Clinical trial NCT06444841: Paper-Based and Smartphone-Based Memory Supports
Official title: Smartphone-Based Solutions for Prospective Memory in Mild Cognitive Impairment and Dementia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Dementia, Mild
Mild Cognitive Impairment
Lead sponsor: Baylor University
Sponsor class: OTHER
Collaborators: name: University of Texas at Austin
name: Baylor Scott and White Health
name: National Institute on Aging (NIA)
First posted: 2024-06-06
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Demonstrate capacity to consent via structured interview that involves reviewing core study features and probing for understanding of potential benefits/consequences of participating, and understanding that one can withdraw consent at any point, or availability to obtain surrogate consent.
* Clinical features consistent with a diagnosis of MCI or dementia. For clinic-referred participants, available records will be reviewed to ensure the clinical diagnosis meets published diagnostic guidelines. If there is not sufficient documentation for diagnostic purposes, then semi-structured clinical interview and cognitive screening (see below) will be reviewed by clinical staff.
* Cognitive status for inclusion will be assessed by Montreal Cognitive Assessment (MoCA) scores of 17-25 (or 12-18 for the telephone version if in-clinic assessment is not feasible). While some studies suggested that these ranges are appropriate across diverse groups, recent work indicates that adjustment of 1-2 points for different demographics improves instrument sensitivity in disadvantaged groups. The latter approach will be taken.
* Functional status will be assessed via semi-structured interview with the Global Deterioration Scale (GDS), with stage 3 or 4 indicating independence in basic self-maintenance activities.
* Adequate sensory and motor abilities to utilize a smartphone with accommodation.
* Availability of a co-participant who sees the participant at least once a month.

Co-Participant Inclusion Criteria:

* The co-participant will need to be over the age of 18, consent to participation, and see the participant at least once per month.

Exclusion Criteria:

* History of serious mental illness including schizophrenia or bipolar disorder that is judged by the clinician to be the primary cause of cognitive decline.
* Indication of moderate or severe dementia based on clinical documentation, MoCA score, and/or collateral/informant activities of daily living measure during the screening process (GDS score ≥5).
* Language difficulties significant enough to interfere with the screening procedures.
* Uncorrected hearing loss, vision loss, or motor dysfunction significant enough to interfere with training.
* No study partner.
* At the current time, individuals who do not identify as conversational in English will be excluded from participation.

Co-Participant Exclusion Criteria:

* Sees participant less than once per month.
* At the current time, individuals who do not identify as conversational in English will be excluded from participation.

Primary outcomes:
measure: Objective Prospective Memory Performance
timeFrame: Measured for 6 months
measure: Patient-Centered/Patient-Selected Prospective Memory Performance
timeFrame: Measured for 6 months
measure: Caregiving-Related Quality of Life
timeFrame: Measured for 6 months
Secondary outcomes:
measure: Caregiving Cognitive Burden
timeFrame: Measured for 6 months
measure: Calendar Use
timeFrame: Measured for 6 months
measure: Montreal Cognitive Assessment
timeFrame: Measured during screening and at 6 months
measure: Smartphone Use - Screen Time
timeFrame: Measured for 6 months
measure: Smartphone Use - Notifications
timeFrame: Measured for 6 months
measure: Smartphone Use - Pickups
timeFrame: Measured for 6 months
measure: Smartphone Use - Apps
timeFrame: Measured for 6 months
measure: Smartphone Use - Google Calendar
timeFrame: Measured for 6 months
measure: Prospective and Retrospective Memory Questionnaire - Subjective Memory Functioning
timeFrame: Measured for 6 months
measure: Modified Functional Activities Questionnaire
timeFrame: Measured for 6 months
measure: Neuro-QoL - Depression
timeFrame: Measured for 6 months
measure: Insomnia Severity Index
timeFrame: Measured for 6 months
measure: Everyday Cognition
timeFrame: Measured for 6 months
measure: General Life Satisfaction
timeFrame: Measured for 6 months
measure: Coping Self-Efficacy
timeFrame: Measured for 6 months
measure: Follow-Up Qualitative Interview
timeFrame: Measured at 6 months
measure: Training/Booster Duration
timeFrame: Measured for 1 month (throughout intervention period)
measure: Self Reported Memory Strategy Use
timeFrame: Measured for 6 months
measure: Self Reported Current Treatments
timeFrame: Measured for 6 months
Other outcomes:
Locations:
city: Austin
country: United States
facility: UT Health Austin Comprehensive Memory Center
state: Texas
city: Temple
country: United States
facility: Baylor Scott & White Healthcare
state: Texas
city: Waco
country: United States
facility: Baylor University
state: Texas
Study officials:
affiliation: Baylor University
name: Michael Scullin, PhD
role: PRINCIPAL_INVESTIGATOR
References: