Alzheimer Disease and Related DementiasPPCINCT05618834
Promoting Positive Care Interactions (PPCI) in Assisted Living
A study testing Promoting Positive Care Interactions (PPCI) and PPCI-Staff Education Only (EO) in people with Alzheimer Disease and Related Dementias, run by Penn State University at 1 site in United States.
Trial summary
The overall aim of this study is to pilot test Promoting Positive Care Interactions (PPCI) with the goal of establishing a feasible and culturally responsive approach to optimize care interactions between staff (nursing, activity, housekeeping, and dining service staff) and residents with ADRD in assisted living… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Alzheimer Disease and Related Dementias
- What is being tested?
- Promoting Positive Care Interactions (PPCI) and PPCI-Staff Education Only (EO)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2025to 11 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Assisted Living Facility (ALF) will be included in the study if they:
- have at least 20 or more beds
- are able to identify a facility champion, and
- express a willingness to actively partner in an initiative to change practice at their institution
- Staff will be included in the study if they:
- are able to communicate in English, and
Show all 11Show fewer
- work at least 16 hours a week at the facility at the time of recruitment in nursing, activities, housekeeping, or dining service roles
- Residents will be included in the study if they:
- are 65 years old or greater
- are living at the facility at the time of recruitment, and
- have a diagnosis of ADRD and Saint Louis University Mental Status Exam (SLUMS) score of 20 or less (high school education)/ 19 or less (less than high school education) suggesting ADRD
Who cannot join
- Assisted Living Facility (ALF) will be excluded from the study if they:
- have less than 20 beds
- are unable to identify a facility champion, and
- do not express a willingness to actively partner in an initiative to change practice at their institution
- Staff will be included in the study if they:
- are unable to communicate in English, and
Show all 11Show fewer
- work less than16 hours a week at the facility at the time of recruitment in nursing, activities, housekeeping, or dining service roles
- Residents will be included in the study if they:
- are less than 65 years old
- are not living at the facility at the time of recruitment, and
- do not have a diagnosis of ADRD and Saint Louis University Mental Status Exam (SLUMS) score of 20 or less (high school education)/ 19 or less (less than high school education) suggesting ADRD
Trial locations and contacts
1 site in 1 country.
United States1 site
The Pennsylvania State University
University Park, Pennsylvania, 16802
About this study
Official title: Optimizing Daily Care Interactions Between Staff and Assisted Living Residents With Alzheimer's Disease and Related Dementias
The overall aim of this study is to pilot test Promoting Positive Care Interactions (PPCI) with the goal of establishing a feasible and culturally responsive approach to optimize care interactions between staff (nursing, activity, housekeeping, and dining service staff) and residents with ADRD in assisted living facilities (ALFs), and further improve select resident, staff, and facility outcomes. PPCI is a non- pharmacological four-step approach consisting of (1) stakeholder engagement in developing facility specific goals; (2) environment and policy assessments; (3) flexible staff education; and (4) ongoing mentorship, motivation, and support (in-person visits and text messages) for staff to optimize care interactions.
Read the detailed description
Nearly one million individuals living in 28,900 assisted living facilities (ALFs) in the U.S. participate in daily care interactions, defined as any verbal or nonverbal exchange between staff and residents during physical and social care activities. While there are positive care interactions, poor care interactions also persist with prevalence as high as 25% in long-term care including ALFs. Individuals with Alzheimer's disease and related dementias (ADRD) are especially at risk for poor care interactions due to ineffective staff approaches such as negative touching (e.g., quickly removing clothes to bathe a resident), being overprotective (e.g., restricting activity for safety concerns), and lack of verbal or non-verbal contact during care. Persistent poor care interactions can negatively affect both residents and staff. Thus, there is a need to replace poor care interactions with positive care interactions, now more than ever given the worsening staff retention related to COVID-19 pandemic, and constant need to train new employees.
Positive care interaction refers to care interactions where staff use positive approaches such as honoring resident's abilities and preferences, recognizing resident's responses/non-verbal cues, acknowledging resident's effort, providing role modeling and verbal cues, managing self-responses, and using a calm respectful approach for appropriate delivery of care. It has been long known that use of positive approaches benefits both residents (e.g., less behavioral distress) and staff (e.g., greater competence in care). Yet, poor interactions continue in ALFs due to interlocking barriers associated with residents' ADRD-related communication and other difficulties and behaviors of distress (e.g., agitation), as well as staff's knowledge and training deficits in ADRD care; ALFs have fewer licensing and training mandates for staff. Lack of cultural concordance can also contribute to poor interactions. The ALF staff, often younger (mean age=38.3 yrs.) females (83.8%) with almost half representing racial minorities (47.6%) care for largely non-Hispanic white (81.4%) resident population >=65 years (93.4%). Additionally, there are systemic barriers including limited organizational engagement in implementing and sustaining these approaches, lack of environmental infrastructure (e.g., controlled noise and availability of augmentative devices such as pocket talker) and policies (e.g., consistent assignments) to support positive care interactions, and lack of adequate mentoring and support for staff. It is crucial to address these issues and barriers and train ALF staff on positive care interactions, particularly since prior work has targeted nursing homes and focused on social interactions or verbal communication.
Therefore, this study proposes Promoting Positive Care Interactions (PPCI), a four-step approach, based on Social Ecological Model (SEM) and Social Cognitive Theory (SCT), to optimize daily care interactions between staff and residents with ADRD in ALFs. The four steps include: 1) stakeholder engagement in developing facility specific goals; (2) environment and policy assessments; (3) flexible staff education; and (4) ongoing mentorship, motivation, and support (in-person visits and text messages) for staff to optimize care interactions. These four steps are based on prior work implementing function \& behavior focused intervention studies but have never been used in a care interaction-focused intervention nor been tested for cultural responsiveness. This study will follow a cluster randomized trial in a sample of 60 residents and 60 staff in four ALFs in central PA (approx. 15 residents, 15 staff/ALF) who agree and consent to participate in this study. The treatment group will receive all four steps of PPCI while the control arm will receive education only.
- Conditions
- Alzheimer Disease and Related Dementias
- Being tested
- Promoting Positive Care Interactions (PPCI), PPCI-Staff Education Only (EO)
- Keywords
- Dementia, Care Interactions, Communication, Assisted Living, Long-Term Care
- Medical subject headings
- Alzheimer Disease, Dementia, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Promoting Positive Care Interactions (PPCI)Behavioural
The PPCI consists of four steps: (1) stakeholder engagement in developing facility specific goals; (2) environment and policy assessments; (3) flexible staff education; and (4) ongoing mentorship, motivation, and support (in-person visits and text messages) for staff to optimize care interactions.
A research nurse facilitator (RNF), a registered nurse (RN) with prior experience in long-term care will work with an identified internal champion monthly to implement the four steps of PPCI. The PPCI intervention comprehensively focuses on intrapersonal, interpersonal, organizational, and environmental/policy factors to bring together evidence and key stakeholders to optimize daily care interactions in assisted living.
PPCI-Staff Education Only (EO)Behavioural
The EO will include a 30-45 min in-service session and monthly f/u visits for booster education. The education content and process will be the same as outlined in Step 3 of the PPCI for treatment sites.
| Study group | Role | What they receive |
|---|---|---|
| PPCI Arm | Experimental | The ALF/PCH assigned as treatments will receive the four steps of PPCI including, stakeholder engagement and facility goal development, environment and policy assessment, staff education, and ongoing mentorship/motivation and support over a period of six-months by a research nurse facilitator (RNF), a registered nurse (RN) with prior experience in long-term care. The RNF will work with an identified internal/facility champion monthly to implement the four steps of PPCI. Receives: Behavioral: Promoting Positive Care Interactions (PPCI) |
| PPCI-Staff Education Only Arm | Active comparator | The ALF/PCH assigned as controls will receive PPCI-staff education only (EO). The EO will include a 30-45 min in-service session and monthly f/u visits for booster education. The education content and process will be the same as outlined in Step 3 of the PPCI for treatment sites. Receives: Behavioral: PPCI-Staff Education Only (EO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The degree to which the intervention can be implemented as intended assessed by Feasibility of Intervention Measure (FIM) Questionnaire
4 items answered on a 5-point ordinal scale ranging from 'completely disagree' to 'completely agree'; range = 4 to 20 and higher scores are better
Measured: six-months post intervention
The degree to which the intervention is acceptable assessed by Acceptability of Intervention Measure (AIM) Questionnaire
4 items answered on a 5-point ordinal scale ranging from 'completely disagree' to 'completely agree'; range = 4 to 20 and higher scores are better
Measured: six-months post intervention
Secondary outcomes (10)
Well-being assessed by Quality of Life in Late-stage Dementia (QUALID) Scale
11 items on a 5-point scale, range = 11 to 55 and higher scores are better
Measured: baseline and 6 months
Level of agitation assessed by Cohen-Mansfield Agitation Inventory (CMAI-short form)
14 items answered on a 5-point scale, range = 14 to 70 and lower scores are better
Measured: baseline and 6 months
Frequency and intensity of resistive behaviors assessed by Resistiveness to Care (RTC) Scale
13 items answered on a 3-point scale for intensity and a number provided for frequency, range = 13 to 39 for intensity and lower scores are better
Measured: baseline and 6 months
Knowledge of person-centered behavioral approaches for managing behavioral symptoms of distress assessed by Knowledge of Person-Centered Behavioral Approaches for BPSD
10 items with four responses (1 correct, 3 distracters), range = 0 to 10 and higher scores are better
Measured: baseline and 6 months
Perceived competence in dementia care assessed by Sense of Competence in Dementia Care Staff (SCIDS)
17 items on a 4-point scale, range = 17 to 68 and higher scores are better
Measured: baseline and 6 months
Level of stress assessed by Health Professions Stress Inventory (HPSI)
12 items on a 5-point scale, range = 0 to 48 and lower scores are better
Measured: baseline and 6 months
Staff-resident relationship quality assessed by Positive Affect Index (PAI)
5 items on a 6-point scale, range = 5 to 30 and higher scores are better
Measured: baseline and 6 months
Staff-resident care interactions assessed by Quality of Care Interactions Schedule (QuIS)
5 items answered on a 3-point scale, range = 0 to 7 and higher scores are better
Measured: baseline and 6 months
Provision of facility policies pertaining to promoting positive care interactions (PPCI) assessed by Assessment of Policies for PPCI
24 items answered as yes (1) or no (0), range = 0 to 24 and higher scores are better
Measured: baseline and 6 months
Provision of facility environment pertaining to promoting positive care interactions (PPCI) assessed by Assessment of Environment for PPCI
23 items answered as yes (1) or no (0), range = 0 to 23 and higher scores are better
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start3 Mar 2025
- Primary completion8 Dec 2025
- Study completion11 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer Disease and Related DementiasStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anju Paudel, PhD, MGS, RN, Penn State University
- Investigators
- Anju Paudel, Assistant Professor, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05618834
- Sponsor's protocol ID
- STUDY00021256
- Acronym
- PPCI
- Status last verified
- Aug 2025
- First submitted
- 31 Oct 2022
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Daily Care Interactions Between Staff and Assisted Living Residents With Alzheimer's Disease and Related Dementias
- ClinicalTrials.gov ID
- NCT05618834
- Acronym / sponsor ID
- PPCI / STUDY00021256
- Conditions
- Alzheimer Disease and Related Dementias
- Keywords
- Dementia, Care Interactions, Communication, Assisted Living, Long-Term Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 8 Dec 2025 (actual)
- Study completion
- 11 Mar 2026 (actual)
- First posted
- 16 Nov 2022 (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 overall aim of this study is to pilot test Promoting Positive Care Interactions (PPCI) with the goal of establishing a feasible and culturally responsive approach to optimize care interactions between staff (nursing, activity, housekeeping, and dining service staff) and residents with ADRD in assisted living facilities (ALFs), and further improve select resident, staff, and facility outcomes. PPCI is a non- pharmacological four-step approach consisting of (1) stakeholder engagement in developing facility specific goals; (2) environment and policy assessments; (3) flexible staff education; and (4) ongoing mentorship, motivation, and support (in-person visits and text messages) for staff to optimize care interactions.
Detailed description
Nearly one million individuals living in 28,900 assisted living facilities (ALFs) in the U.S. participate in daily care interactions, defined as any verbal or nonverbal exchange between staff and residents during physical and social care activities. While there are positive care interactions, poor care interactions also persist with prevalence as high as 25% in long-term care including ALFs. Individuals with Alzheimer's disease and related dementias (ADRD) are especially at risk for poor care interactions due to ineffective staff approaches such as negative touching (e.g., quickly removing clothes to bathe a resident), being overprotective (e.g., restricting activity for safety concerns), and lack of verbal or non-verbal contact during care. Persistent poor care interactions can negatively affect both residents and staff. Thus, there is a need to replace poor care interactions with positive care interactions, now more than ever given the worsening staff retention related to COVID-19 pandemic, and constant need to train new employees.
Positive care interaction refers to care interactions where staff use positive approaches such as honoring resident's abilities and preferences, recognizing resident's responses/non-verbal cues, acknowledging resident's effort, providing role modeling and verbal cues, managing self-responses, and using a calm respectful approach for appropriate delivery of care. It has been long known that use of positive approaches benefits both residents (e.g., less behavioral distress) and staff (e.g., greater competence in care). Yet, poor interactions continue in ALFs due to interlocking barriers associated with residents' ADRD-related communication and other difficulties and behaviors of distress (e.g., agitation), as well as staff's knowledge and training deficits in ADRD care; ALFs have fewer licensing and training mandates for staff. Lack of cultural concordance can also contribute to poor interactions. The ALF staff, often younger (mean age=38.3 yrs.) females (83.8%) with almost half representing racial minorities (47.6%) care for largely non-Hispanic white (81.4%) resident population >=65 years (93.4%). Additionally, there are systemic barriers including limited organizational engagement in implementing and sustaining these approaches, lack of environmental infrastructure (e.g., controlled noise and availability of augmentative devices such as pocket talker) and policies (e.g., consistent assignments) to support positive care interactions, and lack of adequate mentoring and support for staff. It is crucial to address these issues and barriers and train ALF staff on positive care interactions, particularly since prior work has targeted nursing homes and focused on social interactions or verbal communication.
Therefore, this study proposes Promoting Positive Care Interactions (PPCI), a four-step approach, based on Social Ecological Model (SEM) and Social Cognitive Theory (SCT), to optimize daily care interactions between staff and residents with ADRD in ALFs. The four steps include: 1) stakeholder engagement in developing facility specific goals; (2) environment and policy assessments; (3) flexible staff education; and (4) ongoing mentorship, motivation, and support (in-person visits and text messages) for staff to optimize care interactions. These four steps are based on prior work implementing function \& behavior focused intervention studies but have never been used in a care interaction-focused intervention nor been tested for cultural responsiveness. This study will follow a cluster randomized trial in a sample of 60 residents and 60 staff in four ALFs in central PA (approx. 15 residents, 15 staff/ALF) who agree and consent to participate in this study. The treatment group will receive all four steps of PPCI while the control arm will receive education only.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PPCI Arm | Experimental | Behavioral: Promoting Positive Care Interactions (PPCI)The ALF/PCH assigned as treatments will receive the four steps of PPCI including, stakeholder engagement and facility goal development, environment and policy assessment, staff education, and ongoing mentorship/motivation and support over a period of six-months by a research nurse facilitator (RNF), a registered nurse (RN) with prior experience in long-term care. The RNF will work with an identified internal/facility champion monthly to implement the four steps of PPCI. |
| PPCI-Staff Education Only Arm | Active comparator | Behavioral: PPCI-Staff Education Only (EO)The ALF/PCH assigned as controls will receive PPCI-staff education only (EO). The EO will include a 30-45 min in-service session and monthly f/u visits for booster education. The education content and process will be the same as outlined in Step 3 of the PPCI for treatment sites. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- have at least 20 or more beds
- are able to identify a facility champion, and
- express a willingness to actively partner in an initiative to change practice at their institution
- are able to communicate in English, and
- work at least 16 hours a week at the facility at the time of recruitment in nursing, activities, housekeeping, or dining service roles
Key exclusion criteria (11 listed)
- have less than 20 beds
- are unable to identify a facility champion, and
- do not express a willingness to actively partner in an initiative to change practice at their institution
- are unable to communicate in English, and
- work less than16 hours a week at the facility at the time of recruitment in nursing, activities, housekeeping, or dining service roles
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 |
|---|---|---|
| Promoting Positive Care Interactions (PPCI)The PPCI consists of four steps: (1) stakeholder engagement in developing facility specific goals; (2) environment and policy assessments; (3) flexible staff education; and (4) ongoing mentorship, motivation, and support (in-person visits and text messages) for staff to optimize care interactions. A research nurse facilitator (RNF), a registered nurse (RN) with prior experience in long-term care will work with an identified internal champion monthly to implement the four steps of PPCI. The PPCI intervention comprehensively focuses on intrapersonal, interpersonal, organizational, and environmental/policy factors to bring together evidence and key stakeholders to optimize daily care interactions in assisted living. | Behavioural | PPCI Arm |
| PPCI-Staff Education Only (EO)The EO will include a 30-45 min in-service session and monthly f/u visits for booster education. The education content and process will be the same as outlined in Step 3 of the PPCI for treatment sites. | Behavioural | PPCI-Staff Education Only Arm |
Primary outcome
The degree to which the intervention can be implemented as intended assessed by Feasibility of Intervention Measure (FIM) Questionnaire
Time frame: six-months post intervention
4 items answered on a 5-point ordinal scale ranging from 'completely disagree' to 'completely agree'; range = 4 to 20 and higher scores are better
The degree to which the intervention is acceptable assessed by Acceptability of Intervention Measure (AIM) Questionnaire
Time frame: six-months post intervention
4 items answered on a 5-point ordinal scale ranging from 'completely disagree' to 'completely agree'; range = 4 to 20 and higher scores are better
10 secondary outcomes
Well-being assessed by Quality of Life in Late-stage Dementia (QUALID) Scale
Time frame: baseline and 6 months
Level of agitation assessed by Cohen-Mansfield Agitation Inventory (CMAI-short form)
Time frame: baseline and 6 months
Frequency and intensity of resistive behaviors assessed by Resistiveness to Care (RTC) Scale
Time frame: baseline and 6 months
Knowledge of person-centered behavioral approaches for managing behavioral symptoms of distress assessed by Knowledge of Person-Centered Behavioral Approaches for BPSD
Time frame: baseline and 6 months
Perceived competence in dementia care assessed by Sense of Competence in Dementia Care Staff (SCIDS)
Time frame: baseline and 6 months
Level of stress assessed by Health Professions Stress Inventory (HPSI)
Time frame: baseline and 6 months
Staff-resident relationship quality assessed by Positive Affect Index (PAI)
Time frame: baseline and 6 months
Staff-resident care interactions assessed by Quality of Care Interactions Schedule (QuIS)
Time frame: baseline and 6 months
Provision of facility policies pertaining to promoting positive care interactions (PPCI) assessed by Assessment of Policies for PPCI
Time frame: baseline and 6 months
Provision of facility environment pertaining to promoting positive care interactions (PPCI) assessed by Assessment of Environment for PPCI
Time frame: baseline and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Alzheimer Disease and Related Dementias
Active, not recruitingPhase 2
A Study to Evaluate the Safety and Biomarker Effects of RO7269162 in Participants at Risk for or at the Prodromal Stage of Alzheimer's Disease (AD)
Alzheimer's Disease
RecruitingPhase 3
Nabilone for Agitation Blinded Intervention Trial
Alzheimer Disease, Agitation
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
Not yet recruiting
Music Listening for Chronic Pain in Adults With Early-Stage Dementia
Chronic Pain, Alzheimer Disease
Not yet recruiting
A Mobile Informatics Solution to Assist Caregivers in Care Coordination and Monitoring Social Engagement
Memory Disorders, Mild Cognitive Impairment
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.
Anju Paudel, Assistant Professor principal investigator
Penn State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Promoting Positive Care Interactions (PPCI) and PPCI-Staff Education Only (EO) in people with Alzheimer Disease and Related Dementias, run by Penn State University 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 11 inclusion and 11 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: finished, as of the sponsor's last update on 27 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The degree to which the intervention can be implemented as intended assessed by Feasibility of Intervention Measure (FIM) Questionnaire (time frame: six-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 27 Apr 2026.