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Psychological Well-BeingNCT05891925

An Audiobook-based Intervention on Community-dwelling Older Adults

A study testing Audiobook App in people with Psychological Well-Being and Mental Health, run by Universidad Católica de la Santísima Concepción.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Psychological Well-Being, Mental Health
What is being tested?
Audiobook App
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
Oct 2023to Apr 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.).

Trial locations and contacts

No sites are listed yet.

Pedro O. Rossel, PhD contact

+56412345322

prossel@ucsc.cl

Laura Aravena-Canese, Msc contact

+56412204792

laravena@udec.cl

About this study

Official title: 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.

Read the 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.

Being tested
Audiobook App
Keywords
older adults, well-being, audiobook, self-care, healthy aging, eHealth
Medical subject headings
Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Audiobook AppOther

    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).

Study groups in NCT05891925
Study groupRoleWhat they receive
older_adults_CRCExperimentalOver 30 healthy community-dwelling older adults belonging to a Community Rehabilitation Center (CRC) at Concepcion, Chile.
Receives: Other: Audiobook App

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Well-being perception pre-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.

    Measured: Pre intervention (just before the start of the intervention)

  2. Well-being perception post-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.

    Measured: Four weeks after the start of the intervention

  3. Usability of the Audiobook App

    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.

    Measured: Four weeks after the start of the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2023
  2. Study startOct 2023 (estimated)
  3. Primary completionJan 2024 (estimated)
  4. Study completionApr 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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.
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05891925
Sponsor's protocol ID
UCSantísimaConcepción
Status last verified
May 2023
First submitted
12 May 2023
Last updated
7 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ki-moon B. Follow-up to the Second World Assembly on Ageing. General Assembly of the United Nations, 2011

  • Wick G, Jansen-Durr P, Berger P, Blasko I, Grubeck-Loebenstein B. Diseases of aging. Vaccine. 2000 Feb 25;18(16):1567-83. doi: 10.1016/s0264-410x(99)00489-2.

    PubMed 10689131
  • Huenchuan-Navarro S. Diferencias Sociales en la Vejez. Aproximaciones Conceptuales y Teóricas. Revista Perspectivas 2003; 12: 13-22.

  • Villafuerte RJ, Alonso AYA, Alonso VY, et al. Elderly well-being and quality of life, a challenge for inter-sectoral action. Medisur. 2017;15(1):85-62.

  • Forsblom, A., Särkämö, T., Laitinen, S., & Tervaniemi, M. The effect of music and audiobook listening on people recovering from stroke: The patient's point of view. Music and Medicine. 2010; 2(4), 229-234.

  • Bauger L, Bongaardt R. Structural developmental psychology and health promotion in the third age. Health Promot Int. 2018 Aug 1;33(4):686-694. doi: 10.1093/heapro/daw104.

    PubMed 28082372
  • Chang Dae Lee, Moon Young Kim, Mi Jung Lee, Jaewon Kang & Erin R. Foster. The relationship between active, balanced participation and well-being in older adults in the United States: A time-use perspective. Journal of Occupational Science. 2023; 30:2, 175-183.

  • Araújo, Lia, Ribeiro, Oscar, & Paúl, Constança. Hedonic and eudaimonic well-being in old age through positive psychology studies: a scoping review. Anales de Psicología. 2017; 33(3), 568-577.

  • Ryan RM, Deci EL. On happiness and human potentials: a review of research on hedonic and eudaimonic well-being. Annu Rev Psychol. 2001;52:141-66. doi: 10.1146/annurev.psych.52.1.141.

    PubMed 11148302
  • Keyes, C. L. M. Social well-being. Social Psychology Quarterly. 1998; 61(2), 121-140.

  • Stav WB, Hallenen T, Lane J, Arbesman M. Systematic review of occupational engagement and health outcomes among community-dwelling older adults. Am J Occup Ther. 2012 May-Jun;66(3):301-10. doi: 10.5014/ajot.2012.003707.

    PubMed 22549595
  • Bauger L, Bongaardt R. The lived experience of well-being in retirement: A phenomenological study. Int J Qual Stud Health Well-being. 2016 Nov 3;11:33110. doi: 10.3402/qhw.v11.33110. eCollection 2016.

    PubMed 27814778
  • Kim J, Lee HY, Christensen MC, Merighi JR. Technology Access and Use, and Their Associations With Social Engagement Among Older Adults: Do Women and Men Differ? J Gerontol B Psychol Sci Soc Sci. 2017 Sep 1;72(5):836-845. doi: 10.1093/geronb/gbw123.

    PubMed 28073816
  • Fang Y, Chau AKC, Wong A, Fung HH, Woo J. Information and communicative technology use enhances psychological well-being of older adults: the roles of age, social connectedness, and frailty status. Aging Ment Health. 2018 Nov;22(11):1516-1524. doi: 10.1080/13607863.2017.1358354. Epub 2017 Aug 4.

    PubMed 28777010
  • Cota T and Ishitani L. Motivation and benefits of digital games for the elderly: a systematic literature review. Revista Brasileira de Computação Aplicada. 2015; 7(1): 2-16.

Questions about this trial

What is this clinical trial studying?

A study testing Audiobook App in people with Psychological Well-Being and Mental Health, run by Universidad Católica de la Santísima Concepción.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Pedro O. Rossel, PhD (+56412345322, prossel@ucsc.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Well-being perception pre-intervention (time frame: Pre intervention (just before the start of the intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05891925, which also lists 28 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.

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