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Completed

NCT Number: NCT05516342

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

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!

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Key information

Conditions

Dementia, Vascular Alzheimer Disease Arterial Occlusive Diseases Arteriosclerosis Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Dementia Dementia, Mixed Intracranial Arterial Diseases Intracranial Arteriosclerosis Leukoencephalopathies Mental Disorders Mixed Dementias Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hearthstone Institute, LLC

Winchester, Massachusetts, 01890, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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)

    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.

  2. Change From Baseline to Treatment for Passive Engagement on the Menorah Park Engagement Scale

    Time frame: Baseline (Month 1) and Treatment (Months 2, 3, and 4)

    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..

  3. Change From Baseline to Treatment for Other Engagement on the Menorah Park Engagement Scale

    Time frame: Baseline (Month 1) and Treatment (Months 2, 3, and 4)

    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.

  4. Change From Baseline to Treatment for Non Engagement on the Menorah Park Engagement Scale

    Time frame: Baseline (Month 1) and Treatment (Months 2, 3, and 4)

    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.

  5. Change From Baseline to Treatment for Pleasure on the Menorah Park Engagement Scale

    Time frame: Baseline (Month 1) and Treatment (Months 2, 3, and 4)

    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.

Secondary outcomes

  1. Change From Baseline to Treatment on Dementia Related Quality of Life (DEMQOL)

    Time frame: Baseline (Month 1) and Post-Treatment (Month 4)

    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.

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

    Time frame: Baseline (Month 1) and Post-Treatment (Month 4)

    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.

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

    Time frame: Baseline (Month 1) and Post-Treatment (Month 4)

    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.

  4. Change From Baseline to Treatment on the Cohen Mansfield Agitation Inventory (CMAI)

    Time frame: Baseline (Month 1) and Post-Treatment (Month 4)

    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.

Sponsors and collaborators

Lead sponsor

Hopeful Aging

Industry

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 25, 2022
Registry last updated
Dec 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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