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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
| WAAG | UNKNOWN |
| Roessingh Research and Development | OTHER |
| National Foundation for the Elderly |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PACO | Experimental | Participants are asked to use the intervention for eight weeks. |
|
| Waiting list + PACO | Other | Participants receive the same intervention, but only after a waiting period of four weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PACO | Behavioral | The intervention is a fully-automated web-based eHealth application in which two embodied conversational agents engage in dialogue with older adults in order to motivate them towards dietary behavior change and decrease loneliness. The application consists of five different modules, each one applying different behavior change techniques. |
| Measure | Description | Time Frame |
|---|---|---|
| Logdata on use application | Amount of time spend on the application during the 8 weeks intervention period | 8 weeks |
| Change in De Jong Gierveld Loneliness Scale | Score from 1-5, higher score means a better outcome. | Four weeks before intervention to eight weeks |
| Change in eating behaviour based on 24 hours recall | Four weeks before intervention to eight weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Enjoyment via affect scale | Pleasure in using the application. Score from 1-5, higher score means a better outcome. | Eight weeks after intervention |
| Classic aesthetics Scale | The design of the application. Score from 1-7, higher score means a better outcome. |
| Measure | Description | Time Frame |
|---|---|---|
| Willingness to pay single questions | Willing to pay for PACO (y/n) | Eight weeks after intervention |
| User experience via self-formulated open question | Four and eight weeks after intervention |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emely de Vet, PhD | Wageningen University & Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wageningen University & Research | Wageningen | Gelderland | 6706 KN | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35404255 | Derived | 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. | |
| 33404513 | Derived |
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In accordance with the Data Management Plan, part of the data will be anonymized and made available in DANS-EASY with restricted access.
The data will become available within 12 months after the end of the study.
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| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| ID | Term |
|---|---|
| D001522 | Behavior, Animal |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D014850 | Waiting Lists |
| ID | Term |
|---|---|
| D001071 | Appointments and Schedules |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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| UNKNOWN |
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.
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| Waiting list + PACO | Behavioral | Waiting list + PACO |
|
| Eight weeks after intervention |
| Concern for privacy scale | Concerns about sharing personal data, e.g.name and date of birth. Score from 1-7, higher score means a better outcome. | Four and eight weeks after intervention |
| Active control scale | Control over the system, as perceived by the user. Score from 1-7, higher score means a better outcome. | Eight weeks after intervention |
| System Usability Scale | Whether PACO is easy to use. Score from 1-5, higher score means a better outcome. | Eight weeks after intervention |
| Perceived usefulness scale | Score from 1-5, higher score means a better outcome. | Eight weeks after intervention |
| Rapport scale | Relationship with the embodied conversational agent. Score from 1-5, higher score means a better outcome. | Four weeks before intervention to eight weeks |
| Brief Older People's Quality of Life Scake | Score from 1-5, higher score means a better outcome. | Four weeks before intervention to eight weeks |
| Change in Basic Psychological Need Satisfaction and Frustration Scales | Score from 1-5, higher score means a better outcome. | Four weeks before intervention to eight weeks |
| 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. |