Actively Recruiting
Paper-Based and Smartphone-Based Memory Supports
Led by Baylor University · Updated on 2024-07-09
200
Participants Needed
3
Research Sites
222 weeks
Total Duration
On this page
Sponsors
B
Baylor University
Lead Sponsor
U
University of Texas at Austin
Collaborating Sponsor
AI-Summary
What this Trial Is About
Alzheimer's 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 intervention/control 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 (e.g., 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.
CONDITIONS
Official Title
Paper-Based and Smartphone-Based Memory Supports
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Demonstrate capacity to consent via structured interview or have availability for surrogate consent.
- Clinical features consistent with mild cognitive impairment or dementia confirmed by records or clinical interview.
- Montreal Cognitive Assessment (MoCA) scores between 17-25 (or 12-18 for telephone assessment), adjusted for demographics.
- Functional status indicating independence in basic self-care activities (Global Deterioration Scale stage 3 or 4).
- Adequate sensory and motor skills to use a smartphone with accommodations.
- Availability of a co-participant over age 18 who sees the participant at least once a month.
- Co-participant consents to participate and sees the participant at least monthly.
You will not qualify if you...
- History of serious mental illness such as schizophrenia or bipolar disorder causing cognitive decline.
- Moderate to severe dementia indicated by clinical documentation, MoCA scores, or Global Deterioration Scale score 5 or higher.
- Significant language difficulties interfering with screening.
- Uncorrected hearing, vision loss, or motor dysfunction that affects training.
- No available study partner.
- Individuals not conversational in English are excluded.
- Co-participants who see the participant less than once per month or are not conversational in English are excluded.
AI-Screening
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Trial Site Locations
Total: 3 locations
1
UT Health Austin Comprehensive Memory Center
Austin, Texas, United States, 78712
Actively Recruiting
2
Baylor Scott & White Healthcare
Temple, Texas, United States, 76508
Not Yet Recruiting
3
Baylor University
Waco, Texas, United States, 76798
Actively Recruiting
Research Team
M
Michael Scullin, PhD
CONTACT
J
Jared Benge, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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