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

10 juni 2026 bijgewerkt door: 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)

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

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

Studietype

Ingrijpend

Inschrijving (Geschat)

50

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Spanje
    • Valencia
      • Valencia, Valencia, Spanje, 46010
        • University of Valencia

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Onderzoek naar gezondheidsdiensten
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: 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.
Geen tussenkomst: No intervention group
This group will receive the ussual care in the day centers for familiar caregiver

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Score on the Jong Gierveld Lonelinss Scale
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Score in Goldberg Anxiety and Depression Scale.
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Valencia

Medewerkers

The Faculty of Nursing and Podiatry, University of Valencia.

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 oktober 2026

Primaire voltooiing (Geschat)

1 december 2026

Studie voltooiing (Geschat)

1 december 2028

Studieregistratiedata

Eerst ingediend

4 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

4 juni 2026

Eerst geplaatst (Werkelijk)

10 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

15 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

10 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2024-ENFPOD-3741812

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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