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Udvidelse af træningsprogrammering for veteraner gennem telehealth

29. september 2026 opdateret af: VA Office of Research and Development

Udvidelse af træningsprogrammering for veteraner gennem telehealth (CDA 22-066)

The goal of this study is to evaluate the acceptability and feasibility of a group telehealth exercise program for Veterans with lower extremity osteoarthritis (OA). Methods: This is a randomized pilot trial where Veterans (n=50) receive a group telehealth exercise program (3 months), followed by an exercise maintenance phase (6 months) that includes either text messaging alone or text messaging plus group telehealth exercise booster sessions. The primary outcomes for this study are feasibility and acceptability of the intervention. Feasibility will be assessed through number and source of referrals, recruitment, and retention. Acceptability will be assessed through surveys and interviews for participants and providers addressing reasons for participation, satisfaction, perceived appropriateness, and overall experience containing Likert scales and both yes/no and open-ended questions. Exploratory outcomes, assessed at multiple time points during the course of the study, will measure changes in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and changes in performance measure and physical activity assessed remotely through individual telehealth sessions. Data will be collected at baseline, 3-, 6-, and 9-month follow-up.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

50

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045-7211
        • Rekruttering
        • Rocky Mountain Regional VA Medical Center, Aurora, CO
        • Kontakt:
        • Ledende efterforsker:
          • Lauren Abbate, MD
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • diagnosis of symptomatic knee or hip osteoarthritis (OA)
  • Veterans at Eastern Colorado Healthcare System Primary Care Clinics with at least one VA visit within the past year
  • physically inactive (add definition)

Exclusion Criteria:

  • No telephone access
  • hip or knee surgery or acute meniscus or anterior cruciate ligament tear in the past six months
  • recent hospitalization for cardiovascular/cerebrovascular event
  • serious mental health condition or behavioral issues precluding participating in group exercise
  • terminal illness
  • motor neuron diseases
  • severely impaired hearing, vision, or speech
  • non-English speaking
  • current participation in another osteoarthritis (OA) or exercise intervention or lifestyle change study
  • other self-reported or study team/primary care physician deemed health condition that would prohibit participation in the study
  • no primary care physician visit in past 12 months
  • pregnant women
  • insufficient internet connectivity to participate in group telehealth

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Exercise Initiation and Maintenance with Text Messaging and Booster Sessions

Participants receive 3 months of group telehealth exercise initiation plus text messaging followed by 6 months of text messaging plus monthly group telehealth exercise booster sessions.
Adfærdsmæssigt: Group Telehealth Exercise Sessions with text messaging plus booster sessions

Participants receive 3 months of group telehealth exercise initiation plus text messaging followed by 6 months of text messaging plus monthly group telehealth exercise booster sessions.
Aktiv komparator: Exercise Initiation and Maintenance with Text Messaging alone

Participants receive 3 months of group telehealth exercise initiation plus text messaging followed by 6 months of text messaging alone.
Adfærdsmæssigt: Group Telehealth Exercise Sessions with text messaging plus booster sessions

Participants receive 3 months of group telehealth exercise initiation plus text messaging followed by 6 months of text messaging plus monthly group telehealth exercise booster sessions.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Referrals
Tidsramme: 3 months

The number of referrals made by providers, through chart review, and the number of self-referrals by Veterans will be collected as a measure of feasibility.
3 months
Number of sessions attended
Tidsramme: 3 months

The number of sessions attended as a percentage of the number offered will be gathered as a measure of feasibility and acceptability.
3 months
Recruitment
Tidsramme: 3 months

The goal is that 50% of eligible provider and self-referrals and 25% of chart review referrals will participate in the program as a measure of success.
3 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Scores
Tidsramme: Baseline, 3 months, 6 months, and 9 months.

Changes in lower extremity pain (5 items), stiffness (2 items), and function (17 items) assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale scores. Each item is scored on a Likert scale ranging from 0 to 4 (none, mild, moderate, severe, and extreme). Scores range from 0-96 and higher scores are generally associated with worse outcomes.
Baseline, 3 months, 6 months, and 9 months.

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in 30-second chair stand test
Tidsramme: Baseline, 3 months, 9 months

Number of times participant can rise from sitting in a chair in 30 seconds. Higher scores indicate higher function.
Baseline, 3 months, 9 months
Change in 2-minute Step Test
Tidsramme: baseline, 3 months, 9 months

The number of steps in place (right knee to midpoint of upper leg = 1 step) in 2 minutes. Higher scores indicate higher function.
baseline, 3 months, 9 months
Change in Arm Curls
Tidsramme: Baseline, 3 months, 9 months

The number of curls performed in 30 seconds. Higher scores indicate higher function.
Baseline, 3 months, 9 months
Change in Accelerometry Data
Tidsramme: Baseline, 3 months, 6 months, 9 months

Gathered using an ActiGraph worn on wrist for 7 consecutive days. Specifically step changes in step counts. Larger increases indicate increased physical activity.
Baseline, 3 months, 6 months, 9 months
Change in Number of Steps assessed by Pedometer
Tidsramme: Baseline, 3 months, 6 months, 9 months

Daily steps recorded by Veteran in AnnieApp text message reply and in daily exercise logs. Larger increases indicate increased physical activity.
Baseline, 3 months, 6 months, 9 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

VA Office of Research and Development

Efterforskere

  • Ledende efterforsker: Lauren Abbate, MD, Rocky Mountain Regional VA Medical Center, Aurora, CO

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. april 2023

Primær færdiggørelse (Anslået)

31. december 2026

Studieafslutning (Anslået)

31. marts 2027

Datoer for studieregistrering

Først indsendt

17. november 2022

Først indsendt, der opfyldte QC-kriterier

16. december 2022

Først opslået (Faktiske)

27. december 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CDX 22-008
  • 5IK2HX003053-03 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

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