Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Intervention to Reduce Unwanted Loneliness in Family Caregivers of People With Alzheimer

4 giugno 2026 aggiornato da: Silvia Corchón Arreche, University of Valencia

Multimodal Intervention to Reduce Unwanted Loneliness and Improve the Living With Process Among Family Caregivers of People With Alzheimer's Disease

The absence of social relationships negatively affects physical, psychological, and social health. In other words, it alters people's quality of life and makes active aging difficult. The investigators have designed a study to reduce unwanted loneliness and improve the living with process of family caregivers of people with Alzheimer disease through multiple interventions (music therapy, health education)

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This project proposes a multimodal and interdisciplinary intervention aimed at alleviating or reducing unwanted loneliness and improving the living with process of family caregivers of individuals with Alzheimer's disease (AD). In doing so, it seeks to enhance their health and overall quality of life. The intervention will include activities such as health education, physical activity and music therapy.

The interdisciplinary team will also incorporate citizen participation, specifically through the involvement of an individual who has previously been a family caregiver of a person with AD. There is a growing body of evidence indicating that citizen participation in healthcare is highly advisable, as it is expected to improve the quality and relevance of outcomes (Kirby et al., 2024).

This is a prospective, longitudinal, analytical, and experimental study.

The proposed study will involve different groups and the program will last for a total of 12 weeks. The program will include the following activities:

Physical exercise adapted to the physical conditions of each participant. Total of 12 sessions.

Health education workshops. A total of 12 workshops. These will include group training talks on the following topics: sleep hygiene, diet, and cognitive stimulation, Alzheimer disease, among others.

Music therapy workshops. Through listening to songs, singing, dancing, guided relaxation with music, and group instrumental performance, the enjoyment and expression of feelings will be encouraged. There will be 1 session per week. Total 12 sessions

Tipo di studio

Interventistico

Iscrizione (Stimato)

50

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Spagna
    • Valencia
      • Valencia, Valencia, Spagna, 46010
        • University of Valencia

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Family caregivers of people with Alzheimer's disease (AD).
  • Primary family caregivers who live with the person with AD.
  • The person with AD must be enrolled in one of the adult day care centers where the study is conducted.
  • Ability to communicate in Spanish and/or Valencian.

Exclusion Criteria:

  • Presence of moderate or severe cognitive impairment, mental disorder, significant sensory impairment, disabling chronic illness, or any medical condition that contraindicates participation in any of the study activities.
  • Family caregivers of institutionalized individuals.
  • Family caregivers of people with AD who have died.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Experimental group

The multimodal interventions includes:

  1. Behavioral: Health education for family caregivers of patients with Alzheimer disease with unwanted loneliness Twelve health education workshops will be carried out. These include group training talks on the following topics: sleep hygiene, diet, and cognitive stimulation, among others.
  2. Behavioral: Music therapy for community-dwelling individuals with unwanted loneliness Description: Music therapy workshops will implemented. The enjoyment and expression of feelings will encouraged by listening to songs, singing, dancing, guided relaxation with music, and group instrumental performance. One session per week. Total 12 sessions
  3. Behavioral: Physical exercise adapted to the physical conditions of each participant. Total of 12 sessions.
Comportamentale: Multimodal intervention to Reduce Unwanted Loneliness in Family Caregivers of People With Alzheimer

The multimodal intervention will include these activities:

  1. Health education workshops
  2. Music therapy sessions
  3. Physical exercise adapted to the physical conditions of each participant.
Nessun intervento: No intervention group
This group will receive the ussual care in the day centers for familiar caregiver

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Score on the Jong Gierveld Lonelinss Scale
Lasso di tempo: From the beginning of the enrollement until the end of the intervention at 12 weeks

Loneliness Scale Social isolation will be measured with the Jong Gierveld Loneliness Scale.

The final score is the total score for the 11 items, with the lowest possible score being 0 (no loneliness) and the highest being 11 (severe loneliness). Three categories have been proposed based on the score: a score of 0-2 points = no loneliness; a score of 3-8 points = moderate loneliness; and a score of 9-11 points = severe loneliness.
From the beginning of the enrollement until the end of the intervention at 12 weeks
Living with chronic conditions from the family perspective
Lasso di tempo: From the enrollment to the end of the intervention at 12 weeks
Living with LTCs scale from the perspective of the family caregiver (EC- PC- Fam). This is an instrument adapted from the original EC- PC.29-31 The adaptation process of the instrument and prior pilot study have been previously described in detail.23 The validated version has 31 items and 5 domains: (1) acceptance, (2) coping, (3) self- management, (4) integration and (5) adaptation. All the items follow a Likert scale of 5 points answer system, from never or none (0) to always and much (4), except for the items from the acceptance domain, which must be inverted to obtain results such as never or none (4) or always or much (0). The scores range from 0 to 155, with a higher score indicating more positive living with LTCs.
From the enrollment to the end of the intervention at 12 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Score in Goldberg Anxiety and Depression Scale.
Lasso di tempo: From enrollement until the end of the intervention ar 12 weeks

The symptoms of anxiety and depression will be measured with the Goldberg Anxiety and Depression Scale.

This is a questionnaire that discriminates between the diagnosis of anxiety and depression and measures their retrospective intensities. It consists of two subscales: one for anxiety and one for depression. Each subscale is composed of 9 dichotomous response items (YES or NO) to determine whether the subject has had any of the indicated symptoms in the last two weeks. The cut-off points are 4 or more items or affirmative responses for the anxiety scale and 2 or more for the depression scale. The higher the score, the greater the severity of the problem, with a maximum possible score of 9 points for each subscale.
From enrollement until the end of the intervention ar 12 weeks
The score in the EuroQQL-5
Lasso di tempo: From enrollement until the end of the intervention at 12 weeks
The EuroQOL- 5 Dimensions 5- Level version (EQ- 5D- 5L) is an instrument designed to generically measure HRQOL, which can be used by both a healthy population and an individual with pathologies. The instrument developed by the EUROQOL group32 has been validated in many countries, including Spain.33 34 Different versions can be found, and in the present study, the EQ- 5D- 5L was selected due to the increase in the specificity of the responses as compared with the EQ- 5D- 3L. It is a self- administered instrument in which individuals assess their own health, first in a descriptive manner for each of the dimensions (mobility, personal care, everyday activities, pain/ discomfort and anxiety/depression), with five levels, from 0 to 5, and then with a more general Visual Analogical Scale. For the Spanish context, the psycho metric properties of the EQ- 5D- 5L scale were analysed in patients35 with the results indicating a reliability of 0.86.
From enrollement until the end of the intervention at 12 weeks
Score in Zarit Test for caregiver burden
Lasso di tempo: From enrollement until the end of the intervention at 12 weeks
Zarit test: This scale is included to verify the external validity (divergent validity) of the EC- PC- Fam. This scale, originally named Caregiver Burden Interview, is designed to assess the burden of caregivers of indi viduals with dementia, from the general theory of the items39. It has 22 items that evaluate the negative repercussions on specific areas of daily life associated with caregiving: physical health, psychological health, social activities and economic resources. As opposed to the original, the version validated in Spain40 includes a 5- point Likert scale, for a total score that ranges from 22 to 110. In this study, different cut- off points were proposed: from 22 to 46, without burden; from 47 to 55, with burden and from 56 to 110, intense burden. The scale obtained an internal consistency of 0.91 and test-retest reliability of 0.96.
From enrollement until the end of the intervention at 12 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Valencia

Collaboratori

The Faculty of Nursing and Podiatry, University of Valencia.

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 ottobre 2026

Completamento primario (Stimato)

1 dicembre 2026

Completamento dello studio (Stimato)

1 dicembre 2028

Date di iscrizione allo studio

Primo inviato

4 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

4 giugno 2026

Primo Inserito (Effettivo)

10 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2024-ENFPOD-3741812

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Caregiver familiari

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Liberia

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi