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ElderTree Smart-systeem voor oudere volwassenen

24 september 2026 bijgewerkt door: University of Wisconsin, Madison

Slimme apparaten gebruiken om een ​​op bewijzen gebaseerd e-gezondheidssysteem voor ouderen te implementeren

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.

Studie Overzicht

Studietype

Ingrijpend

Inschrijving (Werkelijk)

268

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.

Studie Locaties

    • Wisconsin
      • Madison, Wisconsin, Verenigde Staten, 53704
        • University of Wisconsin School of Medicine and Public Health

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

60 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

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: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Placebo-vergelijker: Control group

Participants will receive treatment as usual (TAU).

Treatment as usual (TAU)

Experimenteel: 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)

Experimenteel: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v2.1 - Pain Interference Score
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
ElderTree Days of Use
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

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

Onderzoekers

  • Hoofdonderzoeker: David H. Gustafson, PhD, UW-Madison

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.

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 (Werkelijk)

29 juli 2021

Primaire voltooiing (Werkelijk)

26 september 2023

Studie voltooiing (Werkelijk)

26 september 2023

Studieregistratiedata

Eerst ingediend

11 maart 2021

Eerst ingediend dat voldeed aan de QC-criteria

11 maart 2021

Eerst geplaatst (Werkelijk)

15 maart 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 september 2026

Laatste update ingediend die voldeed aan QC-criteria

24 september 2026

Laatst geverifieerd

1 oktober 2024

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • 2020-0868
  • ENGR/INDUSTRIAL ENGR (Andere identificatie: UW Madison)
  • A195000 (Andere identificatie: UW Madison)
  • Protocol Version 10/20/2021 (Andere identificatie: UW Madison)
  • 1R18HS026853-01A1 (Amerikaanse AHRQ-subsidie/contract)

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

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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