Self-Directed Online Training for Chinese Caregivers

Alzheimer Disease Clinical Trial

Official title:

Self-Directed Online Training for Chinese Caregivers

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03308032
• Other study ID #: NIH 1R43HL115924-01
• Status: Enrolling by invitation
• Phase: N/A
• First received: October 3, 2017
• Last updated: October 11, 2017
• Start date: September 1, 2016
• Est. completion date: July 30, 2018

Study information

• Verified date: October 2017
• Source: Environment and Health Group, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The objective of this Phase II application is 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. While online dementia caregiver interventions are advantageous in reaching broad audiences, these individuals face significant challenges in engaging the target audience and keeping them engaged throughout the intervention program. The proposed online SDL skill training intervention addresses these challenges with a comprehensive engagement design to ensure retention and effective learning in the training program.

All Phase I Study Aims have been successfully completed. The prototype provides preliminary evidence that an SDL training intervention is able to successfully engage ethnic Chinese caregivers of elders with dementia, improving perceived self-efficacy to manage caregiving tasks, while reducing negative emotions in the caregiver. Phase II Specific Aims: The Phase II study will further develop the prototype into a fully-functioning online SDL skill training intervention for ethnic Chinese dementia caregivers, and evaluate it in a randomized control trial. In Specific Aim 1, the research team will develop additional multi-lingual training video clips to complete the training program, and make them available for Cantonese-, Mandarin-, and/or English-speaking caregivers from different Chinese cultural backgrounds. In Specific Aim 2, the research team will develop software that enables and integrates all engagement design functionalities. In Specific Aim 3, the research team will conduct a randomized controlled trial to evaluate the effectiveness of the SDL training intervention based on a comprehensive engagement design (intervention arm) compared to one that does not rely on a comprehensive engagement design (control arm).

Evidence of the effectiveness of the SDL intervention will contribute to the larger information and communication technology field, increasing the public's understanding and basic knowledge of effective engagement in the rapidly growing field of online health interventions. The comprehensive engagement approach developed through this research could be transferred to other ethnic minority groups facing dementia caregiving challenges, as well as other populations facing challenges related to the management of other chronic conditions.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 120
• Est. completion date: July 30, 2018
• Est. primary completion date: March 5, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Ethnic Chinese Caregiver

Exclusion Criteria:

• Not Chinese or Caregiver

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia

Intervention

Behavioral:
• Intervention
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
• Control
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Environment and Health Group, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Stress Level	Will be assessed using the 10 point Perceived Stress Scale	At Week 1 and at Week 12