A Dyadic Telehealth Program for Alzheimer's Patients/Caregivers

July 2, 2024 updated by: Yeonsu Song, PhD, RN, FNP, University of California, Los Angeles

A Dyadic Telehealth Program to Support Alzheimer's Disease Patients and Their Caregivers During COVID-19

This study aims to refine and evaluate feasibility of a telehealth intervention for persons with Alzheimer's disease and their caregivers. The intervention will use evidence-based techniques for decreasing symptoms of depression, anxiety, and poor sleep, that are commonly reported among this vulnerable group during the COVID-19 pandemic. Improved symptoms among this group may improve their other health outcomes and quality of life and furthermore the quality of care that caregivers provide for persons with Alzheimer's disease during this challenging time.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
29

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Yeonsu Song

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Inclusion criteria for patients

  • Have a diagnosis of AD (probable or possible), other related dementia, or mild cognitive impairment as documented in electronic medical record
  • Community-dwelling
  • Aged > 50 years
  • Have no previously diagnosed sleep disorders (e.g., sleep apnea, restless legs syndrome)
  • Able to ambulate with or without assistive devices (i.e., dyads will be excluded if the care recipient is bedbound)
  • Have an eligible caregiver

Inclusion criteria for caregivers

  • Aged >18 years
  • Live with the eligible patient
  • Have regularly assisted the care recipient with >1 of 7 basic activities of daily living (ADLs; i.e., eating, dressing/undressing, grooming, walking across a room, getting in and out of bed, bathing, toileting) or >1 of 7 Instrumental ADL (IADLs; i.e., using the telephone, getting to places beyond walking distance, shopping, preparing meals, doing housework, taking medicine, handling money) for the past 6 months
  • Have no history of cognitive impairment
  • Can communicate in English.

Exclusion Criteria:

-Professional caregivers will be excluded. Patients will be excluded if they are bedbound. If the eligibility criteria for either a patient or a caregiver are not met, their dyads will be excluded for this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment group
6 weekly sleep education program
Behavioral: sleep education program
A multicomponent behavioral sleep program, consisting of sleep hygiene, stimulus control, sleep compression, pleasurable activity, daily walking, and light exposure.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sleep efficiency-Actigraphy
Time Frame: immediately after the last session of the intervention
Nighttime sleep efficiency (i.e., mean percent of time in bed spent asleep) will be calculated from 7 days of wrist actigraphy for patients and caregivers. Range from 0 to 100% with a higher percent indicating better objective sleep quality
immediately after the last session of the intervention
Pittsburgh Sleep Quality Index score
Time Frame: immediately after the last session of the intervention
Self-reported sleep quality over the past week for patients (reported by caregivers) and caregivers. Range from 0 to 21 with lower scores indicating better subjective sleep quality.
immediately after the last session of the intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total scores on the Cornell Scale for Depression in Dementia
Time Frame: immediately after the last session of the intervention
Total scores on the Cornell Scale for Depression in Dementia. Range from 0 to 38 with higher scores indicating worse depressive symptoms among persons with dementia
immediately after the last session of the intervention
Total scores on the Patient Health Questionnaire-9
Time Frame: immediately after the last session of the intervention
Total scores on the Patient Health Questionnaire-9 for caregivers. Range from from 0 to 27 with higher scores indicating worse depressive symptoms among caregivers
immediately after the last session of the intervention
Total scores on the Rating Anxiety in Dementia
Time Frame: immediately after the last session of the intervention
Total scores on the Rating Anxiety in Dementia for patients. Range from 0 to 54 with higher scores indicating worse anxiety among persons with dementia
immediately after the last session of the intervention
Total scores on the Generalized Anxiety Disorder-7
Time Frame: immediately after the last session of the intervention
Total scores on the Generalized Anxiety Disorder-7 for caregivers. Range from 0 to 21 with higher scores indicating worse anxiety among caregivers
immediately after the last session of the intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Attrition rate
Time Frame: immediately after the posttreatment assessment
Percent of number of dyads who fail to complete the study both during the intervention and at posttreatment will be measured.
immediately after the posttreatment assessment
Adherence to homework
Time Frame: immediately after the last session of the intervention
Percent of days that dyad members complete the homework over the course of the intervention program will be measured.
immediately after the last session of the intervention
Interventionist adherence
Time Frame: immediately after the last session of the intervention
Percent of completion of delivery of each component in sessions will be measured
immediately after the last session of the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 28, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 18, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 9, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • K23AG055668-04S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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