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ElderTree Smart System per anziani

24 settembre 2026 aggiornato da: University of Wisconsin, Madison

Utilizzo di dispositivi intelligenti per implementare un sistema di sanità elettronica basato sull'evidenza per gli anziani

Multiple chronic conditions (MCCs) are costly and pervasive among older adults. MCCs account for 90% of Medicare spending, and 65% of Medicare beneficiaries have 3 or more chronic conditions; 23% have 5 or more. MCCs are often addressed in primary care, where time pressures force a focus on medication and lab results rather than self-management skills.

The primary purpose of this study is to investigate whether voice-activated "smart" technology increases adoption and sustains use of an evidence-based electronic health intervention (Elder Tree, or ET) for older adults with multiple chronic conditions, and thereby improves its potential to widely enhance quality of life and health outcomes. ET is an existing intervention providing tools, motivation, and support on a computer platform to help older adults manage their health.

An Agency for Health Care Research and Quality (AHRQ)-funded randomized controlled trial (RCT) found that ET improved quality of life and other factors among high users of primary care with multiple chronic conditions such as diabetes and hypertension. However, many people did not use it extensively, which is a common problem with all web apps.

Panoramica dello studio

Tipo di studio

Interventistico

Iscrizione (Effettivo)

268

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.

Luoghi di studio

    • Wisconsin
      • Madison, Wisconsin, Stati Uniti, 53704
        • University of Wisconsin School of Medicine and Public Health

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

60 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Be ≥60 years old;
  • Have been treated in University of Wisconsin (UW) Health clinics, with no plans to leave during the study period (only relevant for UW Health patients, not patients recruited from the community);
  • Have a chronic pain diagnosis AND a medical diagnoses of three or more of the following common chronic conditions: Chronic obstructive pulmonary disease (COPD), asthma, diabetes, hyperlipidemia, hypertension, ischemic heart disease, atrial fibrillation, heart failure, stroke, BMI 30+, cancer, chronic kidney disease, depression, osteoporosis, arthritis, or dizziness/falls/loss of vestibular function;
  • Be willing to share healthcare use (e.g. 30-day readmissions) in electronic health records (only relevant for UW Health patients, not patients recruited from the community); and
  • Allow researchers to share information about a patient's health status with their primary care physician (PCP).

Exclusion Criteria:

  • Require an interpreter

  • Have a medical diagnosis of any of the following:

    • Alzheimer's
    • Schizophrenia/other psychotic disorders
    • Dementia
    • Autism spectrum disorder
    • Known terminal illness with less than 6 months to live
    • Acute medical problem requiring immediate hospitalization

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: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Control group

Participants will receive treatment as usual (TAU).

Treatment as usual (TAU)

Sperimentale: ElderTree on laptop (ET- LT)

Participants will receive ElderTree on a laptop.

ElderTree (ET) is an existing intervention providing tools, motivation, and support on a computer platform to help older adults manage their health.

ET is based on the extensively tested Comprehensive Health Enhancement Support System (CHESS). ET is a "walled garden" free of ads, with design features based on older users' feedback as well as best-practice principles such as uncluttered screens and large type. ET uses computers to deliver key elements of successful interventions: long duration, ongoing outreach, prompts, monitoring, cognitive reframing, action planning, problem solving, self-tailoring, and peer support. ET-LT arm will access ET on Laptop (ET- LT)

Sperimentale: ElderTree on smart system (ET- SS)

Participants will receive ElderTree on a smart system.

ElderTree (ET) is an existing intervention providing tools, motivation, and support on a computer platform to help older adults manage their health.

ET is based on the extensively tested Comprehensive Health Enhancement Support System (CHESS). ET is a "walled garden" free of ads, with design features based on older users' feedback as well as best-practice principles such as uncluttered screens and large type. ET uses computers to deliver key elements of successful interventions: long duration, ongoing outreach, prompts, monitoring, cognitive reframing, action planning, problem solving, self-tailoring, and peer support.

ElderTree on smart system (ET- SS) will use voice-activated "smart" speakers connected to the Internet. Because they are used by talking and listening rather than typing and reading, many barriers associated with laptop use can be avoided.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v2.1 - Pain Interference Score
Lasso di tempo: Baseline, 4 months, 8 months

Pain interference was measured using the 4-item subscale from the PROMIS 29. The items asked participants to answer regarding the past 7 days. Scoring of individual items varies and is calculated by the scale's developers; with higher values indicating more pain interference. The possible range is 41.1 to 76.3 (PROMIS scores reported here have weighted ranges).

Baseline, 4 months, 8 months
Change in PROMIS Short Form v2.1 - Psychosocial Quality of Life Score
Lasso di tempo: Baseline, 4 months, 8 months

Psychosocial quality of life was measured using the 12-item subscale from the PROMIS 29. The items asked participants to answer regarding the past 7 days. Scoring of individual items varies and is calculated by the scale's developers; with higher values indicating better quality of life. The possible range is 21.2 to 67.6.

Baseline, 4 months, 8 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
ElderTree Days of Use
Lasso di tempo: baseline to 4 months, and 4 months to 8 months

Days of ElderTree use within a 4 month period before their survey date. The possible range for days of ElderTree use is 0 to 120.

baseline to 4 months, and 4 months to 8 months
Physical Quality of Life
Lasso di tempo: Baseline, 4 months, 8 months

Physical quality of life was measured using the 12-item subscale from the PROMIS 29 (Patient-Reported Outcomes Measurement Information System) Global Health. The items asked participants to answer regarding the past 7 days. Scoring of individual items varies and is calculated by the scale's developers; with higher values indicating more physical quality of life. The possible range is 16.2-67.7.

Baseline, 4 months, 8 months
Pain Intensity
Lasso di tempo: Baseline, 4 months, 8 months

Pain intensity was measured using a single item subscale from the PROMIS 29 (Patient-Reported Outcomes Measurement Information System) Global Health. The item asked participants to answer regarding the past 7 days. The raw score of the item was used (range: 0-10); with higher values indicating more pain intensity.

Baseline, 4 months, 8 months
Number of Participants Readmitted Within 30-days
Lasso di tempo: Baseline, 4 months, 8 months

30-day readmissions were measured using a single item asking participants to answer regarding the past 4 months. The raw score, answering yes/no to having a 30-day readmission, was used. Those participants answering 'yes' to being readmitted in the last 30 days are reported for each time point.

Baseline, 4 months, 8 months
Health Distress
Lasso di tempo: Baseline, 4 months, 8 months

Health distress was measured using the 4-item Lorig Health Distress Scale. The items asked participants to answer regarding the past month. The measure was scored by averaged the items; with higher values indicating more health distress. Possible range is 0 to 5.

Baseline, 4 months, 8 months
Well-being
Lasso di tempo: Baseline, 4 months, 8 months

Well-being was measured using the 5-items World Health Organization (WHO) Well-Being Index. The items asked participants to answer regarding the past 7 days. The measure was scored by summing the items; with higher values indicating better well-being. Possible range is 0 to 25.

Baseline, 4 months, 8 months
Loneliness
Lasso di tempo: Baseline, 4 months, 8 months

Loneliness was measured using the 5-item NIH Toolbox Social Relationship Scale Loneliness. The items asked participants to answer regarding the past month. Scoring of individual items varies and is calculated by the scale's developers; with higher values indicating more Loneliness. Possible range is 20 to 80.

Baseline, 4 months, 8 months
Irritability
Lasso di tempo: Baseline, 4 months, 8 months

Irritability was measured using the 5-item Brief Irritability Test. The items asked participants to answer regarding the past 7 days. The measure was scored by summing the items; with higher values indicating more irritability. Possible range is 5 to 30.

Baseline, 4 months, 8 months
Communication With Physicians
Lasso di tempo: Baseline, 4 months, 8 months

Communication with physicians was measured using the 3-item Lorig Communication with Physicians. The items asked participants to answer regarding the past 4 months. The measure was scored by averaging the items; with higher values indicating better communication with the healthcare provider. Possible range is 0 to 5.

Baseline, 4 months, 8 months

Collaboratori e investigatori

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

Investigatori

  • Investigatore principale: David H. Gustafson, PhD, UW-Madison

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.

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 (Effettivo)

29 luglio 2021

Completamento primario (Effettivo)

26 settembre 2023

Completamento dello studio (Effettivo)

26 settembre 2023

Date di iscrizione allo studio

Primo inviato

11 marzo 2021

Primo inviato che soddisfa i criteri di controllo qualità

11 marzo 2021

Primo Inserito (Effettivo)

15 marzo 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

28 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 settembre 2026

Ultimo verificato

1 ottobre 2024

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 2020-0868
  • ENGR/INDUSTRIAL ENGR (Altro identificatore: UW Madison)
  • A195000 (Altro identificatore: UW Madison)
  • Protocol Version 10/20/2021 (Altro identificatore: UW Madison)
  • 1R18HS026853-01A1 (Sovvenzione/contratto AHRQ degli Stati Uniti)

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 .

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