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Eine Intervention des virtuellen Lebensgeschichtenclubs zur Verbesserung der Einsamkeit und Apathie bei älteren Erwachsenen in der Gemeinde in der Gemeinde zu verbessern (LSC Feasible)

22. September 2026 aktualisiert von: Montefiore Medical Center

Eine Intervention des virtuellen Lebensgeschichtenclubs zur Verbesserung der Einsamkeit und Apathie bei älteren Erwachsenen in der Gemeinde: Eine Machbarkeitsstudie mit gemischten Methoden

Reminiscence therapy is a non-invasive, non-pharmacological intervention that has been shown to improve cognition, mood, functional status, quality of life, and apathy in older adults. Group reminiscence therapy combines structured social engagement and recounting of personal stories that address both social connection (a risk factor for cognitive decline) and cognition. Life story club© (LSC) is an established, non-profit organization that provides virtual, group reminiscence therapy for older adults to reduce loneliness and promote a sense of belonging and has not been formally studied.

Studienübersicht

Status

Rekrutierung

Intervention / Behandlung

Detaillierte Beschreibung

The purpose of this study is to explore the feasibility of a LSC© intervention to improve loneliness and apathy in community-dwelling older adults.

This pilot study will be conducted to compare loneliness and apathy in lonely individuals without dementia at baseline who receive a virtual group reminiscence therapy intervention (vGRT). The intervention will be delivered weekly over 12 weeks. Loneliness and apathy will be assessed before and after the intervention as described in the Outcome Measures section of this registration. Feasibility will be assessed using quantitative and qualitative measures including feasibility of screening and enrollment, acceptability, and program satisfaction. Qualitative interviews will be conducted with a subset of 30 individuals to explore acceptability, barriers, and facilitators of the intervention.

This study will provide evidence for the feasibility of a virtual group reminiscence therapy for community dwelling older adults to reduce loneliness and apathy. This approach is both innovative and pragmatic because it will leverage an existing community-based service, with an established infrastructure and track record within the community to deliver the intervention. As such, the proposed research has the potential for broad implications for community-based research and aligns with multiple translational science principles.

Studientyp

Interventionell

Einschreibung (Geschätzt)

50

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

    • New York
      • The Bronx, New York, Vereinigte Staaten, 10467
        • Rekrutierung
        • Montefiore Medical Center
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

60 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Age 60 and over
  • English or Spanish fluency
  • Able to provide informed consent

Exclusion Criteria:

  • Dementia based on Aging and Dementia (AD8) score of ≥4 or previous dementia diagnosis
  • Severe auditory or visual loss
  • Lack of access to internet connection or phone

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Life Story Club

Virtual Group Reminiscence Therapy

Virtual group reminiscence therapy will be provided by the Life Story Club©. Participants will meet virtually via Zoom© with their group (6-10 people) weekly for one hour over a 12-week period to exchange life stories and share in conversation. Groups will be conducted in entirely in English or Spanish, based on participant preference. Each week, the LSC© facilitator will guide the group with question prompts to encourage participants to share personal information, build friendships & rapport, and create a sense of community. LSC© facilitators are trained in group interview techniques, technology management, and know how to respond appropriately to sensitive information that may emerge during group exchanges.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Loneliness
Zeitfenster: From baseline to 3 months and 6 months

Loneliness will be assessed using the University of California, Los Angeles (UCLA) Loneliness Scale questionnaire. The UCLA Loneliness Scale is a 20-item measure that assesses how often a person feels disconnected from others. Participants provide responses using a 4-point Likert scale where 1 = never; 2 = rarely; 3 = sometimes; 4 = always, for an overall possible scoring range of 20-80, such that higher scores are associated with increased loneliness. Positively worded items in the questionnaire must be reverse-coded before reporting. For purposes of this study changes from baseline to 3 months and baseline to 6 months will be assessed whereby positive values are indicative of an increase in loneliness from baseline and negative values a decrease in loneliness from baseline. Group scores will be summarized using basic descriptive statistics.

