Clinical trial · Interventional
Feasibility of the SmartPrompt for Improving Everyday Function in Dementia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Difficulty completing everyday tasks is a primary reason for the high cost of care, loss of caregiver paid hours, and general caregiver burden associated with dementia. Electronic reminder applications hold promise as a low-cost solution to improve daily functioning, promote aging in place, and reduce caregiver burden and cost of care, particularly as older adults become more computer literate. There are many electronic reminders available for healthy individuals, but few have been developed to target the specific cognitive difficulties that impede completion of everyday tasks in people with dementia (i.e., premature decay of task goals, decreased motivation to perform tasks, distractibility, semantic knowledge degradation, etc.). Furthermore, there is a dearth of feasibility research on the fundamental efficacy and usability of reminder applications for people with dementia. This R21 proposal addresses these gaps with a feasibility study of the SmartPrompt, an enhanced electronic reminder aid designed for people with dementia that is used with an inexpensive smartphone. A diverse sample of older adults with mild dementia (N = 40) and their caregivers (N =40) will be trained to use the SmartPrompt and then asked to use the application to perform a target task (hydration, meals, or medication) twice per day in their homes for two weeks. Aim 1 will test the hypothesis that the SmartPrompt is effective at promoting everyday task completion (i.e., efficacy) relative to a one- week control period without the SmartPrompt. Using a single-group crossover design, efficacy outcomes will be obtained during the SmartPrompt and Control Conditions and will include participant and caregiver reports of task completion, caregiver report of burden, and participant report of frustration Aim 2 will investigate whether the SmartPrompt will be perceived favorably by participants and caregivers and the extent to which technical support is needed for its use (i.e., usability). Usability measures will be obtained from caregivers (report of technical problems, questionnaire), participants (questionnaire), the study team (training time, technical support required), and the smartphone (i.e., measures of smartphone use, response times to prompts). A third exploratory aim is to examine participant and caregiver features that are associated with efficacy and usability outcomes, including participant cognitive profile, participant/caregiver demographics, computer proficiency and self-efficacy, desire to change, etc. Results will be used to inform 1) a working model of barriers and facilitators for the use and efficacy of prompting applications that may be tested in future studies and 2) SmartPrompt design modifications for a future Phase II clinical trial.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dementia | — | UNRESOLVED | — |
| Dementia Alzheimers | — | UNRESOLVED | — |
| Dementia, Mild | — | UNRESOLVED | — |
| Dementia, Mixed | — | UNRESOLVED | — |
| Dementia of Alzheimer Type | — | UNRESOLVED | — |
| Dementia, Vascular | — | UNRESOLVED | — |
| Mild Cognitive Impairment | — | UNRESOLVED | — |
| Mild Dementia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SmartPrompt smartphone application | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SmartPrompt
- interventionNames
- Behavioral: SmartPrompt smartphone application
Primary outcomes (14)
- measure
- Caregiver Task Completion Rating Sum of SmartPompt Condition
- timeFrame
- 2 weeks (at end SmartPrompt condition)
- description
- Caregiver Reported Efficacy Variable - caregiver reports participant's ability to complete each of the two target tasks using the following scale (0 - failed to complete task; 1- completed the task with assistance; 2- completed the task with some difficulty; 3- no difficulty). The total possible caregiver task completion score for each task during each week will range from 0 (unable to complete the task over 7 days) to 21 no difficulty completing the task over one week). A total caregiver task completion score for both tasks (range = 0 -42) will be calculated separately for the SmartPrompt Condition.
- measure
- Caregiver Task Completion Rating Sum of Control Condition
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
The study sample will include older adults with mild dementia (N =40) and their caregivers (N=40). Inclusion/exclusion criteria for participants with dementia are as follows: 1. at least 65 years old; 2. fluency in the English language; 3. diagnosis of mild dementia regardless of suspected etiology consistent with McKhann et al. (2011) criteria a for "all-cause dementia" ; 4. mild level cognitive impairment (i.e., Mini Mental Status Exam \> 19/30); 5. availability of a caregiver (see inclusion criteria for caregiver below); 6. no lifetime history of severe psychiatric disorder (e.g., schizophrenia, bipolar disorder), nervous system infections or disorders (e.g., epilepsy, brain tumor, large-vessel stroke, major head trauma); 7. no major intellectual disability; 8. no current metabolic or systemic disorders (e.g., B12 deficiency, renal failure, cancer); 9. no severe sensory deficits that would preclude viewing a smartphone or other everyday objects or the inability to hear the task directions (e.g., blindness, total hearing loss); and 10. no severe motor weakness that would preclude the use of a smartphone or other everyday objects (e.g., severe deformities or paralysis of both upper extremities) The inclusion/exclusion criteria for caregivers are as follows: 1. age 18 years or older; 2. fluency in the English language; 3. resides with or has daily contact with the participant with dementia; and 4. cognitively healthy with no diagnosis of dementia or other major health problems that would preclude reliable reporting and participation in the study.
References
Publications (1)
- DERIVEDHackett K, McKniff M, Lehman S, Pinsky E, Tan CC, Kaplan M, Vallecorsa G, Serruya MD, Giovannetti T. A counterbalanced crossover pilot study of a personalized smartphone reminder application for older adults with cognitive impairment. Neuropsychol Rehabil. 2026 Jan;36(1):1-35. doi: 10.1080/09602011.2025.2489125. Epub 2025 Apr 17. PMID 40244883