Registered outcomes18

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 18 of 18

List	Outcome	Time frame	Description
Primary	Recruitment feasibility and recruitment rate	From start of recruitment through completion of enrollment, anticipated up to approximately 14 months	Recruitment flow will be summarized using the numbers and proportions of potentially eligible individuals identified or referred, proceeding to informed consent, meeting formal eligibility criteria, and enrolling. Recruitment rate will be calculated as the number of formally eligible individuals enrolled divided by the total number of formally eligible individuals.
Primary	Participant retention rate	From enrollment through the planned end-of-study timepoint, up to approximately 7 weeks per participant	Participant retention rate will be calculated as the proportion of enrolled participants who remain in study follow-up through the planned end-of-study timepoint, whether or not they complete all planned regular VR sessions. Completion of an end-of-study or early-termination assessment will be measured separately.
Primary	Intervention initiation rate	From enrollment through the first regular VR intervention session or determination of non-initiation, anticipated within approximately 2 weeks per participant	Intervention initiation rate will be calculated as the proportion of enrolled participants who initiate at least one regular VR intervention session. Familiarization or orientation will not constitute intervention initiation.
Primary	Intervention adherence and session completion	During the VR intervention period, up to approximately 6 weeks	Intervention adherence will be calculated among participants who initiate at least one regular VR intervention session as the number of participant-specific planned regular VR sessions completed as tolerated divided by the total number of participant-specific planned regular VR sessions. Participants may have up to 18 planned regular VR sessions over up to six weeks. Familiarization will be excluded from the adherence calculation.
Primary	Session-delivery feasibility	During the VR intervention period, up to approximately 6 weeks	Prospectively planned regular VR sessions that are offered but not initiated, stopped early, deferred, or not conducted will be summarized by frequency and reason. Reasons may include participant refusal or unavailability, clinical or safety considerations, discharge or transfer, medication-related timing, staffing or workflow limitations, infection-prevention requirements, or device and technical problems.
Primary	Intervention completion and disposition	From enrollment through end-of-study or early termination, up to approximately 7 weeks per participant	The numbers and proportions of enrolled participants who complete the planned VR intervention period, permanently discontinue VR before the planned end of the intervention period, or terminate study participation early will be summarized, together with the reasons.
Primary	Intervention tolerability	During the VR intervention period, up to approximately 6 weeks	Intervention tolerability will be summarized using the number and proportion of regular VR sessions associated with intolerance or early stopping, the types and outcomes of tolerability events, and the number and proportion of intervention-exposed participants who permanently discontinue VR because of VR-related intolerance or adverse effects.
Primary	Safety and session-level tolerability events	From informed consent through end-of-study or early termination, up to approximately 7 weeks per enrolled participant	Adverse events and serious adverse events will be summarized by frequency, type, severity, seriousness, relationship to VR or study procedures, action taken, and outcome. Session-level intolerance or tolerability events and other safety concerns associated with VR exposure or study participation will also be summarized descriptively.
Primary	Staff acceptability, appropriateness, usability, implementation feasibility, perceived workload and workflow burden, and workflow integration	From completion of facilitator training/orientation through the end of relevant staff involvement or intervention delivery, through study completion, anticipated up to approximately 15 months	Staff implementation outcomes will be assessed through two complementary staff-feedback pathways using three study-specific questionnaires: matched pre- and post-implementation questionnaires for appropriately trained and PI/Site PI-delegated VR facilitators, and a separate one-time questionnaire for eligible frontline care staff with relevant direct experience who are not acting as formal VR facilitators. Outcomes include acceptability, appropriateness, usability, implementation feasibility, perceived benefits and concerns, training and support, workload and workflow fit, barriers, facilitators, sustainability, and recommendations for future implementation.
Primary	Final-assessment completion rate	From enrollment through end-of-study or early termination, up to approximately 7 weeks per participant	Final-assessment completion rate will be calculated as the proportion of enrolled participants who complete an end-of-study or early-termination assessment. This outcome will be reported separately from participant retention.
Other	Change in agitation over time measured by the Cohen-Mansfield Agitation Inventory	Baseline, every 2 weeks during the intervention period, and end-of-study or early termination, up to approximately 7 weeks per participant	Agitation over time will be measured using the Cohen-Mansfield Agitation Inventory (CMAI). The CMAI includes 29 agitated behaviours rated on a 7-point frequency scale. Total scores range from 29 to 203, with higher scores indicating greater frequency of agitated behaviours. Scores will be summarized descriptively to explore changes in agitation from baseline through the intervention period and at end-of-study or early termination.
Other	Change in perceived disruptiveness of agitated behaviours measured using CMAI disruptiveness ratings	Baseline, every 2 weeks during the intervention period, and end-of-study or early termination, up to approximately 7 weeks per participant	Perceived disruptiveness of agitated behaviours will be assessed using CMAI disruptiveness ratings collected alongside the standard CMAI frequency ratings. Disruptiveness reflects how disturbing individual agitated behaviours are perceived to be. Ratings will be summarized separately and descriptively from CMAI frequency ratings to explore changes in the perceived disruptiveness of agitated behaviours over time. CMAI disruptiveness ratings will not be used to determine eligibility.
Other	Immediate pre- to post-session change in agitation measured by the Pittsburgh Agitation Scale	Immediately before and after each regular VR intervention session, as feasible and clinically appropriate, up to 18 sessions over 6 weeks	Immediate within-session change in observed agitation will be measured using the Pittsburgh Agitation Scale, completed immediately before and after each regular VR intervention session, as feasible and clinically appropriate. The PAS assesses observable agitation across four behavioural domains: aberrant vocalization, motor agitation, aggressiveness, and resistance to care. Higher scores indicate greater observed agitation. Scores will be summarized descriptively to explore short-term changes associated with individual regular VR sessions.
Other	Change in behavioural and psychological symptoms measured by the Neuropsychiatric Inventory - Nursing Home Version	Baseline and end-of-study or early termination, up to approximately 7 weeks per participant	Behavioural and psychological symptoms of dementia will be measured using the Neuropsychiatric Inventory - Nursing Home Version (NPI-NH). The NPI-NH assesses neuropsychiatric symptom domains using frequency and severity ratings. Higher scores indicate greater neuropsychiatric symptom burden. Scores will be summarized descriptively to explore changes from baseline to end-of-study or early termination.
Other	Change in NPI-NH occupational disruptiveness ratings	Baseline and end-of-study or early termination, up to approximately 7 weeks per participant	Occupational disruptiveness associated with participants' neuropsychiatric symptoms will be measured using the NPI-NH occupational disruptiveness ratings. Each applicable symptom domain is rated from 0 to 5, with higher ratings indicating greater occupational disruptiveness. Ratings will be summarized descriptively to explore change from baseline to end-of-study or early termination.
Other	Change in quality of life measured by the Quality of Life in Alzheimer's Disease scale, proxy version	Baseline and end-of-study or early termination, up to approximately 7 weeks per participant	Quality of life will be measured using the proxy-rated Quality of Life in Alzheimer's Disease scale (QoL-AD). The standard 13-item version is rated on a 4-point scale, with total scores ranging from 13 to 52. Higher scores indicate better perceived quality of life. Scores will be summarized descriptively to explore changes in proxy-rated quality of life from baseline to end-of-study or early termination.
Other	Change in clinician-rated global agitation severity measured by modified CGI-S agitation rating	Baseline and end-of-study or early termination, up to approximately 7 weeks per participant	Clinician-rated global agitation severity will be assessed using a study-specific modified Clinical Global Impression-Severity (CGI-S) agitation rating. The modified CGI-S agitation rating uses a 7-point scale, with higher scores indicating greater agitation severity. Scores will be summarized descriptively to explore change in global agitation severity from baseline to end-of-study or early termination.
Other	Descriptive patterns of medication use	Baseline through end-of-study or early termination, up to approximately 7 weeks per participant	Medication use will be summarized descriptively, including scheduled psychotropic medications, changes in scheduled psychotropic medications, PRN/as-needed medication use, PRN/rescue medication use for acute agitation or behavioural distress, and timing of PRN/rescue medication use relative to VR sessions. Medication data will not be used to direct clinical care and will not be interpreted as evidence of medication reduction efficacy.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this list from software.

Twenty rows a page, as JSON. No key.

GET https://conductscience.org/api/trials/v1/NCT07893678/registered

API reference For AI assistants