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

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ClinicalTrials.gov Identifier: NCT04899973
Recruitment Status : Recruiting
First Posted : May 25, 2021
Last Update Posted : May 25, 2021
Sponsor:
Information provided by (Responsible Party):
Michael Skrajner, Hearthstone Alzheimer Care

Brief 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:

  1. 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.
  2. Examine the extent to which RLs are able to serve as leaders while using LEAD IT!
  3. Examine the effects of resident-led LEAD IT! programming on RPs.
  4. Examine PWD and staff satisfaction with LEAD IT!

Condition or disease Intervention/treatment Phase
Dementia Alzheimer Disease Behavioral: LEAD IT! programming Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: LEAD IT! An App to Enable Persons With Early Stage Dementia to Lead Group Activities for Their Peers
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arm Intervention/treatment
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
LEAD IT! is an intervention that enables persons with dementia to lead activities for their peers. The activities take place on tablets.

No Intervention: Control, Standard Care / Programming
Participants in the Control arm will receive standard care / programming.



Primary Outcome Measures :
  1. Menorah Park Engagement Scale [ Time Frame: Baseline--that is, week 1 thru week 4 ]
    The Menorah Park Engagement Scale measures four types of engagement. Constructive Engagement, Passive Engagement, Other Engagement, and Non-Engagement. It also measures pleasure.

  2. Menorah Park Engagement Scale [ Time Frame: Treatment--that is, during week 5 thru week 22 ]
    The Menorah Park Engagement Scale measures four types of engagement. Constructive Engagement, Passive Engagement, Other Engagement, and Non-Engagement. It also measures pleasure.

  3. Dementia Related Quality of Life [ Time Frame: Baseline--that is, week 1 thru 4 ]
    The Dementia Related Quality of Life measures quality of life in persons with dementia. There is a direct interview and proxy version. The DEMQOL is a 28-item self-reported measure related to health-related quality-of-life (HRQL) in patients with dementia. The DEMQOL takes cognition, negative emotion, positive emotion, social relationships, and loneliness into consideration. The DEMQOL-Proxy is a 31-item test completed by the caretaker and focuses on cognition, negative emotion, positive emotion, daily activities, and appearance. The DEMQOL can be completed by patients with mild to moderate dementia. Whereas the DEMQOL-Proxy is completed by a caregiver for individuals with mild, moderate, or severe dementia. In one study, an early version of the DEMQOL was used and included other inclusion criteria such as ability to communicate and understand others, no major illnesses or disabilities, and able to communicate in English.

  4. Dementia Related Quality of Life (DEMQOL) [ Time Frame: Post-Treatment--that is during week 23 thru week 24. ]
    The Dementia Related Quality of Life measures quality of life in persons with dementia. There is a direct interview and proxy version. The DEMQOL is a 28-item self-reported measure related to health-related quality-of-life (HRQL) in patients with dementia. The DEMQOL takes cognition, negative emotion, positive emotion, social relationships, and loneliness into consideration. The DEMQOL-Proxy is a 31-item test completed by the caretaker and focuses on cognition, negative emotion, positive emotion, daily activities, and appearance. The DEMQOL can be completed by patients with mild to moderate dementia. Whereas the DEMQOL-Proxy is completed by a caregiver for individuals with mild, moderate, or severe dementia. In one study, an early version of the DEMQOL was used and included other inclusion criteria such as ability to communicate and understand others, no major illnesses or disabilities, and able to communicate in English.


Secondary Outcome Measures :
  1. Geriatric Depression Scale-Short Form [ Time Frame: Baseline--that is, week 1 thru week 4 ]
    This is a 15-item measure of depression in older adults that is conducted via direct interview.

  2. Geriatric Depression Scale-Short Form [ Time Frame: Post-Treatment--that is during week 23 thru week 24. ]
    This is a 15-item measure of depression in older adults that is conducted via direct interview.

  3. Cohen Mansfield Agitation Inventory [ Time Frame: Baseline--that is, week 1 thru week 4 ]
    The Cohen-Mansfield Agitation Inventory is a scale intended to systematically assess agitation in older adults.

  4. Cohen Mansfield Agitation Inventory [ Time Frame: Post-Treatment--that is during week 23 thru week 24. ]
    The Cohen-Mansfield Agitation Inventory is a scale intended to systematically assess agitation in older adults.

  5. Neuropsychiatric Inventory-Nursing Home [ Time Frame: Baseline--that is, week 1 thru week 4 ]
    The Neuropsychiatric Inventory-Nursing Home is a comprehensive assessment of psychopathology in persons with dementia, focused on people residing in nursing homes.

  6. Neuropsychiatric Inventory-Nursing Home [ Time Frame: Post-Treatment--that is during week 23 thru week 24. ]
    The Neuropsychiatric Inventory-Nursing Home is a comprehensive assessment of psychopathology in persons with dementia, focused on people residing in nursing homes.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04899973


Contacts
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Contact: Michael Skrajner, MA 4404777881 skrajner@thehearth.org
Contact: Gregg Gorzelle 4406657812 gorzelle@thehearth.org

Locations
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United States, Massachusetts
Hearthstone Alzheimer Care Recruiting
Winchester, Massachusetts, United States, 01890
Contact: Michael Skrajner, MA    440-477-7881    skrajner@thehearth.org   
Sponsors and Collaborators
Hearthstone Alzheimer Care
Publications:
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Responsible Party: Michael Skrajner, Director of Research and Innovation, Hearthstone Alzheimer Care
ClinicalTrials.gov Identifier: NCT04899973    
Other Study ID Numbers: AG059443
First Posted: May 25, 2021    Key Record Dates
Last Update Posted: May 25, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders