SAMi Intervention Study to Evaluate Smartwatch Interventions in Persons

Status Completed

Clinical Trial Summary

Assistive Technologies (ATs) can help people living with dementia (PwD) maintain their everyday activity. Still, there is a gap between potential and supply. Involving future users can close the gap. But the value of participation from PwD is unclear. The study examined smartwatch interactions from people with dementia or with mild cognitive impairment. Participants received "regularly" (n=20) or "intensively" (n=20) intrusive audio-visual prompts on a customized smartwatch to perform everyday tasks. Participants' reactions were observed via cameras. Users' feedback was captured with questionnaires.

Clinical Trial Description

This was a mixed methods study involving different stakeholder groups in a stepwise approach towards the user-centered evaluation of a smartwatch-based application for PwD. A preparatory qualitative study focused on identifying needs and requirements for mobile assistive devices. An observatory field study revealed potential use cases for smartwatches for persons with dementia. The subsequent intervention study examined smartwatch interactions and gathered users' feedback concerning usability, design, usefulness and concerns. Participants with mild cognitive impairment or dementia received either "regularly" (n=20) or "intensively" (n=20) intrusive audio-visual prompts to perform everyday tasks. All participants were prompted to complete two tasks, prompts were repeated up to three times if they failed to completely solve a task. Prompts were triggered using a smartphone as remote control. Patient reactions were observed via video cameras. Each task was rated with 1 point for success, 0.5 for incomplete task fulfillment or 0 for failure. Both tasks were summarized, resulting in success values from 0 to 2 points. Abbreviations: PwD: people with dementia MCI: mild cognitive impairment AT: assistive technology ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05885620
Study type	Interventional
Source	University of Rostock
Contact
Status	Completed
Phase	N/A
Start date	November 10, 2020
Completion date	November 10, 2022

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04044495` - Sleep, Rhythms and Risk of Alzheimer's Disease	N/A
Completed	`NCT04079803` - PTI-125 for Mild-to-moderate Alzheimer's Disease Patients	Phase 2
Terminated	`NCT03052712` - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies	N/A
Recruiting	`NCT04520698` - Utilizing Palliative Leaders In Facilities to Transform Care for Alzheimer's Disease	N/A
Active, not recruiting	`NCT04606420` - Can Lifestyle Changes Reverse Early-Stage Alzheimer's Disease	N/A
Recruiting	`NCT05820919` - Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase	N/A
Terminated	`NCT03672474` - REGEnLIFE RGn530 - Feasibility Pilot	N/A
Completed	`NCT03430648` - Is Tau Protein Linked to Mobility Function?
Recruiting	`NCT04522739` - Spironolactone Safety in African Americans With Mild Cognitive Impairment and Early Alzheimer's Disease	Phase 4
Recruiting	`NCT05557409` - A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation	Phase 3
Recruiting	`NCT04949750` - Efficacy of Paper-based Cognitive Training in Vietnamese Patients With Early Alzheimer's Disease	N/A
Recruiting	`NCT05288842` - Tanycytes in Alzheimer's Disease and Frontotemporal Dementia
Completed	`NCT06194552` - A Multiple Dose Study of the Safety and Pharmacokinetics of NTRX-07	Phase 1
Completed	`NCT03239561` - Evaluation of Tau Protein in the Brain of Participants With Alzheimer's Disease Compared to Healthy Participants	Early Phase 1
Completed	`NCT03184467` - Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Alzheimer Patients	Phase 2
Active, not recruiting	`NCT03676881` - Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
Terminated	`NCT03487380` - Taxonomic and Functional Composition of the Intestinal Microbiome: a Predictor of Rapid Cognitive Decline in Patients With Alzheimer's Disease	N/A
Completed	`NCT05538455` - Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases	N/A
Recruiting	`NCT05328115` - A Study on the Safety, Tolerability and Immunogenicity of ALZ-101 in Participants With Early Alzheimer's Disease	Phase 1
Completed	`NCT05562583` - SAGE-LEAF: Reducing Burden in Alzheimer's Disease Caregivers Through Positive Emotion Regulation and Virtual Support	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

SAMi Intervention Study to Evaluate Smartwatch Interventions in Persons With MCI and Dementia — SAIN_UMR

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms