NCT03308032

Brief Summary

The proposed project seeks to develop an online self-directed learning (SDL) intervention program that seeks to improve caregiving and self-care skills among ethnic Chinese dementia caregivers. The benefits of such a product may include improved psychological health in caregivers and a reduction in behavioral disturbances among elderly care recipients with dementia.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 12, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2018

Completed
Last Updated

October 12, 2017

Status Verified

October 1, 2017

Enrollment Period

1.5 years

First QC Date

October 3, 2017

Last Update Submit

October 11, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Stress Level

    Will be assessed using the 10 point Perceived Stress Scale

    At Week 1 and at Week 12

Study Arms (2)

Intervention

EXPERIMENTAL

Participants assigned to the intervention arm will be invited to connect to a webpage, through either computer or tablet / iPad, where they can login to receive the SDL course. Immediately after the login, and weekly thereafter, participants will receive emails to remind them of the login passwords, to provide them with tracking data on their progress in going through the training lessons. For those who login but do not proceed to take baseline assessment for longer than two days, study staff will contact participants, via the email address or telephone number that was entered during initial registration for login, to answer any questions they might have and to provide assistance to those who have not been able to log onto the site. Those who sign up without taking any courses for 10 days will receive a reminder call by study staff. Intervention arm participants will be invited back via both

Behavioral: Intervention

Control

ACTIVE COMPARATOR

Participants assigned to the intervention arm will be invited to connect to a webpage, through either computer or tablet / iPad, where they can login to receive the SDL course. Immediately after the login, and weekly thereafter, participants will receive emails to remind them of the login passwords, to provide them with tracking data on their progress in going through the training lessons (see below). For those who login but do not proceed to take baseline assessment for longer than two days, study staff will contact participants, via the email address or telephone number that was entered during initial registration for login, to answer any questions they might have and to provide assistance to those who have not been able to log onto the site. Those who sign up without taking any courses for 10 days will receive a reminder call by study staff. Intervention arm participants will be invited back via both

Behavioral: Control

Interventions

InterventionBEHAVIORAL

SDL intervention employs a comprehensive engagement design that includes seven innovative strategies: 1) customization of content of the training curriculum to fit individual learner's needs; 2) tailoring the length of trainings by using short video clips to allow caregivers flexibility in completing the curriculum; 3) using an instructional format (SCHOLAR) designed to maximize active learning during each training lesson; 4) progress tracking to help the learner stay focused and motivated; 5) a recommendation algorithm that facilitates the learner's transition from one training topic to the next; 6) behavioral economics-based messages, to re-engage the learner if he/she stops participating

Intervention
ControlBEHAVIORAL

Participants in the control group will be invited to a comparable online training course consisting of all of our training video clips, without the interactive engagement design features. These represent standard video training based on evidence-based content.

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ethnic Chinese Caregiver

You may not qualify if:

  • Not Chinese or Caregiver

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

DementiaAlzheimer Disease

Interventions

Methods

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersTauopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2017

First Posted

October 12, 2017

Study Start

September 1, 2016

Primary Completion

March 5, 2018

Study Completion

July 30, 2018

Last Updated

October 12, 2017

Record last verified: 2017-10