Clinical trial NCT05891925: An Audiobook-based Intervention on Community-dwelling Older Adults
Official title: An Audiobook-based Intervention on Community-dwelling Older Adults in Concepción, Chile
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychological Well-Being
Mental Health
Keywords: older adults
well-being
audiobook
self-care
healthy aging
eHealth
Lead sponsor: Universidad Católica de la Santísima Concepción
Sponsor class: OTHER
Collaborators: name: Universidad de Concepcion
First posted: 2023-06-07
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study will be conducted over 30 older adults who will use an audiobook mobile application for 4 weeks. Participants will be evaluated pre and post intervention through validated questionnaires on digital competences, usability, and perception of well-being.
Primary purpose: TREATMENT

Brief summary: The goal of this quasiexperimental study is to assess the impact of an audiobook mobile application on the well-being perception of older adults belonging to a Community Rehabilitation Center (CRC) at Concepcion, Chile. The main question is does listening to audio poems using a mobile application improve the perception of well-being of the older adults who go to the CRC at Concepcion? Participants will evaluate the usability of the mobile application designed for this population. The duration of the study will be 4 weeks.

Detailed description: The worldwide population over 60 years of age is increasing. Thus, older adults should maintain interest and participate in social and family activities to help preserve their independence and promote their well-being. Wellbeing is a part of human health in its most general sense which manifests itself in all areas of human activity. Leisure activities such as listening to an audiobook may provide enjoyment and promote relaxation in older people and help improve the well-being of older adults.

A quasiexperimental study to assess the impact of an audiobook mobile application on the well-being perception of older adults and the usability of this application will be conducted during the fourth quarter of 2023. In this study, participants will be compared with themselves at the beginning and at the end of the intervention, that is, a pretest/posttest with a single group.

The first stage corresponds to recruiting community-dwelling older adults, to be done at a community center. With the older adults who agree to participate in the study, the researchers will do the second stage (screening), which consists of determining who can participate in the study by applying the inclusion and exclusion criteria (third stage). Before starting the intervention, participating older adults must accept and sign a written consent (fourth stage). Then, a baseline (fifth stage) will be established by applying standardized and validated tests to the participating older adults, who will then have an induction session to install the application on their smartphones, learn how to use the application and get answers to any questions the participants might have (sixth stage). In the intervention (seventh stage), the participants will use the application for four weeks, with a follow-up at 2 weeks (eighth stage). After these four weeks of application use, the older adults will be evaluated through standardized tests (ninth stage).

The participants will be recruited from the Community Rehabilitation Center (CRC) at Concepcion, Chile. A sample of 60 older adults participated in a similar study to ours. Thus, a non-probabilistic type of sampling will be used for the convenience of the study. In particular, a minimum of 30 participants and a maximum of 60 will be considered to allow obtaining data from the different quintiles and genders within the sample.

Recruitment flyers will be posted on the walls of the CRC to make an open call to all people over 60 being treated at that place. Furthermore, group meetings scheduled by the researchers will be held at the CRC offices to invite older adults to participate in the research. Older adults interested in the study will register by giving their name and telephone number, and will be contacted later by the researchers.

Older adults interested in participating in the study will be contacted by telephone. Then, the study, the objectives of the research and the strategy to be used in the study will be explained to them in a concise and precise way. Furthermore, the researchers will find out if the participants meet the inclusion criteria for the study.

If the older adults refuse to participate, the older adults will be thanked and told there is no harm to them. Otherwise, the older adults will be invited to a meeting at the CRC, on a schedule to be agreed.

During the meeting, the written informed consent will be handed out and explained to them with the support of the consent itself, emphasizing that participation in the study is voluntary, and that the confidentiality of the each participant's personal information will be safeguarded. If the older adult agrees to the consent, it will be signed by them and by the researcher responsible for the research, and the participant will receive a signed copy of the consent.

Then, two questionnaires will be applied to the older adults: one to measure their digital skills (DIGCOMP), and another to assess their well-being prior to the experience with the audiobook application (Part A). This last questionnaire was built by the authors specifically for this application. It consists of two parts, and both the content and face validity were made through by an expert committee, with clinical experience, knowledge in methodological investigation, and disciplinary knowledge in psychology.

Finally, one of the researchers will explain to the older adults how the application works, and answer any questions the participants may have. After the explanation, the audiobook application will be installed on the older adult's smartphone, and the older adult will be provided with a contact telephone number to answer any questions about the operation of the application.

The intervention will consist of the use of the audiobook application for 4 weeks. During this period, the application will record the following data autonomously: older adult id, date, hour and time that the older adult listened to each poem, poems listened. This data will be stored locally and sent to a server for remote storage when the older adult has internet access.

Considering the hypothesis, there is no minimum application frequency of use to be suggested to participants. Thus, older adults should use the audiobook application according to their time availability and their motivation. Furthermore, participants are advised to abstain from any other emotional, social and/or motor training during the intervention period.

After two weeks of application use, a follow-up will be carried out, in order to answer any questions that may arise from the use of the application, and explain again the objectives of the research, if necessary. This follow-up will be initially done by telephone, and in person if required. After four weeks, the older adult will be invited to a meeting at the CRC, on a schedule to be agreed beforehand, to answer the well-being questionnaire (Part B) and the usability questionnaire (SUS). Finally, data analysis will be carried out once the data gathering is finished.

A positive impact on the perception of well-being is expected in older adults who listen to poems through an audiobook mobile application.

Eligibility criteria: Inclusion Criteria:

* Person aged 60 and over who belongs to the Community Rehabilitation Center at Concepción, Chile.
* Speak and read Spanish.
* Enabled and capable of approving the informed consent.
* Provide signed informed consent.
* Older adults who have a smartphone where they can run the audiobook mobile application.
* Older adults who are not participating in other emotional, social and/or motor training programs.

Exclusion Criteria:

* Significant psychiatric or medical illness (depressive disorder, delirium, intellectual disability, etc).
* Older adults classified with dependency criteria.
* Illiterate people.
* Presence of a severe sensory deficit, either in visual or hearing difficulties.
* Presence of neurodegenerative diseases (dementia, Alzheimer's disease, Parkinson's disease, multiple sclerosis, etc.).

Primary outcomes:
measure: Well-being perception pre-intervention
timeFrame: Pre intervention (just before the start of the intervention)
measure: Well-being perception post-intervention
timeFrame: Four weeks after the start of the intervention
measure: Usability of the Audiobook App
timeFrame: Four weeks after the start of the intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Universidad de Concepcion
name: Valeria Espejo-Videla, Msc
role: STUDY_DIRECTOR
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