Paper-Based and Smartphone-Based Memory Supports
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorBaylor University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Digital - Google Calendar
BehavioralDigital calendar apps allow one to digitally "off-load" intentions either by typing them or by speaking them (speech-to-text voice-dictation capabilities). In addition, they deliver automated reminders to perform intended tasks, either at a single time (e.g., Monday at 9 am) or at recurring times (e.g., every night at 8 pm).
Paper-based - Memory Support System
BehavioralThe Memory Support System is an established paper-based solution for prospective memory functioning. There is considerable evidence in the literature for its utility in mild cognitive impairment (MCI) and it has face validity to patients as supporting memory.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Smartphone-based appExperimental treatment 1 intervention
Group B: Paper-based notebookActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Objective Prospective Memory Performance
Participants will need to remember to call the study phone number at both 1) regular times each week (set at baseline for the entire study duration), and 2) irregular times each week (experimenter-assigned times that change).
Time frame
Measured for 6 months2
Patient-Centered/Patient-Selected Prospective Memory Performance
Based on the goal attainment scaling framework; via a structured interview at baseline, the participant and study partner will identify 5-10 activities from the participant's daily routine that require frequent use of prospective memory. At follow-up sessions, participants rate the degree to which each of these personal activities improved or worsened.
Time frame
Measured for 6 months3
Caregiving-Related Quality of Life
Co-participants will complete the Direct Impact of Care (Scales Measuring the Impact of Dementia on Carers - Direct Impact) scale. This scale has 18 items to which the co-participant respond Agree or Disagree, with Agree responses indicating a greater impact of the care they provide on their own lives.
Time frame
Measured for 6 monthsSecondary outcomes
1
Caregiving Cognitive Burden
The Cognitive Burden of Caregiving Scale (CBCS) is a 14 item scale assessing cognitive burden associated with caregiving, strategy use independence and assistance, and time preoccupation. Items are responded to on a 1-7 likert scale (max score of 98) with higher scores indicating greater cognitive burden.
Time frame
Measured for 6 months2
Calendar Use
Total number of entries for the digital or paper calendar
Time frame
Measured for 6 months3
Montreal Cognitive Assessment
Participants will complete the Montreal Cognitive Assessment (MoCA), a rapid screening assessment to help detect mild cognitive impairment in numerous cognitive domains (attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation). Scores range from 0 to 30, with lower scores indicating worse outcomes.
Time frame
Measured during screening and at 6 months4
Smartphone Use - Screen Time
Participants in the digital condition will provide their total minutes of screen time from their phone's settings.
Time frame
Measured for 6 monthsSponsors and contacts
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Baylor University
Lead sponsor
University of Texas at Austin
Collaborator
Baylor Scott and White Health
Collaborator
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov