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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04510883
Other study ID # 40-44300-98-110
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 13, 2020
Est. completion date December 30, 2020

Study information

Verified date April 2021
Source Wageningen University and Research
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date December 30, 2020
Est. primary completion date December 30, 2020
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
PACO
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.
Waiting list + PACO
Waiting list + PACO

Locations

Country Name City State
Netherlands Wageningen University & Research Wageningen Gelderland

Sponsors (5)

Lead Sponsor Collaborator
Wageningen University and Research National Foundation for the Elderly, Roessingh Research and Development, WAAG, ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Other Willingness to pay single questions Willing to pay for PACO (y/n) Eight weeks after intervention
Other User experience via self-formulated open question Four and eight weeks after intervention
Primary Logdata on use application Amount of time spend on the application during the 8 weeks intervention period 8 weeks
Primary Change in De Jong Gierveld Loneliness Scale Score from 1-5, higher score means a better outcome. Four weeks before intervention to eight weeks
Primary Change in eating behaviour based on 24 hours recall Four weeks before intervention to eight weeks
Secondary Enjoyment via affect scale Pleasure in using the application. Score from 1-5, higher score means a better outcome. Eight weeks after intervention
Secondary Classic aesthetics Scale The design of the application. Score from 1-7, higher score means a better outcome. Eight weeks after intervention
Secondary 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
Secondary 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
Secondary System Usability Scale Whether PACO is easy to use. Score from 1-5, higher score means a better outcome. Eight weeks after intervention
Secondary Perceived usefulness scale Score from 1-5, higher score means a better outcome. Eight weeks after intervention
Secondary 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
Secondary 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
Secondary 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
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