CompletedNCT05516342Updated Dec 2, 2024Results posted

LEAD IT! An App to Enable Persons With Early Stage Dementia to Lead Group Activities for Their Peers

An interventional study of LEAD IT! Programming in Dementia, Vascular, Alzheimer Disease and Dementia, Mixed, sponsored by Hopeful Aging. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-02.

Sponsored by Hopeful Aging · Not applicable, Interventional, and Treatment

From the registry’s dates

Registered 1 year 9 months after the study started (first participant enrolled Nov 2020, registered Aug 2022).

Phase: Not applicable
Study type: Interventional
Enrollment: 182
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The proposed Phase 2 project will involve the further development and evaluation of LEAD IT!, which is a tablet-based app designed to enable persons with dementia to lead activities for their peers (i.e., other persons with dementia). The study will examine the clinical outcomes of long-term use of the app by both Resident Leaders (RLs) and Resident Players (RPs).

The Specific Aims of the proposed Phase 2 project are to:

Develop improved Beta 1 and Beta 2 Versions of LEAD IT! with sufficient content to facilitate six activities twice per week for 4.5 months.
Examine the extent to which RLs are able to serve as leaders while using LEAD IT!
Examine the effects of resident-led LEAD IT! programming on RPs.
Examine PWD and staff satisfaction with LEAD IT!

Read the detailed description

he proposed Phase 2 project will involve the further development and evaluation of LEAD IT!, as well as examine the clinical outcomes of long-term use of the app by both RLs and RPs.

The Specific Aims of the proposed Phase 2 project are to:

Develop improved Beta 1 and Beta 2 Versions of LEAD IT! with sufficient content to facilitate six activities twice per week for 4.5 months. During Months 1-7, the Beta 1 version of the app will be created by the study's Development Team (DT). During Months 13-15, the DT will create an improved Beta 2 version, based on lessons learned in Beta 1 testing.
Examine the extent to which RLs are able to serve as leaders while using LEAD IT! During all intervention sessions, researchers will track the extent to which each RL follows key steps involved in leading each activity. RLs will be considered successful if they follow the steps 80% of the time and require less staff assistance on less than 20% of steps.
Examine the effects of resident-led LEAD IT! programming on RPs. Two quasi-experiments will be conducted. Experiment #1, which will test the Beta 1 version of LEAD IT!, will use a pre-post design. Proximal (immediate) effects will be assessed by examining RP's levels of engagement/affect during baseline (standard) activities and again during LEAD IT! activities. It is hypothesized that LEAD IT! will result in higher quality engagement than baseline activities. Experiment #2, which will test the Beta 2 version of the app, will be a cluster randomized trial (CRT), consisting of pre- and post-intervention measurements of a Treatment Group (TG)-which will consist of PWD who receive the intervention - and a Control Group (CG) - which will consist of PWD who receive standard programming / care. Since Experiment #2 will occur after all improvements to the app have been made, it will represent the definitive trial of the LEAD IT! app's impact on PWD. For proximal (immediate) measures, it is anticipated that there will be a Group x Time interaction effect, with TG participants exhibiting significantly greater increases in positive forms of engagement, as compared to CG participants. For distal measures, it is anticipated that there will be a Group x Time interaction effect, with TG participants exhibiting significantly greater increases in quality of life (based upon the DEMQOL) at treatment, as compared to CG participants.
Examine PWD and staff satisfaction with LEAD IT! This will be achieved by eliciting feedback from PWD and staff members. PWD and staff members will be considered "highly satisfied" with the app if 85% are satisfied with the app.

Conditions studied

Dementia, Vascular
Alzheimer Disease
Dementia, Mixed

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Keywords

psychosocial
social
non-pharmacological intervention

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's enrollment of 182 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Hopeful Aging is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Inclusion Criteria for Persons with Dementia

Must reside in an Assisted Living Facility or NH
Must be at least 65 years old
Must speak and read English
Must have a clinical diagnosis of dementia (any type).
Resident-players must score at least five on the Mini-Mental State Examination (MMSE)
Resident-leaders must score at least 13 on the MMSE
Resident-leaders must possess at least 70% of the characteristics of successful leaders, based upon the I'm Still Here Skills Inventory, Short Edition, Modified

Exclusion Criteria for Persons with Dementia -the person shows signs of rapid cognitive decline or physical deterioration over the last six months, as evidenced by medical records.

Inclusion Criteria for Staff

Must be at least 18 years old
Must speak English

Exclusion Criteria for Staff

-n/a

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 182 participants (actual)

Study arms

Experimental
Experimental: Experimental, LEAD IT! Programming
Participants in the Experimental / LEAD IT! arm will take part in LEAD IT! programming for 18 weeks. The programming will occur twice per week, for a total of 36 sessions.
Behavioral: LEAD IT! Programming
No intervention
No Intervention: Control, Standard Care / Programming
Participants in the Control arm will receive standard care / programming.

Interventions

BehavioralLEAD IT! Programming
LEAD IT! is an intervention that enables persons with dementia to lead activities for their peers. The activities take place on tablets.

What researchers measure

Primary outcomes

Change From Baseline to Treatment for Constructive Engagement on the Menorah Park Engagement Scale [Time Frame: Baseline (Month 1) and Treatment (Months 2, 3, and 4)
Constructive Engagement on the Menorah Park Engagement Scale is defined as doing or commenting on something related to the target activity. During baseline, multiple observations of "standard" activities were observed and a single mean score was calculated for all sessions observed during that month. Then, again, during treatment, multiple treatment activity sessions were observed over the course of three months (Months 2, 3, and 4) and a single mean score was calculated. The minimum value for Constructive Engagement is zero (0) and the maximum score is two (2). Higher scores represent a better outcome.
Time frame: Baseline (Month 1) and Treatment (Months 2, 3, and 4)
Change From Baseline to Treatment for Passive Engagement on the Menorah Park Engagement Scale
Passive Engagement on the Menorah Park Engagement Scale is defined as listening or watching something related to the target activity.During baseline, multiple observations of "standard" activities were observed and a single mean score was calculated for all sessions observed during that month. Then, again, during treatment, multiple treatment activity sessions were observed over the course of three months (Months 2, 3, and 4) and a single mean score was calculated. The minimum value for Passive Engagement is zero (0) and the maximum score is two (2). Higher scores represent a better outcome..
Time frame: Baseline (Month 1) and Treatment (Months 2, 3, and 4)
Change From Baseline to Treatment for Other Engagement on the Menorah Park Engagement Scale
Other Engagement on the Menorah Park Engagement Scale is defined as doing, commenting, listening, or watching something NOT related to the target activity. During baseline, multiple observations of "standard" activities were observed and a single mean score was calculated for all sessions observed during that month. Then, again, during treatment, multiple treatment activity sessions were observed over the course of three months (Months 2, 3, and 4) and a single mean score was calculated. The minimum value for Other Engagement is zero (0) and the maximum score is two (2). Lower scores represent a better outcome.
Time frame: Baseline (Month 1) and Treatment (Months 2, 3, and 4)
Change From Baseline to Treatment for Non Engagement on the Menorah Park Engagement Scale
Non-Engagement on the Menorah Park Engagement Scale is defined as sleeping and/or staring into space. During baseline, multiple observations of "standard" activities were observed and a single mean score was calculated for all sessions observed during that month. Then, again, during treatment, multiple treatment activity sessions were observed over the course of three months (Months 2, 3, and 4) and a single mean score was calculated. The minimum value for Non-Engagement is zero (0) and the maximum score is two (2). Lower scores represent a better outcome.
Time frame: Baseline (Month 1) and Treatment (Months 2, 3, and 4)
Change From Baseline to Treatment for Pleasure on the Menorah Park Engagement Scale
Pleasure on the Menorah Park Engagement Scale is defined as clearly observable laughing or smiling. During baseline, multiple observations of "standard" activities were observed and a single mean score was calculated for all sessions observed during that month. Then, again, during treatment, multiple treatment activity sessions were observed over the course of three months (Months 2, 3, and 4) and a single mean score was calculated. The minimum value for Pleasure is zero (0) and the maximum score is two (2). Lower scores represent a better outcome.
Time frame: Baseline (Month 1) and Treatment (Months 2, 3, and 4)

Secondary outcomes

Change From Baseline to Treatment on Dementia Related Quality of Life (DEMQOL)
The Dementia Related Quality of Life Scale is a 28 item scale that examines quality of life in persons with dementia. The score ranges for 28 to 112. Higher scores represent a better outcome.
Time frame: Baseline (Month 1) and Post-Treatment (Month 4)
Change From Baseline to Treatment on the Neuropsychiatric Inventory-Nursing Home (NPI-NH), Frequency x Severity Score (FxS)
The NPI-NH examines 10 types of neuropsychiatric symptoms in persons with dementia, with the FxS score looking creating a composite score that takes into account frequency and severity of the symptoms. The score ranges from 0 to 120. Lower scores represent a better outcome.
Time frame: Baseline (Month 1) and Post-Treatment (Month 4)
Change From Baseline to Treatment on the Geriatric Depression Scale-Short Form (GDS-SF)
The GDS-SF consists of 15 questions requiring "yes" or "no" answers. It is specifically developed for use with older adults. For persons unable to answer the questions, a proxy can be used. The total score ranges from 0 to 15, with lower scores indicating a better outcome.
Time frame: Baseline (Month 1) and Post-Treatment (Month 4)
Change From Baseline to Treatment on the Cohen Mansfield Agitation Inventory (CMAI)
The 14-item CMAI is a caregiver rated questionnaire using a 5-point Likert scale to rate the frequency of disturbing behaviors in dementia such as verbal/physical aggression, general restlessness, strange noises, and so on. Scores range from 14 to 70, with lower scores indicating a better outcome.
Time frame: Baseline (Month 1) and Post-Treatment (Month 4)

Results

Posted Dec 2, 2024

Participant flow

Baseline

Participant flow — Baseline
Milestone	Persons With Dementia, Experimental (LEAD IT! Programming)	Persons With Dementia, Control (Standard Care / Activity Programming)
Started	54	41
Completed	54	41
Not completed	0	0

Treatment

Participant flow — Treatment
Milestone	Persons With Dementia, Experimental (LEAD IT! Programming)	Persons With Dementia, Control (Standard Care / Activity Programming)
Started	54	41
Completed	51	37
Not completed	3	4

Post Treatment

Participant flow — Post Treatment
Milestone	Persons With Dementia, Experimental (LEAD IT! Programming)	Persons With Dementia, Control (Standard Care / Activity Programming)
Started	51	37
Completed	47	35
Not completed	4	2

Outcome measures

PrimaryChange From Baseline to Treatment for Constructive Engagement on the Menorah Park Engagement Scale [Time Frame: Baseline (Month 1) and Treatment (Months 2, 3, and 4)

Constructive Engagement on the Menorah Park Engagement Scale is defined as doing or commenting on something related to the target activity. During baseline, multiple observations of "standard" activities were observed and a single mean score was calculated for all sessions observed during that month. Then, again, during treatment, multiple treatment activity sessions were observed over the course of three months (Months 2, 3, and 4) and a single mean score was calculated. The minimum value for Constructive Engagement is zero (0) and the maximum score is two (2). Higher scores represent a better outcome.

Time frame:: Baseline (Month 1) and Treatment (Months 2, 3, and 4)
Reported as:: Mean · score on a scale

Change From Baseline to Treatment for Constructive Engagement on the Menorah Park Engagement Scale [Time Frame: Baseline (Month 1) and Treatment (Months 2, 3, and 4)
score on a scale	Persons With Dementia, Experimental (LEAD IT! Programming)	Persons With Dementia, Control (Standard Care / Activity Programming)
Change From Baseline to Treatment for Constructive Engagement on the Menorah Park Engagement Scale [Time Frame: Baseline (Month 1) and Treatment (Months 2, 3, and 4)	0.19 ± 0.53	-0.24 ± 0.50

Statistical analysis

Persons With Dementia, Experimental (LEAD IT! Programming) vs Persons With Dementia, Control (Standard Care / Activity Programming) · ANOVA · p = <0.01

PrimaryChange From Baseline to Treatment for Passive Engagement on the Menorah Park Engagement Scale

Passive Engagement on the Menorah Park Engagement Scale is defined as listening or watching something related to the target activity.During baseline, multiple observations of "standard" activities were observed and a single mean score was calculated for all sessions observed during that month. Then, again, during treatment, multiple treatment activity sessions were observed over the course of three months (Months 2, 3, and 4) and a single mean score was calculated. The minimum value for Passive Engagement is zero (0) and the maximum score is two (2). Higher scores represent a better outcome..

Time frame:: Baseline (Month 1) and Treatment (Months 2, 3, and 4)
Reported as:: Mean · score on a scale

Change From Baseline to Treatment for Passive Engagement on the Menorah Park Engagement Scale
score on a scale	Persons With Dementia, Experimental (LEAD IT! Programming)	Persons With Dementia, Control (Standard Care / Activity Programming)
Change From Baseline to Treatment for Passive Engagement on the Menorah Park Engagement Scale	0.69 ± 0.65	-0.12 ± 0.55

Statistical analysis

Persons With Dementia, Experimental (LEAD IT! Programming) vs Persons With Dementia, Control (Standard Care / Activity Programming) · ANOVA · p = <0.01

PrimaryChange From Baseline to Treatment for Other Engagement on the Menorah Park Engagement Scale

Other Engagement on the Menorah Park Engagement Scale is defined as doing, commenting, listening, or watching something NOT related to the target activity. During baseline, multiple observations of "standard" activities were observed and a single mean score was calculated for all sessions observed during that month. Then, again, during treatment, multiple treatment activity sessions were observed over the course of three months (Months 2, 3, and 4) and a single mean score was calculated. The minimum value for Other Engagement is zero (0) and the maximum score is two (2). Lower scores represent a better outcome.

Time frame:: Baseline (Month 1) and Treatment (Months 2, 3, and 4)
Reported as:: Mean · score on a scale

Change From Baseline to Treatment for Other Engagement on the Menorah Park Engagement Scale
score on a scale	Persons With Dementia, Experimental (LEAD IT! Programming)	Persons With Dementia, Control (Standard Care / Activity Programming)
Change From Baseline to Treatment for Other Engagement on the Menorah Park Engagement Scale	-0.32 ± 0.48	0.28 ± 0.50

Statistical analysis

Persons With Dementia, Experimental (LEAD IT! Programming) vs Persons With Dementia, Control (Standard Care / Activity Programming) · ANOVA · p = <0.01

PrimaryChange From Baseline to Treatment for Non Engagement on the Menorah Park Engagement Scale

Non-Engagement on the Menorah Park Engagement Scale is defined as sleeping and/or staring into space. During baseline, multiple observations of "standard" activities were observed and a single mean score was calculated for all sessions observed during that month. Then, again, during treatment, multiple treatment activity sessions were observed over the course of three months (Months 2, 3, and 4) and a single mean score was calculated. The minimum value for Non-Engagement is zero (0) and the maximum score is two (2). Lower scores represent a better outcome.

Time frame:: Baseline (Month 1) and Treatment (Months 2, 3, and 4)
Reported as:: Mean · score on a scale

Change From Baseline to Treatment for Non Engagement on the Menorah Park Engagement Scale
score on a scale	Persons With Dementia, Experimental (LEAD IT! Programming)	Persons With Dementia, Control (Standard Care / Activity Programming)
Change From Baseline to Treatment for Non Engagement on the Menorah Park Engagement Scale	-.24 ± 0.35	0.02 ± 0.41

Statistical analysis

Persons With Dementia, Experimental (LEAD IT! Programming) vs Persons With Dementia, Control (Standard Care / Activity Programming) · ANOVA · p = <0.01

PrimaryChange From Baseline to Treatment for Pleasure on the Menorah Park Engagement Scale

Pleasure on the Menorah Park Engagement Scale is defined as clearly observable laughing or smiling. During baseline, multiple observations of "standard" activities were observed and a single mean score was calculated for all sessions observed during that month. Then, again, during treatment, multiple treatment activity sessions were observed over the course of three months (Months 2, 3, and 4) and a single mean score was calculated. The minimum value for Pleasure is zero (0) and the maximum score is two (2). Lower scores represent a better outcome.

