Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06444841
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-05-21
Brief Title:
Paper-Based and Smartphone-Based Memory Supports
Sponsor:
Baylor University
Organization:
Baylor University
Study Overview
Official Title:
Smartphone-Based Solutions for Prospective Memory in Mild Cognitive Impairment and Dementia
Status:
RECRUITING
Status Verified Date:
2024-07
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:
Alzheimers disease and related dementias lead to marked declines in daily functioning independence and quality of life One of the earliest cognitive changes in these conditions is impairment in prospective memory or the ability to remember future intentions such as taking medications at a given time Prior intervention studies that targeted prospective memory used mnemonic strategies or cognitive training but these approaches resulted in modest gains in clinical populations By contrast a Stage I pilot trial indicated that smartphone-based memory aids reminder apps can be accepted and used by persons with mild cognitive impairment and mild dementia to improve both subjective and objective prospective memory performance The investigators will now test for efficacy durability and generalizability of benefits across diverse samples in a Stage II randomized controlled trial Some 200 participants with mild cognitive impairment or mild dementia will be recruited half of whom will be from digitally-disadvantaged backgrounds low socioeconomic status rural or historically underrepresented groups Participants will complete baseline assessments and then be randomly assigned to a smartphone reminder app intervention or an active control condition that uses a paper- based memory support system Across a 4-week intervention period participants will complete patient-selected and experimenter-assigned prospective memory assessments and receive booster training sessions to promote self-efficacy with the interventioncontrol system Durability of effects will be assessed at 3-month and 6-month follow-up sessions As a secondary aim study partners will be simultaneously enrolled to collect informant ratings track how much study partners assist the participants and determine whether improving prospective memory in patients improves quality of life in study partners eg by reducing the double to-do list burden of remembering for themselves and for care recipients As a third aim the investigators will identify barriers and facilitators to smartphone interventions in digitally-disadvantaged individuals who have historically been underrepresented in technology and dementia research
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01AG082783-01 | NIH | None | httpsreporternihgovquickSearch1R01AG082783-01 |