NCT05516342

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

Completed NA Results posted Last updated 2 December 2024

What this trial tests

NA trial testing LEAD IT! Programming in Dementia, Vascular in 182 participants. Completed in 11 June 2023.

Timeline

10 November 2020

Primary endpoint
11 June 2023

11 June 2023

Quick facts

Lead sponsor	Hopeful Aging
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	182
Start date	10 November 2020
Primary completion	11 June 2023
Estimated completion	11 June 2023
Sites	1 location across United States

Drugs / interventions tested

• LEAD IT! Programming

Conditions studied

• Dementia, Vascular — all drugs for Dementia, Vascular →
• Alzheimer Disease — all drugs for Alzheimer Disease →
• Dementia, Mixed — all drugs for Dementia, Mixed →

Sponsor

Hopeful Aging

Who can join

18 and older, any sex, with Dementia, Vascular or Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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) Primary · 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 bette

Group	Value	95% CI
Persons With Dementia, Experimental (LEAD IT! Programming)	0.19	± 0.53
Persons With Dementia, Control (Standard Care / Activity Programming)	-0.24	± 0.50

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

Group	Value	95% CI
Persons With Dementia, Experimental (LEAD IT! Programming)	0.69	± 0.65
Persons With Dementia, Control (Standard Care / Activity Programming)	-0.12	± 0.55

Change From Baseline to Treatment for Other Engagement on the Menorah Park Engagement Scale Primary · 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

Group	Value	95% CI
Persons With Dementia, Experimental (LEAD IT! Programming)	-0.32	± 0.48
Persons With Dementia, Control (Standard Care / Activity Programming)	0.28	± 0.50

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

Group	Value	95% CI
Persons With Dementia, Experimental (LEAD IT! Programming)	-.24	± 0.35
Persons With Dementia, Control (Standard Care / Activity Programming)	0.02	± 0.41

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

Group	Value	95% CI
Persons With Dementia, Experimental (LEAD IT! Programming)	0.32	± 0.25
Persons With Dementia, Control (Standard Care / Activity Programming)	-0.02	± 0.27

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

Group	Value	95% CI
Persons With Dementia, Experimental (LEAD IT! Programming)	1.51	± 11.75
Persons With Dementia, Control (Standard Care / Activity Programming)	1.08	± 15.39

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

Group	Value	95% CI
Persons With Dementia, Experimental (LEAD IT! Programming)	-0.15	± 15.32
Persons With Dementia, Control (Standard Care / Activity Programming)	3.06	± 9.04

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

Group	Value	95% CI
Persons With Dementia, Experimental (LEAD IT! Programming)	-0.71	± 2.73
Persons With Dementia, Control (Standard Care / Activity Programming)	0.38	± 4.58

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

Group	Value	95% CI
Persons With Dementia, Experimental (LEAD IT! Programming)	-0.21	± 4.53
Persons With Dementia, Control (Standard Care / Activity Programming)	2.00	± 7.57

Adverse events — posted to ClinicalTrials.gov

Time frame: 5 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Persons With Dementia, Experimental (LEAD IT! Programming)

Serious: 4/54 (7%)

Deaths: 2/54

Persons With Dementia, Control (Standard Care / Activity Programming)

Serious: 7/41 (17%)

Deaths: 4/41

Serious adverse events (2 terms)

Reaction	System	Persons With Dementia, Exp…	Persons With Dementia, Con…
Death	Injury, poisoning and procedural complications	—	—
Acute Illness or Injury, Sent to hospital	Injury, poisoning and procedural complications	—	—

Most-reported serious reactions: Death, Acute Illness or Injury, Sent to hospital.

Data from ClinicalTrials.gov NCT05516342 adverse events section.

Sponsor's own description

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!

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.