Smartphone-Based Solutions for Prospective Memory in Mild Cognitive Impairment and Dementia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- Caregiving-Related Quality of Life
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Caregiving-Related Quality of Life
时间窗: Measured for 6 months
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.
Objective Prospective Memory Performance
时间窗: Measured for 6 months
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).
Patient-Centered/Patient-Selected Prospective Memory Performance
时间窗: Measured for 6 months
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.
次要结局
- Smartphone Use - Pickups(Measured for 6 months)
- Smartphone Use - Google Calendar(Measured for 6 months)
- Caregiving Cognitive Burden(Measured for 6 months)
- Smartphone Use - Notifications(Measured for 6 months)
- Calendar Use(Measured for 6 months)
- Montreal Cognitive Assessment(Measured during screening and at 6 months)
- Smartphone Use - Screen Time(Measured for 6 months)
- Smartphone Use - Apps(Measured for 6 months)
- Neuro-QoL - Depression(Measured for 6 months)
- Prospective and Retrospective Memory Questionnaire - Subjective Memory Functioning(Measured for 6 months)
- Everyday Cognition(Measured for 6 months)
- General Life Satisfaction(Measured for 6 months)
- Training/Booster Duration(Measured for 1 month (throughout intervention period))
- Self Reported Memory Strategy Use(Measured for 6 months)
- Modified Functional Activities Questionnaire(Measured for 6 months)
- Coping Self-Efficacy(Measured for 6 months)
- Self Reported Current Treatments(Measured for 6 months)
- Insomnia Severity Index(Measured for 6 months)
- Follow-Up Qualitative Interview(Measured at 6 months)
研究者
Michael Scullin
Associate Professor of Psychology and Neuroscience
Baylor University