Time frame:: Baseline (Month 1) and Treatment (Months 2, 3, and 4)
Reported as:: Mean · score on a scale

Change From Baseline to Treatment for Pleasure on the Menorah Park Engagement Scale
score on a scale	Persons With Dementia, Experimental (LEAD IT! Programming)	Persons With Dementia, Control (Standard Care / Activity Programming)
Change From Baseline to Treatment for Pleasure on the Menorah Park Engagement Scale	0.32 ± 0.25	-0.02 ± 0.27

Statistical analysis

Persons With Dementia, Experimental (LEAD IT! Programming) vs Persons With Dementia, Control (Standard Care / Activity Programming) · ANOVA · p = <0.01

SecondaryChange From Baseline to Treatment on Dementia Related Quality of Life (DEMQOL)

The Dementia Related Quality of Life Scale is a 28 item scale that examines quality of life in persons with dementia. The score ranges for 28 to 112. Higher scores represent a better outcome.

Time frame:: Baseline (Month 1) and Post-Treatment (Month 4)
Reported as:: Mean · score on scale

Change From Baseline to Treatment on Dementia Related Quality of Life (DEMQOL)
score on scale	Persons With Dementia, Experimental (LEAD IT! Programming)	Persons With Dementia, Control (Standard Care / Activity Programming)
Change From Baseline to Treatment on Dementia Related Quality of Life (DEMQOL)	1.51 ± 11.75	1.08 ± 15.39

Statistical analysis

Persons With Dementia, Experimental (LEAD IT! Programming) vs Persons With Dementia, Control (Standard Care / Activity Programming) · ANOVA · p = 0.89

SecondaryChange From Baseline to Treatment on the Neuropsychiatric Inventory-Nursing Home (NPI-NH), Frequency x Severity Score (FxS)

The NPI-NH examines 10 types of neuropsychiatric symptoms in persons with dementia, with the FxS score looking creating a composite score that takes into account frequency and severity of the symptoms. The score ranges from 0 to 120. Lower scores represent a better outcome.

Time frame:: Baseline (Month 1) and Post-Treatment (Month 4)
Reported as:: Mean · score on scale

Change From Baseline to Treatment on the Neuropsychiatric Inventory-Nursing Home (NPI-NH), Frequency x Severity Score (FxS)
score on scale	Persons With Dementia, Experimental (LEAD IT! Programming)	Persons With Dementia, Control (Standard Care / Activity Programming)
Change From Baseline to Treatment on the Neuropsychiatric Inventory-Nursing Home (NPI-NH), Frequency x Severity Score (FxS)	-0.15 ± 15.32	3.06 ± 9.04

Statistical analysis

Persons With Dementia, Experimental (LEAD IT! Programming) vs Persons With Dementia, Control (Standard Care / Activity Programming) · ANOVA · p = 0.27

SecondaryChange From Baseline to Treatment on the Geriatric Depression Scale-Short Form (GDS-SF)

The GDS-SF consists of 15 questions requiring "yes" or "no" answers. It is specifically developed for use with older adults. For persons unable to answer the questions, a proxy can be used. The total score ranges from 0 to 15, with lower scores indicating a better outcome.

Time frame:: Baseline (Month 1) and Post-Treatment (Month 4)
Reported as:: Mean · score on scale

Change From Baseline to Treatment on the Geriatric Depression Scale-Short Form (GDS-SF)
score on scale	Persons With Dementia, Experimental (LEAD IT! Programming)	Persons With Dementia, Control (Standard Care / Activity Programming)
Change From Baseline to Treatment on the Geriatric Depression Scale-Short Form (GDS-SF)	-0.71 ± 2.73	0.38 ± 4.58

Statistical analysis

Persons With Dementia, Experimental (LEAD IT! Programming) vs Persons With Dementia, Control (Standard Care / Activity Programming) · ANOVA · p = 0.19

SecondaryChange From Baseline to Treatment on the Cohen Mansfield Agitation Inventory (CMAI)

The 14-item CMAI is a caregiver rated questionnaire using a 5-point Likert scale to rate the frequency of disturbing behaviors in dementia such as verbal/physical aggression, general restlessness, strange noises, and so on. Scores range from 14 to 70, with lower scores indicating a better outcome.

Time frame:: Baseline (Month 1) and Post-Treatment (Month 4)
Reported as:: Mean · score on scale

Change From Baseline to Treatment on the Cohen Mansfield Agitation Inventory (CMAI)
score on scale	Persons With Dementia, Experimental (LEAD IT! Programming)	Persons With Dementia, Control (Standard Care / Activity Programming)
Change From Baseline to Treatment on the Cohen Mansfield Agitation Inventory (CMAI)	-0.21 ± 4.53	2.00 ± 7.57

Statistical analysis

Persons With Dementia, Experimental (LEAD IT! Programming) vs Persons With Dementia, Control (Standard Care / Activity Programming) · ANOVA · p = 0.10

Adverse events

Collected over 5 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Persons With Dementia, Experimental (LEAD IT! Programming)	2/54 (3.7%)	4/54 (7.4%)	0/54 (0%)
Persons With Dementia, Control (Standard Care / Activity Programming)	4/41 (9.8%)	7/41 (17.1%)	0/41 (0%)

Most frequent serious events

Most frequent serious events
Event	Persons With Dementia, Experimental (LEAD IT! Programming)	Persons With Dementia, Control (Standard Care / Activity Programming)
DeathInjury, poisoning and procedural complications	2/54	4/41
Acute Illness or Injury, Sent to hospitalInjury, poisoning and procedural complications	2/54	3/41

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Persons With Dementia, Experimental (LEAD IT! Programming)	Persons With Dementia, Control (Standard Care / Activity Programming)	Total
<=18 years	0	0	0
Between 18 and 65 years	0	0	0
>=65 years	54	41	95

Age, Continuous
Age, Continuous(years)	Persons With Dementia, Experimental (LEAD IT! Programming)	Persons With Dementia, Control (Standard Care / Activity Programming)	Total
Mean	87.13 ± 7.39	86.54 ± 7.06	86.87 ± 7.21

Sex: Female, Male
Sex: Female, Male(Participants)	Persons With Dementia, Experimental (LEAD IT! Programming)	Persons With Dementia, Control (Standard Care / Activity Programming)	Total
Female	47	26	73
Male	7	15	22

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Persons With Dementia, Experimental (LEAD IT! Programming)	Persons With Dementia, Control (Standard Care / Activity Programming)	Total
Hispanic or Latino	0	0	0
Not Hispanic or Latino	54	41	95
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Persons With Dementia, Experimental (LEAD IT! Programming)	Persons With Dementia, Control (Standard Care / Activity Programming)	Total
American Indian or Alaska Native	0	0	0
Asian	1	0	1
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	7	1	8
White	46	40	86
More than one race	0	0	0
Unknown or Not Reported	0	0	0

Region of Enrollment
Region of Enrollment(participants)	Persons With Dementia, Experimental (LEAD IT! Programming)	Persons With Dementia, Control (Standard Care / Activity Programming)	Total
United States	54	41	95

Study locations

1 site

The Hearthstone Institute, LLC
Winchester, Massachusetts 01890, United States

References and documents

Study documents

Study protocol · Feb 11, 2022
Statistical analysis plan · Aug 3, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05516342
Lead sponsor: Hopeful Aging
Responsible party: Sponsor
First posted: Aug 25, 2022
Start date: Nov 10, 2020
Primary completion: Jun 11, 2023
Completion: Jun 11, 2023
Results posted: Dec 2, 2024
Last update: Dec 2, 2024

Study contacts

Michael Skrajner, MA

principal investigator · Hearthstone

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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