Who is sponsoring NCT04536701?

NCT04536701 is sponsored by Ohio State University.

What drugs are being tested in NCT04536701?

Interventions in NCT04536701: Mood Monitoring and Behavioral Recommendation System.

What condition does NCT04536701 study?

NCT04536701 studies Alzheimer Disease, Caregiver Stress Syndrome.

Is NCT04536701 still recruiting?

NCT04536701 is currently completed. Last updated 6 May 2025.

Are results published for NCT04536701?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-05-06 · How we verify

NCT04536701

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Learning and Improving Alzheimer's Patient-Caregiver Relationships Via Smart Healthcare Technology

Completed NA Results posted Last updated 6 May 2025

What this trial tests

NA trial testing Mood Monitoring and Behavioral Recommendation System in Alzheimer Disease in 22 participants. Completed in 31 December 2024.

Timeline

19 February 2021

Primary endpoint
31 December 2023

31 December 2024

Quick facts

Lead sponsor	Ohio State University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	22
Start date	19 February 2021
Primary completion	31 December 2023
Estimated completion	31 December 2024
Sites	1 location across United States

Drugs / interventions tested

Mood Monitoring and Behavioral Recommendation System

Conditions studied

Alzheimer Disease — all drugs for Alzheimer Disease →
Caregiver Stress Syndrome — all drugs for Caregiver Stress Syndrome →

Sponsor

Ohio State University

Who can join

Adults 21 to 99, any sex, with Alzheimer Disease or Caregiver Stress Syndrome. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Depression Anxiety Stress Scale (DASS) Primary · Baseline, 4 months

The DASS is a set of three self-report scales designed to measure the negative emotional states of depression, anxiety and stress in 3 subscales of 14 items each. The scores of each subscale range from 0-42. These subscales are scored by the addition of the total item scores. Total score is obtained by summing all subscores. Total minimum score: 0; Total maximum score: 126; A higher score indicates higher levels of emotional distress, depression, anxiety and stress. Total: Normal - 0-32; Mild - 33-39; Moderate - 40-49; Severe - 50-57; Extremely severe - 58+ Depression: Normal - 0-9; Mild -10

Total

Group	Value	95% CI
Baseline - Dementia/Caregiver Dyad	26.27	± 16.46
4 Months Post Baseline - Dementia/Caregiver Dyad	29.10	± 30.29

DASS-Depressive mood

Group	Value	95% CI
Baseline - Dementia/Caregiver Dyad	8.09	± 5.39
4 Months Post Baseline - Dementia/Caregiver Dyad	10	± 10.35

DASS-Anxiety

Group	Value	95% CI
Baseline - Dementia/Caregiver Dyad	6	± 5.25
4 Months Post Baseline - Dementia/Caregiver Dyad	6.5	± 9.23

DASS-Stress

Group	Value	95% CI
Baseline - Dementia/Caregiver Dyad	12.18	± 7.31
4 Months Post Baseline - Dementia/Caregiver Dyad	12.6	± 11.74

Revised Memory and Behavior Problems Checklist (RMBPC) Primary · Baseline, 4 months

RMBPC 24-item, caregiver-report of observable behavioral problems in dementia patients AND the caregiver's stress reactions to these disturbances. It provides a total score and 3 subscale scores (memory, depression, and disruptive behaviors) and scores for caregiver reactions. Score ranges - Frequency: Total 0-96; Disruptive 0-32; Depressive 0-36; Memory 0-24. Sum items with scores of 0 to 4 on subscales and total. If question score is 9, exclude it from the sum and item count. Sum items for each subscale, compute the mean item score for each subscale by dividing by the number of items includ

Frequency of Symptoms Total

Group	Value	95% CI
Baseline - Dementia/Caregiver Dyad	13.27	± 4.22
4 Months Post Baseline - Dementia/Caregiver Dyad	10.9	± 5.47

Frequency of Disruptive Symptoms

Group	Value	95% CI
Baseline - Dementia/Caregiver Dyad	3.82	± 2.60
4 Months Post Baseline - Dementia/Caregiver Dyad	2.4	± 2.95

Frequency of Depressive Symptoms

Group	Value	95% CI
Baseline - Dementia/Caregiver Dyad	3.09	± 2.59
4 Months Post Baseline - Dementia/Caregiver Dyad	2.1	± 2.38

Frequency of Memory Symptoms

Group	Value	95% CI
Baseline - Dementia/Caregiver Dyad	6.36	± 0.92
4 Months Post Baseline - Dementia/Caregiver Dyad	6.4	± 0.84

Reaction to Symptoms Total

Group	Value	95% CI
Baseline - Dementia/Caregiver Dyad	26.82	± 17.35
4 Months Post Baseline - Dementia/Caregiver Dyad	19.6	± 21.90

Reaction to Disruptive Symptoms

Group	Value	95% CI
Baseline - Dementia/Caregiver Dyad	9.45	± 7.50
4 Months Post Baseline - Dementia/Caregiver Dyad	5.5	± 7.53

Reaction to Depressive Symptoms

Group	Value	95% CI
Baseline - Dementia/Caregiver Dyad	7.27	± 8.26
4 Months Post Baseline - Dementia/Caregiver Dyad	5	± 8.41

Reaction to Memory Symptoms

Group	Value	95% CI
Baseline - Dementia/Caregiver Dyad	10.09	± 6.00
4 Months Post Baseline - Dementia/Caregiver Dyad	9.1	± 7.19

Change in Caregiver Emotional Reactivity Primary · Baseline, 4 months

The 16-item, Difficulties in Emotion Regulation Scale (DERS-16) will be used to measure caregivers' ability to regulate emotions at baseline and end of study. The scale used is the brief version of a theoretically-driven, valid, and reliable self-report tool used to measure difficulties with emotion regulation. The brief version will be more easily administered with the study population and has been shown to be valid and reliable \[41\]. Minimum score: 16; Maximum score: 80. A higher score indicates higher levels of caregiver emotional reactivity.

Group	Value	95% CI
Baseline - Dementia/Caregiver Dyad	30.55	± 11.85
4 Months Post Baseline - Dementia/Caregiver Dyad	34.3	± 15.70

Five Facet Mindfulness Questionnaire Primary · Baseline, 4 months

Five Facet Mindfulness Questionnaire 39-item to measure capacity for five different domains of mindfulness practice at baseline and end of study. The five facets include non-reactivity to the inner experience, non-judgment of the inner experience, acting with awareness, observing, and describing internal states. All items are scored with a scale of 1-5. Some items are marked to be reverse scored. All items are scored and summed then divided by the total in each category by the number of items in that category to get an average category score. Each category is summed to calculate the Total then

Total

Group	Value	95% CI
Baseline - Dementia/Caregiver Dyad	3.48	± 0.58
4 Months Post Baseline - Dementia/Caregiver Dyad	3.44	± 0.49

Observing

Group	Value	95% CI
Baseline - Dementia/Caregiver Dyad	3.43	± 0.93
4 Months Post Baseline - Dementia/Caregiver Dyad	3.44	± 0.96

Describing

Group	Value	95% CI
Baseline - Dementia/Caregiver Dyad	3.83	± 0.56
4 Months Post Baseline - Dementia/Caregiver Dyad	3.71	± 0.61

Acting with Awareness

Group	Value	95% CI
Baseline - Dementia/Caregiver Dyad	3.17	± 0.90
4 Months Post Baseline - Dementia/Caregiver Dyad	3.23	± 1.14

Non-judging

Group	Value	95% CI
Baseline - Dementia/Caregiver Dyad	3.55	± 0.91
4 Months Post Baseline - Dementia/Caregiver Dyad	3.58	± 0.98

Nonreactivity

Group	Value	95% CI
Baseline - Dementia/Caregiver Dyad	3.42	± 0.84
4 Months Post Baseline - Dementia/Caregiver Dyad	3.21	± 0.77

Change in Caregiver Strain Primary · Baseline, 4 months

Modified Caregiver Strain Index (MCSI): It is a 13-item self-report measure that examines both subjective and objective elements of caregiver strain. The MCSI showed excellent inter-item and test-retest reliability and was correlated in expected directions with relevant criteria \[32\]. It has excellent reliability and validity, displays adequate clinical sensitivity, has an established cut-off for determining functional/dysfunctional systems, and has been used successfully on a variety of mental health outcomes \[28\]. We will use a practice tracking worksheet to assess how much the caregiver

Group	Value	95% CI
Baseline - Dementia/Caregiver Dyad	14.18	± 5.58
4 Months Post Baseline - Dementia/Caregiver Dyad	15.1	± 6.84

