Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-25 @ 8:24 PM
Study NCT ID:
NCT05159869
Status:
COMPLETED
Last Update Posted:
2024-08-06
First Post:
2021-12-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
User-Led Meaningful Activity and Early-Stage Dementia
Sponsor:
Johns Hopkins University
Organization:
Study Overview
Official Title:
Meaningful Activity Intervention for Individuals With Early-Stage Dementia: Involving the End User in Intervention Design
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Neuropsychiatric symptoms are the most difficult, distressing, and burdensome aspects of dementia care and a catalyst for long-term care placement. Intervention studies have largely focused on helping caregivers manage these symptoms. However, little has been done with regard to persons at the earliest stages of dementia, nor have persons with dementia played a direct and active, central role in helping to design intervention studies. This study focuses on building, pilot testing, and evaluating a tailored activity plan developed with persons with early-stage dementia. The goal of the intervention is to provide persons at this early stage meaningful activities and a plan for adaptation with disease progression.
Detailed Description:
Dementia, a public health crisis, affects 47.5 million people worldwide and is projected to double in prevalence every 20 years. A degenerative disorder, dementia leads to a decreased ability to communicate and provide for oneself as the disease progresses, which often results in unmet needs. Unmet needs that are associated with dementia include boredom/sensory deprivation, loneliness, and the need for meaningful activity. The inability of persons with dementia to express or fulfill these needs has a range of adverse outcomes, including the manifestation of neuropsychiatric symptoms (NPS, e.g., agitation, aggression). As NPS are the most difficult, distressing, and burdensome aspects of dementia care and a catalyst for long-term care placement, intervention studies have largely focused on helping caregivers manage these symptoms. However, little has been done with regard to persons at the earliest stages of dementia, nor have persons with dementia played a direct and active, central role in helping to design intervention studies.
The lack of involvement of persons with dementia as study partners in the co-construction of interventions results in interventions that may not be relevant to or address the needs of the very population being targeted. Greater involvement of persons with dementia in intervention development is now recognized as a critical strategy for enhancing the relevance, acceptability and reach of interventions. Research suggests that some aspects of the premorbid sense of self are preserved even in advanced stages of dementia. Failure to recognize a person with dementia's continued awareness of sense of self can result in missed opportunities for involvement as a study partner as well as for developing effective therapeutic interventions. Thus, engaging persons with dementia in intervention development in the early stages of the disease can increase the likelihood that interventions are meaningful and linked to a sense of self throughout disease progression.
This study includes persons with early-stage dementia in the development of a meaningful activity plan. Prior activity intervention studies have primarily targeted participants at a moderate or later stage of dementia; consequently, persons with early dementia have largely been underrepresented in this line of research. As meaningful activity is considered central to the well-being of persons with dementia and is known to decrease negative emotions, it is anticipated that activity rooted in the interests and values of persons with early dementia will facilitate well-being as the disease progresses.
Objectives:
The study aims are as follows: 1) To identify delivery characteristics of an activity intervention for persons with dementia at the early stage, 2) To evaluate the feasibility, acceptability, and initial potential benefits of this protocol, and 3) To evaluate the feasibility of the revised protocol and examine its effects on outcomes. An exploratory aim evaluates whether activities are used independently of the intervention. The first aim will be accomplished through a series of focus groups with persons with dementia using best practices for inclusion, where participants will assist in identifying the key delivery characteristics participants would like to see in an intervention involving purposeful and meaningful activity. This aim will result in a proto-type intervention protocol, which will be evaluated through the second aim with approximately 10 persons with early stage dementia. Findings of this open-label trial will then be shared with key informants and an expert panel, and the protocol revised as needed based on feedback. The revised, testable protocol will be submitted to further testing via a pilot, two-group randomized trial with 60 community-dwelling persons with early-stage dementia (aim 3). Outcomes examined will include well-being, sense of control, frequency and severity of NPS, sense of self, and cognition.
The lack of involvement of persons with dementia as study partners in the co-construction of interventions results in interventions that may not be relevant to or address the needs of the very population being targeted. Greater involvement of persons with dementia in intervention development is now recognized as a critical strategy for enhancing the relevance, acceptability and reach of interventions. Research suggests that some aspects of the premorbid sense of self are preserved even in advanced stages of dementia. Failure to recognize a person with dementia's continued awareness of sense of self can result in missed opportunities for involvement as a study partner as well as for developing effective therapeutic interventions. Thus, engaging persons with dementia in intervention development in the early stages of the disease can increase the likelihood that interventions are meaningful and linked to a sense of self throughout disease progression.
This study includes persons with early-stage dementia in the development of a meaningful activity plan. Prior activity intervention studies have primarily targeted participants at a moderate or later stage of dementia; consequently, persons with early dementia have largely been underrepresented in this line of research. As meaningful activity is considered central to the well-being of persons with dementia and is known to decrease negative emotions, it is anticipated that activity rooted in the interests and values of persons with early dementia will facilitate well-being as the disease progresses.
Objectives:
The study aims are as follows: 1) To identify delivery characteristics of an activity intervention for persons with dementia at the early stage, 2) To evaluate the feasibility, acceptability, and initial potential benefits of this protocol, and 3) To evaluate the feasibility of the revised protocol and examine its effects on outcomes. An exploratory aim evaluates whether activities are used independently of the intervention. The first aim will be accomplished through a series of focus groups with persons with dementia using best practices for inclusion, where participants will assist in identifying the key delivery characteristics participants would like to see in an intervention involving purposeful and meaningful activity. This aim will result in a proto-type intervention protocol, which will be evaluated through the second aim with approximately 10 persons with early stage dementia. Findings of this open-label trial will then be shared with key informants and an expert panel, and the protocol revised as needed based on feedback. The revised, testable protocol will be submitted to further testing via a pilot, two-group randomized trial with 60 community-dwelling persons with early-stage dementia (aim 3). Outcomes examined will include well-being, sense of control, frequency and severity of NPS, sense of self, and cognition.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1K23AG05880901 | OTHER | National Institute on Aging | View |