An Audiobook-based Intervention on Community-dwelling Older Adults

May 26, 2023 updated by: Pedro O. Rossel, Universidad Católica de la Santísima Concepción

An Audiobook-based Intervention on Community-dwelling Older Adults in Concepción, Chile

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Pedro O. Rossel, PhD
  • Phone Number: +56412345322
  • Email: prossel@ucsc.cl

Study Contact Backup

  • Name: Laura Aravena-Canese, Msc
  • Phone Number: +56412204792
  • Email: laravena@udec.cl

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: older_adults_CRC
Over 30 healthy community-dwelling older adults belonging to a Community Rehabilitation Center (CRC) at Concepcion, Chile.
Other: Audiobook App

The intervention will consist of the use of the audiobook application (with poems) for 4 weeks. Here, 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.

Initially, 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).

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 Community Rehabilitation Center at Concepción, Chile, to answer the well-being questionnaire (Part B) and the usability questionnaire (SUS).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Well-being perception pre-intervention
Time Frame: Pre intervention (just before the start of the intervention)

"Well-being questionnaire Part A" is related to well-being perception, and this will measure the well-being of the older adults before the use of the audiobook application. This questionnaire was built by the researchers specifically for this application.

Part A includes 6 questions that are assessed with a 5-point Likert subjective scale (1 strongly disagree and 5 strongly agree). This questionnaire measures the following types of well-being: Hedonic, Eudaimonic, and Social.

The score obtained in the questionnaire Part A will be between 6 and 30. This score represents the final well-being obtained for older adults before the use of the application. A higher score mean a better outcome.
Pre intervention (just before the start of the intervention)
Well-being perception post-intervention
Time Frame: Four weeks after the start of the intervention

"Well-being questionnaire Part B" is related to well-being perception, and this will measure the well-being of the older adults after the use of the audiobook application. This questionnaire was built by the researchers specifically for this application

Part B includes 12 questions that are assessed with a 5-point Likert subjective scale (1 strongly disagree and 5 strongly agree). This questionnaire measures the following types of well-being: Hedonic, Eudaimonic, and Social.

The score obtained in the questionnaire Part B will be between 12 and 60. This score represents the final well-being obtained for older adults after the use of the application. A higher score mean a better outcome.
Four weeks after the start of the intervention
Usability of the Audiobook App
Time Frame: Four weeks after the start of the intervention

Usability is a software quality attribute that assesses how easy user interfaces are to use.

To measure the usability of the application, the System Usability Scale (SUS) will be used. It consists of 10 questions that are assessed with a 3-point Likert subjective scale (1 totally disagree and 3 completely agree) and it allows quickly answer. The result is between 0 and 100; the higher the result, the higher the usability level of the application.
Four weeks after the start of the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Católica de la Santísima Concepción

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Universidad de Concepcion

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Valeria Espejo-Videla, Msc, Universidad de Concepcion

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 12, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 7, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UCSantísimaConcepción

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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