thus outcome will be done at study completion for the site years 2 through 4
Change in percent of patients receiving nutrition care and meals
Time frame: 3 months
Food Security Risk
Time frame: 3 months post discharge from the hospital
Malnutrition risk
Time frame: baseline in hospital and at 3 months post discharge from the hospital
Malnutrition Diagnosis (AAIM tool)
Time frame: 3 months post discharge from the hospital
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 8 Jun 2023.
- Individual participant dataSharing planned: No
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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.
Alison L Steiber principal investigator
Academy of Nutrition and Dietetics
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition care by RDN, medical nutrition therapy -stepped wedge cluster-randomized trial design. Everyone gets the intervention so no arms. in people with Malnutrition; Protein, run by Academy of Nutrition and Dietetics.
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 7 inclusion and 2 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 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Lindsay Woodstock, PhD (3128994797, lwoodstock@eatright.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life Scale (CASP-19) (time frame: 3 months). 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 8 Jun 2023.