The MObile AssessMENT of Behavioral and Psychological Symptoms of Dementia in Amnestic MCI and AD (MOMENT) Study

Alzheimer Disease Clinical Trial

— MOMENT  

Official title:

The MObile AssessMENT of Behavioral and Psychological Symptoms of Dementia in Amnestic Mild Cognitive Impairment and Alzheimer's Disease (MOMENT) Study: A Randomized Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04482036
• Other study ID #: 1907055854
• Secondary ID: 1K23AG059914-01A
• Status: Terminated
• Phase: N/A
• Start date: October 23, 2020
• Est. completion date: October 4, 2021

Study information

• Verified date: August 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

As a part of this research study the patient and caregiver will undergo randomization, "like flipping a coin", to assign the patient and caregiver to one of two research study groups. The patient and the partnered caregiver will join the same group. The group will either receive: 1) three in-person assessments on symptoms and behaviors that the patient may experience and a mobile application that will send surveys to the caregiver in order to rate the presence, severity and stress caused by these symptoms and behaviors; or 2) three in-person assessments on symptoms and behaviors that the patient may experience and no mobile application. The outcomes of these surveys and assessments will then be shared with the patient's clinical team.

If the caregiver is assigned to the group that receives the mobile application they will receive the surveys either weekly or monthly. After each month of completing the surveys, the frequency will change. Depending on feedback from the first 10 participants, the investigators may modify the survey rate to happen more than weekly.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: October 4, 2021
• Est. primary completion date: October 4, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

Inclusion Criteria:

• The patient:

• Has Alzheimer's Disease (AD) or Amnestic Mild Cognitive Impairment (aMCI), is a Healthy Aging Brain Center, Eskenazi Health patient

• Community dwelling

• Has a legally authorized representative when they lack capacity to consent

• The caregiver:

• 18 or older

• No visual impairment

• Community dwelling

• Reports seeing patient most days of the week

Exclusion Criteria:

• The patient:

• History of mental illness (Schizoaffective disorder, schizophrenia, bipolar)

• Participating in another study

• The potential participant with a diagnosis of either aMCI or AD communicates observable dissent.

• The caregiver:

• History of mental illness (Schizoaffective disorder, schizophrenia, bipolar)

• Participating in another study

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Dementia
• Mild Cognitive Impairment
• Mild Memory Disturbance

Intervention

Other:
• Mobile Phone Application Assessments
The BrainCare Notes app was designed to be installed on the caregiver's phone. It has the capacity to send Neuropsychiatric Inventory Questionnaire (NPI-Q) assessments to the caregiver. If the answers to the behavioral and psychological symptoms rise above the threshold, the clinicians will be notified, and a care plan will be enacted, in order to keep the patient and caregiver safe. The application also has the ability to send and receive private messages between caregiver and the patient's clinical care team.
• Standard Assessments
The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires.

Locations

Country	Name	City	State
United States	Eskenazi Health	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Outcome of the Change in the Perceived Stress Scale 14 (PSS-14) Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline.	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.	Calculated at 3 months
Other	Outcome of the Change in the Perceived Stress Scale 14 (PSS-14) Score- Specifically Any Change Seen at 6 Months From What Was Reported at Baseline.	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.	Calculated at 6 months
Other	Outcome of the Change in the Zarit Burden Interview (ZBI-12) Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline.	The ZBI-12 is a validated, caregiver self-report measure comprised of 12 items designed to assess caregiver burden in those who care for patients with advanced illness, including dementia. Participants rate items on a 5-point Likert scale, ranging from, "0 - Never" to "4 - Nearly Always." Total scores range from 0 to 48 with a higher score indicating greater caregiver burden.	Calculated at 3 months
Other	Outcome of the Change in the Zarit Burden Interview (ZBI-12) Score- Specifically Any Change Seen at 6 Months From What Was Reported at Baseline.	The ZBI-12 is a validated, caregiver self-report measure comprised of 12 items designed to assess caregiver burden in those who care for patients with advanced illness, including dementia. Participants rate items on a 5-point Likert scale, ranging from, "0 - Never" to "4 - Nearly Always." Total scores range from 0 to 48 with a higher score indicating greater caregiver burden.	Calculated at 6 months
Primary	Number of Caregivers Who Completed Neuropsychiatric Interview Questionnaire (NPI-Q) at 3 Months		Calculated at 3 months
Primary	Number of Caregivers Who Completed the Neuropsychiatric Interview Questionnaire (NPI-Q) at 6 Months		Calculated at 6 months
Primary	Number of Caregivers Who Completed the BrainCare Notes (BCN) App - Survey Burden Mean at 3 Months	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.	Calculated at 3 months
Primary	Number of Participants Who Completed the BrainCare Notes (BCN) App - Survey Burden Mean at 6 Months	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.	Calculated at 6 months
Primary	Number of Participants Who Completed the System Usability Scale (SUS) at the 3 Month Timepoint	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	Measured at 3 months
Primary	Number of Participants Who Completed the System Usability Scale (SUS) at the 6 Month Timepoint.	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	Measured at 6 months
Secondary	Outcome of the Change in Behavioral and Psychological Symptoms (BPSD) Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline.	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.	Calculated at 3 months
Secondary	Outcome of the Change in Behavioral and Psychological Symptoms (BPSD) Score- Specifically Any Change Seen at 6 Months From What Was Reported at Baseline.	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.	Calculated at 6 months
Secondary	Outcome of the Change in Caregiver Distress Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline.	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.	Calculated at 3 months
Secondary	Outcome of the Change in Caregiver Distress Score- Specifically Any Change Seen at 6 Months From What Was Reported at Baseline.	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.	Calculated at 6 months