Utvide treningsprogrammering for veteraner gjennom telehelse
Utvide treningsprogrammering for veteraner gjennom telehelse (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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Lauren Abbate, MD
- Telefonnummer: 3177 (303) 399-8020
- E-post: Lauren.Abbate@va.gov
Studer Kontakt Backup
- Navn: Andrew T Stephens
- Telefonnummer: (720) 723-6726
- E-post: Andrew.Stephens1@va.gov
Studiesteder
-
-
Colorado
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Aurora, Colorado, Forente stater, 80045-7211
- Rekruttering
- Rocky Mountain Regional VA Medical Center, Aurora, CO
-
Ta kontakt med:
- Lauren Abbate, MD
- Telefonnummer: 3177 (303) 399-8020
- E-post: Lauren.Abbate@va.gov
-
Hovedetterforsker:
- Lauren Abbate, MD
-
Ta kontakt med:
- Andrew T Stephens
- Telefonnummer: (720) 723-6726
- E-post: Andrew.Stephens1@va.gov
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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. |
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. |
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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Lauren Abbate, MD, Rocky Mountain Regional VA Medical Center, Aurora, CO
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CDX 22-008
- 5IK2HX003053-03 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
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