Trial Outcomes & Findings for LEAD IT! An App to Enable Persons With Early Stage Dementia to Lead Group Activities for Their Peers (NCT NCT05516342)

NCT ID: NCT05516342

Last Updated: 2024-12-02

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 182 participants
• Primary outcome timeframe: Baseline (Month 1) and Treatment (Months 2, 3, and 4)
• Results posted on: 2024-12-02

Participant Flow

Unit of analysis: Long-Term Care Communities

Participant milestones

Measure	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.	Persons With Dementia, Control (Standard Care / Activity Programming) Participants in the Control arm will receive standard care / programming.
Baseline STARTED	54 5	41 4
Baseline COMPLETED	54 5	41 4
Baseline NOT COMPLETED	0 0	0 0
Treatment STARTED	54 5	41 4
Treatment COMPLETED	51 5	37 4
Treatment NOT COMPLETED	3 0	4 0
Post Treatment STARTED	51 5	37 4
Post Treatment COMPLETED	47 5	35 4
Post Treatment NOT COMPLETED	4 0	2 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Persons With Dementia, Experimental (LEAD IT! Programming) n=54 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.	Persons With Dementia, Control (Standard Care / Activity Programming) n=41 Participants Participants in the Control arm will receive standard care / programming.	Total n=95 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	54 Participants n=5 Participants	41 Participants n=7 Participants	95 Participants n=5 Participants
Age, Continuous	87.13 years STANDARD_DEVIATION 7.39 • n=5 Participants	86.54 years STANDARD_DEVIATION 7.06 • n=7 Participants	86.87 years STANDARD_DEVIATION 7.21 • n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants	26 Participants n=7 Participants	73 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	15 Participants n=7 Participants	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	54 Participants n=5 Participants	41 Participants n=7 Participants	95 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	1 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	46 Participants n=5 Participants	40 Participants n=7 Participants	86 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	54 participants n=5 Participants	41 participants n=7 Participants	95 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Persons With Dementia, Experimental (LEAD IT! Programming) n=49 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.	Persons With Dementia, Control (Standard Care / Activity Programming) n=35 Participants Participants in the Control arm will receive standard care / 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 score on a scale Standard Deviation 0.53	-0.24 score on a scale Standard Deviation 0.50

PRIMARY outcome

Timeframe: 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..

Outcome measures

Measure	Persons With Dementia, Experimental (LEAD IT! Programming) n=49 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.	Persons With Dementia, Control (Standard Care / Activity Programming) n=35 Participants Participants in the Control arm will receive standard care / programming.
Change From Baseline to Treatment for Passive Engagement on the Menorah Park Engagement Scale	0.69 score on a scale Standard Deviation 0.65	-0.12 score on a scale Standard Deviation 0.55

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Persons With Dementia, Experimental (LEAD IT! Programming) n=49 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.	Persons With Dementia, Control (Standard Care / Activity Programming) n=35 Participants Participants in the Control arm will receive standard care / programming.
Change From Baseline to Treatment for Other Engagement on the Menorah Park Engagement Scale	-0.32 score on a scale Standard Deviation 0.48	0.28 score on a scale Standard Deviation 0.50

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Persons With Dementia, Experimental (LEAD IT! Programming) n=49 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.	Persons With Dementia, Control (Standard Care / Activity Programming) n=35 Participants Participants in the Control arm will receive standard care / programming.
Change From Baseline to Treatment for Non Engagement on the Menorah Park Engagement Scale	-.24 score on a scale Standard Deviation 0.35	0.02 score on a scale Standard Deviation 0.41

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Persons With Dementia, Experimental (LEAD IT! Programming) n=49 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.	Persons With Dementia, Control (Standard Care / Activity Programming) n=35 Participants Participants in the Control arm will receive standard care / programming.
Change From Baseline to Treatment for Pleasure on the Menorah Park Engagement Scale	0.32 score on a scale Standard Deviation 0.25	-0.02 score on a scale Standard Deviation 0.27

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Persons With Dementia, Experimental (LEAD IT! Programming) n=47 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.	Persons With Dementia, Control (Standard Care / Activity Programming) n=34 Participants Participants in the Control arm will receive standard care / programming.
Change From Baseline to Treatment on Dementia Related Quality of Life (DEMQOL)	1.51 score on scale Standard Deviation 11.75	1.08 score on scale Standard Deviation 15.39

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Persons With Dementia, Experimental (LEAD IT! Programming) n=47 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.	Persons With Dementia, Control (Standard Care / Activity Programming) n=35 Participants Participants in the Control arm will receive standard care / programming.
Change From Baseline to Treatment on the Neuropsychiatric Inventory-Nursing Home (NPI-NH), Frequency x Severity Score (FxS)	-0.15 score on scale Standard Deviation 15.32	3.06 score on scale Standard Deviation 9.04

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Persons With Dementia, Experimental (LEAD IT! Programming) n=46 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.	Persons With Dementia, Control (Standard Care / Activity Programming) n=34 Participants Participants in the Control arm will receive standard care / programming.
Change From Baseline to Treatment on the Geriatric Depression Scale-Short Form (GDS-SF)	-0.71 score on scale Standard Deviation 2.73	0.38 score on scale Standard Deviation 4.58

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Persons With Dementia, Experimental (LEAD IT! Programming) n=47 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.	Persons With Dementia, Control (Standard Care / Activity Programming) n=35 Participants Participants in the Control arm will receive standard care / programming.
Change From Baseline to Treatment on the Cohen Mansfield Agitation Inventory (CMAI)	-0.21 score on scale Standard Deviation 4.53	2.00 score on scale Standard Deviation 7.57

Adverse Events

Persons With Dementia, Experimental (LEAD IT! Programming)

Serious events: 4 serious events

Other events: 0 other events

Deaths: 2 deaths

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

Serious events: 7 serious events

Other events: 0 other events

Deaths: 4 deaths

Serious adverse events

Measure	Persons With Dementia, Experimental (LEAD IT! Programming) n=54 participants at risk 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.	Persons With Dementia, Control (Standard Care / Activity Programming) n=41 participants at risk Participants in the Control arm will receive standard care / programming.
Injury, poisoning and procedural complications Acute Illness or Injury, Sent to hospital	3.7% 2/54 • Number of events 2 • 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.	7.3% 3/41 • Number of events 3 • 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.
Injury, poisoning and procedural complications Death	3.7% 2/54 • Number of events 2 • 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.	9.8% 4/41 • Number of events 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.

Other adverse events

Adverse event data not reported

Additional Information

Michael Skrajner

Hopeful Aging

Phone: 4404777881

Email: mike@hopefulaging.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place