Feasibility of the SmartPrompt for Improving Everyday Function in Dementia

NCT04313582 | Completed

• 2 other identifiers: R21AG06042224500
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Dementia; Dementia, Vascular; Dementia Alzheimers; Dementia, Mixed; Dementia, Mild; Dementia of Alzheimer Type; Mild Cognitive Impairment; Mild Dementia

Keywords

everyday function, smartphone, prompting

Outcome Measures

Primary Outcomes (14)

• Caregiver Task Completion Rating Sum of SmartPompt Condition

  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.

  2 weeks (at end SmartPrompt condition)

• Caregiver Task Completion Rating Sum of Control Condition

  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 Control Condition.

  2 weeks (at end of control condition)

• Caregiver Task Burden Sum of SmartPompt Condition

  Caregiver Reported Efficacy Variable - using a score from 0 (no burden) to 4 (severe burden), the caregiver reports the level of burden he/she experienced in helping the participant perform the two target tasks. The total possible caregiver task burden score will range from 0 - 28. A total caregiver task burden score will be calculated separately for the SmartPrompt Condition.

  2 weeks (at end of each condition)

• Caregiver Task Burden Sum of Control Condition

  Caregiver Reported Efficacy Variable - using a score from 0 (no burden) to 4 (severe burden), the caregiver reports the level of burden he/she experienced in helping the participant perform the two target tasks. The total possible caregiver task burden score will range from 0 - 28. A total caregiver task burden score will be calculated separately for the Control Condition.

  2 weeks (at end of each condition)

• Participant Activity Log Sum of SmartPompt Condition

  Participant Reported Efficacy Variable -Participant Reported Efficacy Variable - during the SmartPrompt condition participants will log a photo of their completed task (e.g., 0= task not performed or photo not logged; 1= task performed/photo logged). Failure to perform the task or log the photo will be scored as a 0. During Control condition, participants report on task completion using the same scale and a paper activity logbook. The total activity log score will range from 0 (unable to complete or log any task over one week) to 14 (completed/logged both tasks every day of the week). A total activity log score will be calculated separately for the SmartPrompt Condition.

  2 weeks (at end of each condition)

• Participant Activity Log Sum of Control Condition

  Participant Reported Efficacy Variable -Participant Reported Efficacy Variable - during the SmartPrompt condition participants will log a photo of their completed task (e.g., 0= task not performed or photo not logged; 1= task performed/photo logged). Failure to perform the task or log the photo will be scored as a 0. During Control condition, participants report on task completion using the same scale and a paper activity logbook. The total activity log score will range from 0 (unable to complete or log any task over one week) to 14 (completed/logged both tasks every day of the week). A total activity log score will be calculated separately for the Control Condition.

  2 weeks (at end of each condition)

• Participant Frustration Sum of SmartPompt Condition

  Participant Reported Efficacy Variable -Using the paper log (Control Condition) or the SmartPrompt logging feature, participants will report on their level of frustration in completing each target task using a scale from 0 (not frustrated) to 2 (very frustrated).The total possible participant frustration score will range from 0 - 28 per week for both tasks. A total participant frustration score will be calculated separately for the SmartPrompt Condition.

  2 weeks (at end of each condition)

• Participant Frustration Sum of Control Condition

  Participant Reported Efficacy Variable -Using the paper log (Control Condition) or the SmartPrompt logging feature, participants will report on their level of frustration in completing each target task using a scale from 0 (not frustrated) to 2 (very frustrated).The total possible participant frustration score will range from 0 - 28 per week for both tasks. A total participant frustration score will be calculated separately for the Control Condition.

  2 weeks (at end of each condition)

• Caregiver System Usability Scale (C-SUS)

  Caregiver Usability Measure - The C-SUS includes 10 items evaluated on a 1 (strongly disagree) - 5 (strongly agree) point scale. After correction (-1 for odd items and -5 for even, reverse-scored items), the total is multiplied by 2.5 to yield a total score ranging from 0 (poor usability) to 100 (excellent usability). The investigators also added a single seven-point adjective rating question regarding the usability of the SmartPrompt (1 = worst imaginable to 7 = best imaginable) at the end of the questionnaire to facilitate interpretation.

  2 weeks (after SmartPrompt Condition)

• Caregiver Problem Report Sum

  Caregiver Usability Measure - During the SmartPrompt testing period, the caregiver reports yes or no whether there has been any problem with the with the SmartPrompt system that day and may record a memo detailing the problem. Responses will be coded by the study team as 0 (no problem), 1 (problem affecting only 1 task), or 2 (problem affecting both tasks). A total score ranging from 0 to 28 (problem reported everyday with both tasks) as well as problem descriptions will be summed for the week.

  2 weeks (after SmartPrompt Condition)

• Technical Support Log Total

  Usability Measure from the Study Team- The study team will keep a Technical Support Log of each caregiver/participant's help request. Each problem and the number of communications over the one-week test period will be tallied.

  2 weeks (after SmartPrompt Condition)

• Total Training Time

  Usability Measure from the Study Team - the total Training Time is a measure of the length of the SmartPrompt training session, number of times the training quiz/checklist needed to be repeated during the initial training session, and whether the caregiver required additional training during the one-day phone follow-up session. The total Training Time (initial training session time + additional training time by phone) will be summed for each participant-caregiver pair. The investigators expect this variable will range from approximately 30 - 120 minutes.

  1 hour (after training)

• SmartPrompt Use Sum

  Usability Measure from Smartphone - computed from the accelerator, gyroscope, and other sensor data, as an estimate of the amount of time the smartphone was carried during the day (values will remain static if the phone was not used; higher value = more use).

  2 weeks (after SmartPrompt Condition)

• Response Time (RT) to Alarm and Prompts Average

  Usability Measure from Smartphone - Response Time (RT) to all reminder alarms and subsequent prompts (shorter RT = greater engagement).

  2 weeks (after SmartPrompt Condition)

Secondary Outcomes (2)

• Participant Open-Ended Structured Interview

  2 weeks (after SmartPrompt Condition)

• Caregiver Open-Ended Structured Interview

  2 weeks (after SmartPrompt Condition)

Study Arms (1)

SmartPrompt

EXPERIMENTAL

Behavioral: SmartPrompt smartphone application

Interventions

SmartPrompt smartphone application BEHAVIORAL

The SmartPrompt is a smartphone application designed specifically for older adults with difficulties remembering to do daily tasks due to cognitive difficulties.

Also known as: SmartPrompt

SmartPrompt

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• at least 65 years old;
• fluency in the English language;
• diagnosis of mild dementia regardless of suspected etiology consistent with McKhann et al. (2011) criteria a for "all-cause dementia" ;
• mild level cognitive impairment (i.e., Mini Mental Status Exam \> 19/30);
• 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);
• no major intellectual disability;
• no current metabolic or systemic disorders (e.g., B12 deficiency, renal failure, cancer);
• 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
• 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)
• age 18 years or older;
• fluency in the English language;
• resides with or has daily contact with the participant with dementia; and
• cognitively healthy with no diagnosis of dementia or other major health problems that would preclude reliable reporting and participation in the study.

Sponsors & Collaborators

• Temple University: lead

Study Sites (1)

Temple University

Philadelphia, Pennsylvania, 19121, United States

Location

Related Publications (1)

• Hackett 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. 2025 Apr 17:1-35. doi: 10.1080/09602011.2025.2489125. Online ahead of print.

  PMID: 40244883 DERIVED

MeSH Terms

Conditions

Dementia; Dementia, Vascular; Alzheimer Disease; Mixed Dementias; Lymphoma, Follicular; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Tauopathies; Neurodegenerative Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Cognition Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2020
• First Posted: March 18, 2020
• Study Start: March 13, 2020
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

US (1)