Family Assessment Device (FAD) Primary · Baseline, 4 months

The FAD is a self-report measure that is given as a set of seven subscales measuring a different dimension of family function. Scores for each dimension (problem solving, communication, roles, affective responsiveness, affective involvement, behavior control, and general functioning) are calculated separately as the mean of the items in that subscale. Scored by summing the endorsed responses (1-4) for each subscale (negatively worded statements are reversed) and dividing by the number of items in each scale. A higher score indicates greater levels of family functioning on all subscales Score

FAD Total

Group	Value	95% CI
Baseline - Dementia/Caregiver Dyad	2.13	± 0.46
4 Months Post Baseline - Dementia/Caregiver Dyad	2.20	± 0.59

FAD Problem Solving

Group	Value	95% CI
Baseline - Dementia/Caregiver Dyad	2.15	± 0.49
4 Months Post Baseline - Dementia/Caregiver Dyad	2.32	± 0.73

FAD Communication

Group	Value	95% CI
Baseline - Dementia/Caregiver Dyad	2.29	± 0.56
4 Months Post Baseline - Dementia/Caregiver Dyad	2.23	± 0.49

FAD Roles

Group	Value	95% CI
Baseline - Dementia/Caregiver Dyad	2.29	± 0.40
4 Months Post Baseline - Dementia/Caregiver Dyad	2.35	± 0.72

FAD Affective Responsiveness

Group	Value	95% CI
Baseline - Dementia/Caregiver Dyad	2.27	± 0.62
4 Months Post Baseline - Dementia/Caregiver Dyad	2.35	± 0.76

FAD Affective Involvement

Group	Value	95% CI
Baseline - Dementia/Caregiver Dyad	2.08	± 0.43
4 Months Post Baseline - Dementia/Caregiver Dyad	2.20	± 0.59

FAD Behavior Control

Group	Value	95% CI
Baseline - Dementia/Caregiver Dyad	1.82	± 0.49
4 Months Post Baseline - Dementia/Caregiver Dyad	1.91	± 0.52

FAD General Functioning

Group	Value	95% CI
Baseline - Dementia/Caregiver Dyad	2.05	± 0.72
4 Months Post Baseline - Dementia/Caregiver Dyad	2.07	± 0.77

Sponsor's own description

The purpose of this project is to develop a monitoring, modeling, and interactive recommendation solution (for caregivers) for in-home dementia patient care that focuses on caregiver-patient relationships. This includes monitoring for mood and stress and analyzing the significance of monitoring those attributes to dementia patient care and subsequent behavior dynamics between the patient and caregiver. In addition, novel and adaptive behavioral suggestions at the right moments aims at helping improve familial interactions related to caregiving, which over time should ameliorate the stressful effects of the patient's illness and reduce strain on caregivers. The technical solution consists of a core set of statistical learning based techniques for automated generation of specialized modules required by in-home dementia patient care. There are three main technical components in the solution. The first obtains textual content and prosody from voice and uses advanced machine learning techniques to create classification models. This approach not only monitors patients' behavior, but also caregivers', and infers the underlying dynamics of their interactions, such as changes in mood and stress. The second is the automated creation of classifiers and inference modules tailored to the particular patients and dementia conditions (such as different stages of dementia). The third is an adaptive recommendation system that closes the loop of an in-home behavior monitoring system.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Smarthealth technology study protocol to improve relationships between older adults with dementia and family caregivers.
Rose KM, Coop Gordon K, Schlegel EC, Mccall M, et al · · 2021 · cited 6× · PMID 33576064 · DOI 10.1111/jan.14714
Recruitment Challenges and Strategies in a Technology-Based Intervention for Dementia Caregivers: Descriptive Study.
Ko E, Gao Y, Wang P, Wijayasingha L, et al · · 2025 · cited 2× · PMID 39864818 · DOI 10.2196/59291
Feasibility and Acceptability of the Smarthealth Intervention for Dementia Caregivers. A Qualitative Analysis of a Single-Group Pilot Study.
Ko E, Rose KM, Gordon KC, Kim S, et al · · 2026 · PMID 40566925 · DOI 10.1111/jan.70007

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04536701 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Ohio State University
Last refreshed: 6 May 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04536701.

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