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Active, not recruitingNCT06569628Updated Aug 26, 2024

Validation of a Life Stories Methodologies in Long-Term Care Centres

An interventional study of Envita Stories Methodology in Long-term care Centres for old adults and Contact Methodology in Long-term Care Centres for old adults in Long-term Care Centres for Old Adults Users, Relatives of Long-term Care Centres for Old Adults Users and Long-term Care Centres for Old Adults Professionals, sponsored by Envita Digital Solutions S.L.. Active, not recruiting at 2 sites in Spain. Per ClinicalTrials.gov, last updated 2024-08-26.

Sponsored by Envita Digital Solutions S.L. · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Apr 2024, registered Jul 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
378
Allocation
Non-randomized
Sex
All
01

Study summary

The objective of the research is to validate a methodology for implementing narrative care, through the incorporation of people's biographies and life stories, in interventions in long-term care centres for older adults.

From a positivist perspective of gerontological intervention, priority will be given to the validation of quantitative methodologies with empirical support. The study will involve 378 users residing in Galician long-term care centres for older adults. At the theoretical level, there is a broad consensus among professionals and experts on the need to develop new methodologies that allow the personalization of long-term care care and facilitate the development and promotion of the life projects of the older persons through the provision of the support that a particular person needs. In addition, there is a large body of practical interventions that attempt to apply these postulates. However, there is a clear lack of research methodologies that provide robust scientific results and data to support and evaluate these new developments.

Read the detailed description

A. Background

Narrative care and the methodology of incorporating biographies and life stories emerged in the context of long-term care centres for old-adults in response to the need to promote the deinstitutionalization of care and to advance in the transformation of the long-term care model towards a humanistic approach, and from the ethical and intervention proposal of person-centered care.

Putting this care approach into practice can be complex. In general, the traditional care model and seeing gerontological centers as "institutions" does not favor the implementation of person-centered care methodologies. Society, in general, and professionals in particular are faced with the challenge of promoting the search for solutions to care from a more human point of view in which the so-called "narrative care" takes center stage.

In this context, the need emerges to provide care professionals with new digital tools that facilitate the implementation of valuable methodologies such as life stories, the life project, the professional of reference and the support group, and develop proposals focused on favoring spaces for the creation and strengthening of bonds and meaningful relationships that promote the participation and social inclusion of the person in his/her environment and community, as a protective factor against unwanted loneliness in people in need of long-term care.

Furthermore, at the theoretical level, there is a broad consensus among professionals and experts on the need to develop new methodologies that allow the personalization of long-term care and facilitate the development and promotion of the life projects of the older persons through the provision of the support that a particular person needs. In addition, there is a large body of practical interventions that attempt to apply these postulates. However, there is a clear lack of research methodologies that provide robust scientific results and data to support and evaluate these new developments.

B. Problem or need to which it is intended to provide an answer.

This project jointly addresses the binomial long-term care-unwanted loneliness in long-term care centres for old-adults, betting on digitization as a key element in the search for solutions. The purpose is to advance the line of research in three main areas:

  1. Narrative care and person-centered care

    Person-centered care (PCC) proposes a paradigm shift in long-term care, placing people in need of care/support and their life projects at the center of organizations, at the backbone of their processes.

    The life stories and the life project are advanced methodologies typical of person-centered care approaches that facilitate old-adults, in this case, are the axis around which the interventions and the day-to-day communications of the centers revolve.

    The professionals who care for and/or accompany people have to understand life stories method as the essence of person-centered care and humanization. The experts argue that it is an inexcusable component of genuine person-centered care, a component that acquires meaning not only by virtue of its effectiveness and the practical benefits it implies, but also as an ethical imperative of care. It is a valuable tool that allows us to know and recognize the person, to respect and understand him or her better.

  2. Unwanted loneliness

    According to data from the survey on loneliness in older people conducted by La Caixa Foundation in 2018 in Spain, there is a higher prevalence of loneliness in institutionalized old adults than in the general population, with this prevalence being much higher.

    Another noteworthy fact is the high prevalence of institutionalized old adults who indicate that their life is not satisfactory and/or they do not feel that they have a meaningful life.

    In turn, most old adults feel unwanted loneliness throughout their lives, regardless of their living situation.

    The experts point out that the main interventions to alleviate loneliness are aimed at: 1) direct interventions with the person, fostering social connections and helping to maintain those that already exist; 2) interventions in the environment, focused on developing appropriate structural facilitators in a close environment to help reduce loneliness and prevent it in people at risk of experiencing it.

  3. Digitalization

This project will offer an essential digital solution that guides, facilitates and supports the implementation of life stories and life project methodologies, through which it intervenes in 3 key concepts: 1) Care (personalized attention); 2) Involvement (meaningful activities, promotion of the life project); 3) Unwanted loneliness (creating spaces for valuable interactions and meaningful relationships), from the approach of good practice in the incorporation of technology in the field of care (Liedo and Ausín, 2022).

C. Objectives

The general objective is to empirically support the implementation methodology of narrative care by incorporating biographies and life stories in the context of long-term care with old adults, professionals and families, validating the effects of the program in centres.

The proposal would have two main specific objectives:

  1. To review the empirical evidence on digital applications in PCC concepts.

    1.1. Care (personalization, personalized care) (Incorporation of biography into care).

    1.2. Involvement (Meaningful activities) (Promoting life project)

    1.3. Unwanted loneliness (relationships, bonds, community) (Create spaces for valuable interactions and meaningful relationships).

  2. To validate the effects of the application of narrative care through the incorporation of life stories and biographies, in long-term care centres for old adults, by means of a randomized clinical trial.

2.1. To validate the cognitive effects of the application in long-term care centres for old adults.

2.2. To validate the functional impact of the application in long-term care centres for old adults, through the facilitation of participation in daily life and in their community and the promotion of new illusions, goals or dreams to be fulfilled.

2.3. To validate the effects at the affective level of the application in long-term care centres for old adults, through the promotion of emotional connection and the promotion of meaningful relationships.

2.4. To validate the effects on social support of the application in long-term care centres for old adults, through the activation of meaningful relationships, the strengthening of bonds and relationships of trust, encouraging family participation in care and improving communication patterns.

2.5. To assess the perception of professionals on the use of the resources deployed through the intervention methodology.

02

Conditions studied

  • Long-term Care Centres for Old Adults Users
  • Relatives of Long-term Care Centres for Old Adults Users
  • Long-term Care Centres for Old Adults Professionals

Keywords

  • Life Review
  • Life Story
  • Narrative Care
  • Digitalization
  • Envita Stories
  • Person-centred Care
  • Long-term Care Centres
  • Long-term Care
03

In context

Lead sponsor

This is the only study on the registry with Envita Digital Solutions S.L. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion criteria: Old adults living in a long-term care centre in Galicia (Spain).

Exclusion criteria: N/A

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Factorial assignment
Masking
Single (Participant)
Enrollment
378 participants (estimated)

Study arms

  • Experimental
    Intervention group in Long-term Care Centres for old adults

    This group participates directly in the incorporation of narrative care through the implementation of life stories and biographies (Envita Stories Methodology) in the long-term care centres for old adults in where they reside, through the specific workshops and by preparing their own life stories

    Combination Product: Envita Stories Methodology in Long-term care Centres for old adults

  • Active comparator
    Contact group in long-term care Centres for old adults

    This group participates indirectly, through the implementation of the Envita Stories Methodology in the long-term care centres for old adults in which they reside but not in them directly

    Behavioral: Contact Methodology in Long-term Care Centres for old adults

  • No intervention
    Control group in Long-term care centres for old adults

    This Group resides in a long-term care centres for old adults in which the methodology is not being implemented, although it will be implemented throughout the project process

Interventions

  • Combination productEnvita Stories Methodology in Long-term care Centres for old adults

    Collaborative intervention program in long-term care Centres for old adults between professionals, old adults, families and volunteers that aims to foster person-centered care and promote meaningful relationships through the digitization of life stories and life project methodologies in a timeline.

  • BehavioralContact Methodology in Long-term Care Centres for old adults

    Professionals know and use Envita Stories Methodology but do not apply it directly with these people.

06

What researchers measure

Primary outcomes

  1. Cognitive status

    Montreal cognitive assessment (MoCA). The Montreal Cognitive Assessment (MoCA) is designed to assess mild cognitive dysfunction. This instrument examines the following skills: attention, concentration, executive functions (including the capacity for abstraction), memory, language, visuoconstructive abilities, calculation and orientation.

    Time frame: Three assessments: (1) Baseline assesment: Month 1, (2) 1st follow-up assessment: between month 7 and month 10; and (3) 2nd follow-up assessment: between month 13 and month 16.

  2. Memory

    Test of Memory Impairment (T@M). The Test of Memory Impairment (T@M) is a cognitive screening test, with a high discriminatory value for amnestic mild cognitive impairment and mild Alzheimer's disease among the general population. It consists of five sections: Immediate Memory, Temporal Orientation Memory, Semantic Remote Memory, Free Recall Memory and Cue Recall Memory

    Time frame: Three assessments: (1) Baseline assesment: Month 1, (2) 1st follow-up assessment: between month 7 and month 10; and (3) 2nd follow-up assessment: between month 13 and month 16.

  3. Functional Status

    Lawton and Brody Instrumental Activities of Daily Living Scale. It evaluates the daily functionality of the person by means of 8 items: ability to use the telephone, shopping, food preparation, housekeeping, laundry, use of means of transportation and responsibility regarding medication and administration of their finances.

    Time frame: Three assessments: (1) Baseline assesment: Month 1, (2) 1st follow-up assessment: between month 7 and month 10; and (3) 2nd follow-up assessment: between month 13 and month 16.

  4. Affectivity and Emotions

    PANAS questionnaire of positive and negative moods. This questionnaire allows to evaluate, separately, the positive (10 questions) and negative (10 questions) emotional experiences recently lived.

    Time frame: Three assessments: (1) Baseline assesment: Month 1, (2) 1st follow-up assessment: between month 7 and month 10; and (3) 2nd follow-up assessment: between month 13 and month 16.

  5. Social network

    OARS Social Resources Scale. It assesses the social network of the old adults.

    Time frame: Three assessments: (1) Baseline assesment: Month 1, (2) 1st follow-up assessment: between month 7 and month 10; and (3) 2nd follow-up assessment: between month 13 and month 16.

  6. Loneliness

    DeJong Loneliness Questionnaire. Assesses emotional loneliness, missing an intimate relationship, and social loneliness, missing a wider social network.

    Time frame: Three assessments: (1) Baseline assesment: Month 1, (2) 1st follow-up assessment: between month 7 and month 10; and (3) 2nd follow-up assessment: between month 13 and month 16.

  7. Acceptance of Technology

    d-hoc user experience questionnaire based on the Technology Acceptance Model (Nieto-Vietes et al., 2023)

    Time frame: Three assessments: (1) Baseline assesment: Month 1, (2) 1st follow-up assessment: between month 7 and month 10; and (3) 2nd follow-up assessment: between month 13 and month 16.

07

Study locations

2 sites
  • Faculty of Psychology of the University of Santiago de Compostela
    Santiago De Compostela, Galicia 15782, Spain
  • Envita Digital Solutions S.L.
    Vigo, Pontevedra/Galicia 36211, Spain
08

References and documents

Publications

  • Villar F, Serrat R. [Talk to them: Narrative care within a person-centered care framework]. Rev Esp Geriatr Gerontol. 2017 Jul-Aug;52(4):216-222. doi: 10.1016/j.regg.2016.06.004. Epub 2016 Jul 25. Spanish. PubMed 27461990 ↗
  • Kitwood T, Bredin K. Towards a theory of dementia care: personhood and well-being. Ageing Soc. 1992;12:269-87. doi: 10.1017/s0144686x0000502x. No abstract available. PubMed 11654434 ↗
  • Costa NP, Polaro SH, Vahl EA, Goncalves LH. Storytelling: a care technology in continuing education for active ageing. Rev Bras Enferm. 2016 Nov-Dec;69(6):1132-1139. doi: 10.1590/0034-7167-2016-0390. English, Portuguese. PubMed 27925090 ↗
  • Stargatt J, Bhar S, Bhowmik J, Al Mahmud A. Digital Storytelling for Health-Related Outcomes in Older Adults: Systematic Review. J Med Internet Res. 2022 Jan 12;24(1):e28113. doi: 10.2196/28113. PubMed 35019845 ↗
  • Subramaniam P, Woods B. Digital life storybooks for people with dementia living in care homes: an evaluation. Clin Interv Aging. 2016 Sep 16;11:1263-1276. doi: 10.2147/CIA.S111097. eCollection 2016. PubMed 27698556 ↗
  • Gately ME, Muccini S, Eggleston BA, McLaren JE. Program Evaluation of My Life, My Story: Virtual Storytelling in the COVID-19 Age. Clin Gerontol. 2022 Jan-Feb;45(1):195-203. doi: 10.1080/07317115.2021.1931610. Epub 2021 Jul 5. PubMed 34219605 ↗
  • Rios Rincon AM, Miguel Cruz A, Daum C, Neubauer N, Comeau A, Liu L. Digital Storytelling in Older Adults With Typical Aging, and With Mild Cognitive Impairment or Dementia: A Systematic Literature Review. J Appl Gerontol. 2022 Mar;41(3):867-880. doi: 10.1177/07334648211015456. Epub 2021 May 19. PubMed 34009053 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06569628
Lead sponsor
Envita Digital Solutions S.L.
Collaborators
Agencia Gallega de Innovación (GAIN), Faculty of Psychology, University of Santiago de Compostela, Santiago de Compostela, Galicia-Spain, DomusVi, long-term care centres for old adults
Responsible party
Sponsor
First posted
Aug 26, 2024
Start date
Apr 25, 2024
Primary completion
Oct 2026 (estimated)
Completion
Apr 2027 (estimated)
Last update
Aug 26, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is active, not recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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