Clinical trial NCT04510883: Usage and Health Effects of Embodied Conversational Agents Among Older Adults
Official title: Usage and Health Effects of Embodied Conversational Agents Among Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Behavior
Loneliness
Technology Use
Keywords: eHealth
Embodied Conversational Agent
Technology use
Lead sponsor: Wageningen University and Research
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
name: WAAG
name: Roessingh Research and Development
name: National Foundation for the Elderly
First posted: 2020-08-12
Enrollment: 52
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: An unblinded randomized controlled trial. Participants in the first cohort directly receive the intervention for 8 weeks. Participants in the second cohort receive the intervention after a waiting list condition of 4 weeks, serving as a control group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Rationale: Embodied Conversational Agents (ECAs), could be a highly effective medium to address health behaviour change among older adults. As compliance to health advice is important for positive health outcomes, successful design of persuasive ECAs can have huge health benefits. However, insights in the mechanisms underlying usage and health behaviour change via ECAs are lacking.

Objective: The objective is to unravel the mechanisms behind the use of an ECA intervention, and understand the mechanism behind the observed behaviour change

Study design: A randomized staggered-entry waitlist-controlled trial will be carried out.

Study population: The study population consist of Dutch-speaking older adults, who live independently, are without partner, are retired, 65+ and possess basic computer skills.

Intervention: The application PACO has been created for (and with) older adults with the goal to motivate them to improve their eating behaviour and decrease their feelings of loneliness.

Main study parameters/endpoints: The main study parameters are use, loneliness, and eating behaviour.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects are not exposed to any risks, nor have they any costs. They do have to fill in questionnaires and use the application. The duration and data collection moments are needed to gain a fine-grained understanding of the use, relationship development and health change process. For subjects, the main benefit is to gain insight in their health behaviour via the PACO-application. Although this might be experienced as confronting by some. The technology was developed based on sound theories, with input from the target group, so the investigators expect positive experiences and an improvement in participants loneliness and eating behaviour. However, this can only be proven after the study.


Eligibility criteria: Inclusion Criteria:

* Living independently at home
* Living without a partner
* No paid profession and at least 65 years of age
* Dutch speaking
* Able to use a tablet or computer
* Internet connection at home

Exclusion Criteria:

* Not willing to provide inform consent

Primary outcomes:
measure: Logdata on use application
timeFrame: 8 weeks
measure: Change in De Jong Gierveld Loneliness Scale
timeFrame: Four weeks before intervention to eight weeks
measure: Change in eating behaviour based on 24 hours recall
timeFrame: Four weeks before intervention to eight weeks
Secondary outcomes:
measure: Enjoyment via affect scale
timeFrame: Eight weeks after intervention
measure: Classic aesthetics Scale
timeFrame: Eight weeks after intervention
measure: Concern for privacy scale
timeFrame: Four and eight weeks after intervention
measure: Active control scale
timeFrame: Eight weeks after intervention
measure: System Usability Scale
timeFrame: Eight weeks after intervention
measure: Perceived usefulness scale
timeFrame: Eight weeks after intervention
measure: Rapport scale
timeFrame: Four weeks before intervention to eight weeks
measure: Brief Older People's Quality of Life Scake
timeFrame: Four weeks before intervention to eight weeks
measure: Change in Basic Psychological Need Satisfaction and Frustration Scales
timeFrame: Four weeks before intervention to eight weeks
Other outcomes:
measure: Willingness to pay single questions
timeFrame: Eight weeks after intervention
measure: User experience via self-formulated open question
timeFrame: Four and eight weeks after intervention
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen University & Research
state: Gelderland
Study officials:
affiliation: Wageningen University & Research
name: Emely de Vet, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kramer LL, van Velsen L, Clark JL, Mulder BC, de Vet E. Use and Effect of Embodied Conversational Agents for Improving Eating Behavior and Decreasing Loneliness Among Community-Dwelling Older Adults: Randomized Controlled Trial. JMIR Form Res. 2022 Apr 11;6(4):e33974. doi: 10.2196/33974.
citation: Kramer LL, Mulder BC, van Velsen L, de Vet E. Use and Effect of Web-Based Embodied Conversational Agents for Improving Eating Behavior and Decreasing Loneliness Among Community-Dwelling Older Adults: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Jan 6;10(1):e22186. doi: 10.2196/22186.