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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Experimental, LEAD IT! Programming | Experimental | 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. |
|
| No Intervention: Control, Standard Care / Programming | No Intervention | Participants in the Control arm will receive standard care / programming. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEAD IT! Programming | Behavioral | LEAD IT! is an intervention that enables persons with dementia to lead activities for their peers. The activities take place on tablets. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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.. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Month 1) and Post-Treatment (Month 4) |
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Inclusion Criteria for Persons with Dementia
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
Exclusion Criteria for Staff
-n/a
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| Name | Affiliation | Role |
|---|---|---|
| Michael Skrajner, MA | Hearthstone | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hearthstone Institute, LLC | Winchester | Massachusetts | 01890 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Persons With Dementia, Experimental (LEAD IT! Programming) | Participants in the Experimental / LEAD IT! arm will take part in LEAD IT! programming for 3 months. Participants were invited to participate in LEAD IT! programming twice per week. LEAD IT! Programming: LEAD IT! is an intervention that enables persons with dementia to lead activities for their peers. The activities take place on tablets. |
| FG001 | Persons With Dementia, Control (Standard Care / Activity Programming) | Participants in the Control arm will receive standard care / programming. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
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| Treatment |
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| Post Treatment |
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| ID | Title | Description |
|---|---|---|
| BG000 | Persons With Dementia, Experimental (LEAD IT! Programming) | Participants in the Experimental / LEAD IT! arm will take part in LEAD IT! programming for 3 months. Participants were invited to participate in LEAD IT! programming twice per week. LEAD IT! Programming: LEAD IT! is an intervention that enables persons with dementia to lead activities for their peers. The activities take place on tablets. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Month 1) and Treatment (Months 2, 3, and 4) |
|
5 months
The communities that participated in this study were asked to report any adverse events within 48 hours of their occurrence. However, there is always a chance that they could forget to tell us about an event. So, we also do the following: once per month, a researcher contacts the key contact and asks whether any adverse events occurred in the past month. If the key contact reports an adverse event, the researcher asks for details on the event, such as date/time of occurrence, severity, etc.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Persons With Dementia, Experimental (LEAD IT! Programming) | Participants in the Experimental / LEAD IT! arm will take part in LEAD IT! programming for 3 months. Participants were invited to participate in LEAD IT! programming twice per week. LEAD IT! Programming: LEAD IT! is an intervention that enables persons with dementia to lead activities for their peers. The activities take place on tablets. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Illness or Injury, Sent to hospital | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Skrajner | Hopeful Aging | 4404777881 | mike@hopefulaging.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 11, 2022 | May 22, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 3, 2023 | Oct 14, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015140 | Dementia, Vascular |
| D000544 | Alzheimer Disease |
| D000093902 | Mixed Dementias |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Two quasi-experiments will be conducted. Experiment #1 will test the Beta 1 Version of the app with 24 PWD and use a pre-post design. Experiment #1's goal is to examine and improve new activities and to make final changes to the overall app structure. Experiment #2, which will test Beta 2, will be a cluster randomized trial (CRT), consisting of pre- and post-intervention measurements of two nonequivalent groups: a Treatment Group (TG)-i.e. 48 PWD who receive the intervention - and a Control Group (CG)- i.e., 48 PWD receiving standard programming / care. Since Experiment #2 will occur after all tweaking is complete, it will represent the definitive trial of LEAD IT!'s proximal and distal effects.
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| 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. | 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. | Baseline (Month 1) and Treatment (Months 2, 3, and 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. |
| 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. | 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. | Baseline (Month 1) and Post-Treatment (Month 4) |
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| BG001 | Persons With Dementia, Control (Standard Care / Activity Programming) | Participants in the Control arm will receive standard care / programming. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
Participants in the Experimental / LEAD IT! arm will take part in LEAD IT! programming for 3 months. Participants were invited to participate in LEAD IT! programming twice per week. LEAD IT! Programming: LEAD IT! is an intervention that enables persons with dementia to lead activities for their peers. The activities take place on tablets.
| OG001 | Persons With Dementia, Control (Standard Care / Activity Programming) | Participants in the Control arm will receive standard care / programming. |
|
|
|
| Primary | 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.. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Month 1) and Treatment (Months 2, 3, and 4) |
|
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Month 1) and Treatment (Months 2, 3, and 4) |
|
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Month 1) and Treatment (Months 2, 3, and 4) |
|
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Month 1) and Treatment (Months 2, 3, and 4) |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on scale | Baseline (Month 1) and Post-Treatment (Month 4) |
|
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|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on scale | Baseline (Month 1) and Post-Treatment (Month 4) |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on scale | Baseline (Month 1) and Post-Treatment (Month 4) |
|
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on scale | Baseline (Month 1) and Post-Treatment (Month 4) |
|
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|
| 2 |
| 54 |
| 4 |
| 54 |
| 0 |
| 54 |
| EG001 | Persons With Dementia, Control (Standard Care / Activity Programming) | Participants in the Control arm will receive standard care / programming. | 4 | 41 | 7 | 41 | 0 | 41 |
| Death | Injury, poisoning and procedural complications | Systematic Assessment |
|
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| D002537 | Intracranial Arteriosclerosis |
| D020765 | Intracranial Arterial Diseases |
| D003704 | Dementia |
| D056784 | Leukoencephalopathies |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |