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OpenTrials
Completed

NCT Number: NCT04510883

Usage and Health Effects of Embodied Conversational Agents Among Older Adults

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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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wageningen University & Research

Wageningen, Gelderland, 6706 KN, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Waiting list + PACO

Behavioral

Waiting list + PACO

Primary outcomes

  1. Logdata on use application

    Time frame: 8 weeks

    Amount of time spend on the application during the 8 weeks intervention period

  2. Change in De Jong Gierveld Loneliness Scale

    Time frame: Four weeks before intervention to eight weeks

    Score from 1-5, higher score means a better outcome.

  3. Change in eating behaviour based on 24 hours recall

    Time frame: Four weeks before intervention to eight weeks

Secondary outcomes

  1. Enjoyment via affect scale

    Time frame: Eight weeks after intervention

    Pleasure in using the application. Score from 1-5, higher score means a better outcome.

  2. Classic aesthetics Scale

    Time frame: Eight weeks after intervention

    The design of the application. Score from 1-7, higher score means a better outcome.

  3. Concern for privacy scale

    Time frame: Four and eight weeks after intervention

    Concerns about sharing personal data, e.g.name and date of birth. Score from 1-7, higher score means a better outcome.

  4. Active control scale

    Time frame: Eight weeks after intervention

    Control over the system, as perceived by the user. Score from 1-7, higher score means a better outcome.

  5. System Usability Scale

    Time frame: Eight weeks after intervention

    Whether PACO is easy to use. Score from 1-5, higher score means a better outcome.

  6. Perceived usefulness scale

    Time frame: Eight weeks after intervention

    Score from 1-5, higher score means a better outcome.

  7. Rapport scale

    Time frame: Four weeks before intervention to eight weeks

    Relationship with the embodied conversational agent. Score from 1-5, higher score means a better outcome.

  8. Brief Older People's Quality of Life Scake

    Time frame: Four weeks before intervention to eight weeks

    Score from 1-5, higher score means a better outcome.

  9. Change in Basic Psychological Need Satisfaction and Frustration Scales

    Time frame: Four weeks before intervention to eight weeks

    Score from 1-5, higher score means a better outcome.

Other outcomes

  1. Willingness to pay single questions

    Time frame: Eight weeks after intervention

    Willing to pay for PACO (y/n)

  2. User experience via self-formulated open question

    Time frame: Four and eight weeks after intervention

Sponsors and collaborators

Lead sponsor

Wageningen University and Research

Other

Collaborators

  • National Foundation for the Elderly
  • Roessingh Research and Development
  • WAAG
  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 12, 2020
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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