From baseline to 3 months and 6 months
Change in Apathy
Zeitfenster: From baseline to 3 months and 6 months

Apathy will be assessed using the self-reported Apathy Evaluation Scale (AES-S). The AES-S is an 18-item questionnaire that addresses characteristics of goal directed behavior that reflects apathy including behavioral, cognitive, and emotional indicators. Participants provide responses based on a 4-point Likert scale where 1 = not at all true; 2 = slightly true; 3 = somewhat true; and 4 = very true, for an overall possible scoring range of 18-72, such that higher scores are associated with greater apathy. Positively worded items in the scale must be reverse-coded before reporting. For purposes of this study changes from baseline to 3 months and baseline to 6 months will be assessed whereby positive values are indicative of increased apathy from baseline and negative values decreased apathy from baseline. Group scores will be summarized using basic descriptive statistics.

From baseline to 3 months and 6 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in cognition
Zeitfenster: From baseline to 3 months and 6 months

Cognition will be assessed using a version of the Telephone-Montreal Cognitive Assessment (T-MoCA). The T-MoCA is a 22-item phone-administered exam which assesses a range of global cognitive domains including attention, memory, language, and orientation. Each item is one point yielding an overall possible scoring range of 0-22, with higher scores being indicative of better cognitive function. Scores of 18 or below are generally suggestive of Mild Cognitive Impairment (MCI). For purposes of this study changes from baseline to 3 months and baseline to 6 months will be assessed whereby positive values are indicative of increased cognition from baseline and negative values decreased cognition from baseline. Group scores will be summarized using basic descriptive statistics. To reduce practice effect Version (V)8.1 will be administered at baseline, V8.2 at 3 months, and V8.3 at 6 months. Scoring ranges are identical for all 3 versions.

From baseline to 3 months and 6 months
Change in Meaning and Purpose
Zeitfenster: From baseline to 3 months and 6 months

Meaning and purpose will be assessed as a composite measure using the Patient-Reported Outcomes Measurement Information System (PROMIS) Meaning and Purpose 4-item scale. The 4-item scale is designed to assess an individual's subjective experience of meaning and purpose in life. Participants provide responses on a 5-point Likert scale ranging from 1-5 for an overall possible scoring range of 4-20, such that higher scores are associated with greater meaning and purpose. For purposes of this study changes from baseline to 3 months and baseline to 6 months will be assessed whereby positive values are indicative of increased experiences of meaning and purpose from baseline and negative values decreased experiences of meaning and purpose from baseline. Group results will be summarized using basic descriptive statistics

From baseline to 3 months and 6 months
Change in Depressive Symptoms
Zeitfenster: From baseline to 3 months and 6 months

Depressive symptoms will be assessed by administration of the Geriatric Depression Scale - Short Form (GDS-15), The GDS-15 is a 15-item questionnaire in which participants provide a dichotomous (Yes/No) response as to how they have felt over the prior week. Answers suggestive of depression are bolded/italicized on the questionnaire (may either be 'Yes' or 'No' depending on the item). A score of 1 point is assigned for each bolded/italicized response such that higher scores are associated with more depressive symptoms. A score of 0 to 5 is normal. A score greater than 5 suggests depression. For purposes of this study changes from baseline to 3 months and baseline to 6 months will be assessed whereby positive values are indicative of increase in depressive symptoms from baseline and negative values a decrease in depressive symptoms from baseline. Results will be summarized using basic descriptive statistics.

From baseline to 3 months and 6 months
Change in Social Support
Zeitfenster: From baseline to 3 months and 6 months

Social Support will be assessed using the Medical Outcomes Study (MOS) Social Support Scale. The MOS is a 19-item multidimensional, self-administered instrument that measures the availability of support, if needed. The overall social support component of the MOS Social Support scale will be used. Participants provide responses on a 5-point Likert scale ranging from 1-5 for an overall possible scoring range of 19-95, such that higher scores are associated with greater availability of social support. For purposes of this study changes from baseline to 3 months and baseline to 6 months will be assessed whereby positive values are indicative of increased social support and purpose from baseline and negative values decreased social support from baseline. Group results will be summarized using basic descriptive statistics

From baseline to 3 months and 6 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Mirnova Ceide, MD, Montefiore Medical Center

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

15. August 2025

Primärer Abschluss (Geschätzt)

31. Dezember 2027

Studienabschluss (Geschätzt)

31. Dezember 2027

Studienanmeldedaten

Zuerst eingereicht

26. März 2025

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

2. April 2025

Zuerst gepostet (Tatsächlich)

9. April 2025

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

25. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

22. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • 2025-16787
  • UM1TR004400 (US NIH Stipendium/Vertrag)
  • 2025 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

UNENTSCHIEDEN

Beschreibung des IPD-Plans

Data sharing to be determined.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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