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The MObile AssessMENT of Behavioral and Psychological Symptoms of Dementia in Amnestic MCI and AD (MOMENT) Study
NA trial testing Mobile Phone Application Assessments in Alzheimer Disease in 20 participants. Terminated before completion.
| Lead sponsor | Indiana University |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | supportive care |
| Enrollment | 20 |
| Start date | 23 October 2020 |
| Primary completion | 4 October 2021 |
| Estimated completion | 4 October 2021 |
| Sites | 1 location across United States |
Indiana University
Adults 18 to 120, any sex, with Alzheimer Disease or Mild Memory Disturbance. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
| Group | Value | 95% CI |
|---|---|---|
| Control - Dementia Collaborative Care - Caregivers | 3 | |
| Randomized - Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers | 4 |
| Group | Value | 95% CI |
|---|---|---|
| Randomized - Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers | 2 |
Randomized participants are prompted to answer the survey burden question after completion of each BCN app prompted survey. The caregivers in the control group, "Dementia Collaborative Care- Caregivers" did not utilize the BrainCare Notes application.
| Group | Value | 95% CI |
|---|---|---|
| Control- Dementia Collaborative Care - Caregivers | 0 | |
| Randomized - Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers | 4 |
Randomized participants are prompted to answer the survey burden question after completion of each BCN app prompted survey. The caregivers in the control group, "Dementia Collaborative Care- Caregivers" did not utilize the BrainCare Notes application.
| Group | Value | 95% CI |
|---|---|---|
| Control - Dementia Collaborative Care - Caregivers | 0 | |
| Randomized - Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers | 2 |
The System Usability Scale will be used to assess usability of the BrainCare Notes app at 3 months. Only the randomized participants will be completing this survey. The scale is as follows: Strongly Disagree-1, Disagree- 2, Neutral- 3, Agree- 4, Strongly Agree- 5
| Group | Value | 95% CI |
|---|---|---|
| Randomized - Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers | 4 |
The System Usability Scale (SUS) will be used to assess usability of the BrainCare Notes app at 6 months. Only the randomized participants will be completing this survey. The scale is as follows: Strongly Disagree-1, Disagree- 2, Neutral- 3, Agree- 4, Strongly Agree- 5
| Group | Value | 95% CI |
|---|---|---|
| Randomized - Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers | 2 |
The NPI-Q is a questionnaire administered to a caregiver who cares for a person with mild cognitive impairment (MCI), Alzheimer's disease (AD) or dementia. Symptom severity scores for each of the symptom domain range between 0-not present, 1 - mild, 2-moderate, 3-severe. The summation of all symptom severity scores have a range of a minimum score of 0 and maximum score of 36, where the higher the number indicates worse symptom severity.
| Group | Value | 95% CI |
|---|---|---|
| Dementia Collaborative Care - Caregivers | 0.33 | -4 – 7 |
| Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers | 1 | -7 – 8 |
The NPI-Q is a questionnaire administered to a caregiver who cares for a person with mild cognitive impairment (MCI), Alzheimer's disease (AD) or dementia. Symptom severity scores for each of the symptom domain range between 0-not present, 1 - mild, 2-moderate, 3-severe. The summation of all symptom severity scores have a range of a minimum score of 0 and maximum score of 36, where the higher the number indicates worse symptom severity.
| Group | Value | 95% CI |
|---|---|---|
| Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers | 6 | 2 – 10 |
The NPI-Q is a questionnaire administered to the caregiver who cares for a person with mild cognitive impairment (MCI), Alzheimer's disease (AD) or dementia. The Caregiver Distress scores for each of the symptom domain range between: 0 = Not distressing at all, 1 = Minimal, 2 = Mild, 3 = Moderate, 4 = Severe, 5 = Extreme or Very Severe. The summation of all the Caregiver Distress scores ranges from a min score of 0 and max score of 60, where the higher the number indicates worse Caregiver Distress severity.
| Group | Value | 95% CI |
|---|---|---|
| Dementia Collaborative Care - Caregivers | 0.33 | -4 – 7 |
| Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers | 4.25 | -11 – 14 |
The NPI-Q is a questionnaire administered to the caregiver who cares for a person with mild cognitive impairment (MCI), Alzheimer's disease (AD) or dementia. The Caregiver Distress scores for each of the symptom domain range between: 0 = Not distressing at all, 1 = Minimal, 2 = Mild, 3 = Moderate, 4 = Severe, 5 = Extreme or Very Severe. The summation of all the Caregiver Distress scores ranges from a min score of 0 and max score of 60, where the higher the number indicates worse Caregiver Distress severity.
| Group | Value | 95% CI |
|---|---|---|
| Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers | -3.5 | -9 – 2 |
The PSS-14 is a validated self-reported questionnaire comprised of 14 items designed to assess stress and coping. Participants rate items on a 5-point Likert scale, ranging from 0 - "Never" to 4" Very often." Total scores range from 0 to 56 with a higher score indicating greater perceived stress.
| Group | Value | 95% CI |
|---|---|---|
| Dementia Collaborative Care - Caregivers | -1 | -7 – 6 |
| Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers | -3.67 | -6 – -1 |
The PSS-14 is a validated self-reported questionnaire comprised of 14 items designed to assess stress and coping. Participants rate items on a 5-point Likert scale, ranging from 0 - "Never" to 4" Very often." Total scores range from 0 to 56 with a higher score indicating greater perceived stress.
| Group | Value | 95% CI |
|---|---|---|
| Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers | 3 | 1 – 5 |
Time frame: 6 months. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Dementia Collaborative Car… | Dementia Collaborative Car… | Dementia Collaborative Car… | Dementia Collaborative Car… |
|---|---|---|---|---|---|
| Death | General disorders | — | — | — | — |
| Hospitalization | Cardiac disorders | — | — | — | — |
| Reaction | System | Dementia Collaborative Car… | Dementia Collaborative Car… | Dementia Collaborative Car… | Dementia Collaborative Car… |
|---|---|---|---|---|---|
| Pacemaker insertion | Cardiac disorders | — | — | — | — |
Most-reported serious reactions: Death, Hospitalization.
Data from ClinicalTrials.gov NCT04482036 adverse events section.
The purpose of this research study is to learn whether it is possible and useful for caregivers to report behavioral or psychological symptoms of people with mild memory problems or Alzheimer's disease through a smartphone mobile application. The investigators believe that monitoring these symptoms and having a tool, like a mobile application, can provide quicker accessibility to the patient's clinical care team, which could improve care for patients and caregivers. These types of symptoms found in patients with mild memory problems or Alzheimer's disease are any type of psychiatric symptoms or abnormal behaviors one might develop as the result of these brain illnesses. Examples of psychological and behavioral symptoms are depression, anxiety, insomnia, irritability, agitation, and hallucinations. These symptoms differ from regular psychiatric symptoms, because they are caused by mild memory problems or Alzheimer's disease (AD). These symptoms can cause a lot of distress for patients and caregivers, and can lead to greater use of healthcare services.
No peer-reviewed publications indexed yet for this trial.
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