Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Feasibility of the SmartPrompt for Improving Everyday Function in Dementia (SmartPrompt)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04313582
Recruitment Status : Recruiting
First Posted : March 18, 2020
Last Update Posted : March 18, 2020
Sponsor:
Information provided by (Responsible Party):
Temple University

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.

Condition or disease Intervention/treatment Phase
Dementia Dementia, Vascular Dementia Alzheimers Dementia, Mixed Dementia, Mild Dementia of Alzheimer Type Mild Cognitive Impairment Mild Dementia Behavioral: SmartPrompt smartphone application Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Feasibility of the SmartPrompt for Improving Everyday Function in Dementia
Actual Study Start Date : March 13, 2020
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arm Intervention/treatment
Experimental: SmartPrompt Behavioral: SmartPrompt smartphone application
The SmartPrompt is a smartphone application designed specifically for older adults with difficulties remembering to do daily tasks due to cognitive difficulties.
Other Name: SmartPrompt




Primary Outcome Measures :
  1. Caregiver Task Completion Rating Sum of SmartPompt Condition [ Time Frame: 2 weeks (at end SmartPrompt 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. Caregiver Task Completion Rating Sum of Control Condition [ Time Frame: 2 weeks (at end 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.

  3. Caregiver Task Burden Sum of SmartPompt Condition [ Time Frame: 2 weeks (at end of each 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.

  4. Caregiver Task Burden Sum of Control Condition [ Time Frame: 2 weeks (at end of each 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.

  5. Participant Activity Log Sum of SmartPompt Condition [ Time Frame: 2 weeks (at end of each 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.

  6. Participant Activity Log Sum of Control Condition [ Time Frame: 2 weeks (at end of each 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.

  7. Participant Frustration Sum of SmartPompt Condition [ Time Frame: 2 weeks (at end of each 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.

  8. Participant Frustration Sum of Control Condition [ Time Frame: 2 weeks (at end of each 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.

  9. Caregiver System Usability Scale (C-SUS) [ Time Frame: 2 weeks (after SmartPrompt Condition) ]
    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.

  10. Caregiver Problem Report Sum [ Time Frame: 2 weeks (after SmartPrompt Condition) ]
    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.

  11. Technical Support Log Total [ Time Frame: 2 weeks (after SmartPrompt Condition) ]
    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.

  12. Total Training Time [ Time Frame: 1 hour (after training) ]
    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.

  13. SmartPrompt Use Sum [ Time Frame: 2 weeks (after SmartPrompt Condition) ]
    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).

  14. Response Time (RT) to Alarm and Prompts Average [ Time Frame: 2 weeks (after SmartPrompt Condition) ]
    Usability Measure from Smartphone - Response Time (RT) to all reminder alarms and subsequent prompts (shorter RT = greater engagement).


Secondary Outcome Measures :
  1. Participant Open-Ended Structured Interview [ Time Frame: 2 weeks (after SmartPrompt Condition) ]
    Participant Usability Measure- participant is asked open-ended questions about the SmartPrompt design and usability.

  2. Caregiver Open-Ended Structured Interview [ Time Frame: 2 weeks (after SmartPrompt Condition) ]
    Caregiver Usability Measure- caregiver is asked open-ended questions about the SmartPrompt design and usability.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04313582


Contacts
Layout table for location contacts
Contact: Tania Giovannetti, PhD 2152044296 tgio@temple.edu

Locations
Layout table for location information
United States, Pennsylvania
Temple University Recruiting
Philadelphia, Pennsylvania, United States, 19121
Contact: Tania Giovannetti, Ph.D.    215-204-4296    tgio@temple.edu   
Sponsors and Collaborators
Temple University
Layout table for additonal information
Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT04313582    
Other Study ID Numbers: R21AG060422 ( U.S. NIH Grant/Contract )
24500 ( Other Identifier: Temple IRB protocol number )
First Posted: March 18, 2020    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Temple University:
everyday function, smartphone, prompting
Additional relevant MeSH terms:
Layout table for MeSH terms
Dementia
Alzheimer Disease
Dementia, Vascular
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Tauopathies
Neurodegenerative Diseases
Cognition Disorders
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Leukoencephalopathies
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases