NCT06569628

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
378

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Apr 2024

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Apr 2024Apr 2027

Study Start

First participant enrolled

April 25, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2024

Completed
26 days until next milestone

First Posted

Study publicly available on registry

August 26, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

August 26, 2024

Status Verified

August 1, 2024

Enrollment Period

2.4 years

First QC Date

July 31, 2024

Last Update Submit

August 21, 2024

Conditions

Keywords

Life ReviewLife StoryNarrative CareDigitalizationEnvita StoriesPerson-centred CareLong-term Care CentresLong-term Care

Outcome Measures

Primary Outcomes (7)

  • 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.

    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.

  • 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

    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.

  • 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.

    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.

  • 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.

    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.

  • Social network

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

    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.

  • Loneliness

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

    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.

  • Acceptance of Technology

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

    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.

Study Arms (3)

Intervention group in Long-term Care Centres for old adults

EXPERIMENTAL

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

Contact group in long-term care Centres for old adults

ACTIVE COMPARATOR

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

Control group in Long-term care centres for old adults

NO INTERVENTION

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

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.

Intervention group in Long-term Care Centres for old adults

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

Contact group in long-term care Centres for old adults

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of Psychology of the University of Santiago de Compostela

Santiago de Compostela, Galicia, 15782, Spain

Location

Envita Digital Solutions S.L.

Vigo, Pontevedra/Galicia, 36211, Spain

Location

Related Publications (7)

  • 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.

    PMID: 27461990BACKGROUND
  • 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.

    PMID: 11654434BACKGROUND
  • 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.

    PMID: 27925090BACKGROUND
  • 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.

    PMID: 35019845BACKGROUND
  • 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.

    PMID: 27698556BACKGROUND
  • 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.

    PMID: 34219605BACKGROUND
  • 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.

    PMID: 34009053BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Model Details: Long-term Care Centres for old adults users will be divided into three groups: 1)Intervention group: participates directly in the incorporation of the proposed methodology; 2)Contact group: participates indirectly (implementation of the methodology in the centres in which they reside but not in them directly); 3)Non-contact control group: resides in a centre in which the methodology is not being implemented. This process will also involve the reference professionals involved in the implementation of the methodology and those family members who voluntarily become involved in the care of the participants based on this methodology.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2024

First Posted

August 26, 2024

Study Start

April 25, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

April 1, 2027

Last Updated

August 26, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations