- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02356757
Preventing Amputations by Tailored Risk-based Intervention to Optimize Therapy (PATRIOT)
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Amputation is a devastating complication of diabetes that is preceded in > 80% of cases by foot ulcers. Veterans with diabetes are at risk for incident foot ulcers, particularly if they have neuropathy, vascular disease or anatomic abnormalities. This risk is worsened if they have poor foot self-care, poor foot self-monitoring and/or poor control of A1c and other risk factors. It is important to activate at-risk Veterans to improve self-care and self-monitoring, and lower other amputation risks.
The PATRIOT study is a randomized controlled trial (RCT) testing the effectiveness of a personalized behavioral intervention (PBI) aimed to improve foot self-care, foot self-monitoring, and modifiable risks for amputation such as A1c, BP, LDL and smoking using behavioral counseling combined with dermal thermometry. The primary specific aim is to evaluate the effect of PBI on the proportion of foot lesions (ulcerative or non-ulcerative) compared to current best practice (CBP) care for diabetes. The secondary specific aims are to evaluate the impact of PBI on foot self-care skills, foot education and adherence, A1c, BP and LDL, and quality of life at 6 months as well as its longer-term effects at 12 months; and cost-effectiveness compared to CBP. The will also examine the effect of PBI and CBP on demonstrated foot self-care, plantar pressures, inflammation, satisfaction and intervention acceptability.
The investigators will randomize 404 adults with diabetes who are at higher than normal risk of foot ulcers [Risk score of 1, 2 or 3 (with no history of ulcers or amputations)] to the PBI and CBP equally. The PBI is a cohesive, personalized intervention targeting foot self-care and self-monitoring that includes dermal thermometry, diet, exercise, and medication-taking incorporating self-regulatory theory, the Transtheoretical Model and Prospect Theory and delivered using Motivational Interviewing principles and the teach back method. The interventions will be standardized and fidelity of the intervention will be maintained. Through a blinded RCT, the investigators will test the effect of PBI in relation to CBP. Key outcomes are non-ulcerative and ulcerative lesions, foot-care skills, foot care education, adherence to diet and medication, general and foot health-specific quality of life, A1c, BP, and LDL. Outcomes will be measured at baseline, 6 and 12 months. All analyses will be intent-to-treat.
This study will evaluate a cohesive risk-stratified personalized behavioral intervention aimed to improve self-care, enhance self-monitoring and reduce incident ulcers in adults without a previous diabetic foot ulcer. This study applies established behavioral theories combined with new technology to intervene and improve care for adults with diabetes who are at risk for amputation. If this promising theory-driven primary prevention approach to prevent foot lesions can work in a clinical setting where improvements in foot care are urgently needed, it will be an important scientific contribution that could lower the risk of amputation in adults with diabetes.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
New York
-
New York, New York, Forente stater, 10010
- Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Adults with diabetes and PAVE score 1, 2 or 3, drug therapy for > 6 months
- An available phone
- At least 2 primary care visits in the previous 1.5 years at the recruitment site
Exclusion Criteria:
- Patients with acute CVD events < 3 months ago
- 86 poor estimated short-term survival (< 1 year)
- Recent major surgery (< 3 months)
- Inability to exercise
- Prior toe or foot amputation
- Prior foot ulcer
- Temporary residence in the area
- Inability to provide consent will be excluded
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Personalized Behavioral Intervention (PBI)
The PBI is a 12-month long integrated, multicomponent counseling and dermal thermometry intervention targeting foot self-care, foot self-monitoring, diet, medication and physical activity.
The intervention is based on self-regulation theory, the Transtheoretical Model and
|
The PBI is based on self-regulation theory, the Transtheoretical Model and Prospect Theory, and will be delivered using Motivational Interviewing principles and the teach-back method.
Participants will receive monthly calls targeting foot self-care, foot self-monitoring, diet, medication and physical activity for 6 months.
Call/mailing frequency during the next 6 months will depend on adherence level to foot self-care and self-monitoring at 6 months.
Andre navn:
|
Placebo komparator: Current Best Practice (CBP)
This group will receive all the enhancements that the VA has targeted to improve foot risk in diabetes and foot care, and will also receive counseling regarding preventing general health conditions.
|
CBP will include monthly calls from a counselor focusing on preventing conditions like colorectal cancer, flu, insomnia, vision problems, memory loss and oral disease for the first 6 months.
Frequency of calls and mailings from counselors during the next 6 months will be determined by level of adherence to preventive strategies during the first 6 months.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Ulcerative and non-ulcerative Foot lesions
Tidsramme: 12 months
|
High-resolution standard view digital photographs of the feet and footwear will be obtained and reviewed by the investigators blinded to group assignment, and a suspected ulcer or nonulcerative plantar lesion below the malleoli will be referred to a blinded (as to group assignment) adjudicators, all clinical experts.
Lesions will be judged as absent/nonulcerative lesion/ulcer
|
12 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Foot care skills
Tidsramme: 12 months
|
The investigators will use the Veterans foot self-care education and behavior survey to assess foot care.
|
12 months
|
Foot-care education
Tidsramme: 12 months
|
The investigators will use the Veterans foot self-care education and behavior survey to assess basic foot-care education and extended foot-care education.
This survey was developed and validated in high-risk Veterans.
|
12 months
|
Medication adherence
Tidsramme: 12 months
|
This will be assessed primarily by refill frequency using the pharmacy database , supplemented by the self-reported medication-taking scale.
Refill compliance is an objective measurement of medication adherence that utilizes pharmacy records to assess the proportion of time a patient has medication available.
|
12 months
|
Diet
Tidsramme: 12 months
|
Diet will be assessed by food frequency questionnaire
|
12 months
|
Physical activity
Tidsramme: 12 months
|
Physical activity will be assessed via accelerometer.
|
12 months
|
A1c
Tidsramme: 12 months
|
Fasting blood will be processed for A1c.
|
12 months
|
Systolic blood pressure
Tidsramme: 12 months
|
Blood pressure will be measured with an Omron automated machine and the mean of 6 BP's over 2 hours.
used.
|
12 months
|
LDL
Tidsramme: 12 months
|
Fasting blood will be processed for LDL cholesterol.
|
12 months
|
Health-related quality of life
Tidsramme: 12 months
|
General health-related quality of life will be assessed using the Veterans SF-12.
The investigators will also measure foot health-specific quality of life.
Measures are reliable and valid.
|
12 months
|
Cost-effectiveness
Tidsramme: 12 months
|
The investigators will measure direct medical costs (costs of drugs, tests, supplies, personnel, and facilities),direct non-medical costs (transportation), and indirect (patient's time and caregiver's time).
The investigators will also calculate quality-adjusted life years using the ED-5D survey to adjust for health states.
|
12 months
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Sundar Natarajan, MD MSc, Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
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
- IIR 14-009
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
produkt produsert i og eksportert fra USA
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Personalized Behavioral Intervention
-
VA Office of Research and DevelopmentFullført
-
VA Office of Research and DevelopmentRekruttering
-
VA Office of Research and DevelopmentMichael E. DeBakey VA Medical Center; Dallas VA Medical CenterRekrutteringDepresjon | Muskel- og skjelettsmerter | Aldring | Kroniske ryggsmerterForente stater
-
Spaulding Rehabilitation HospitalEunice Kennedy Shriver National Institute of Child Health and Human Development... og andre samarbeidspartnereHar ikke rekruttert ennåSlag | Hjerneslag følgetilstander | Hemiparese; Postslag/CVAForente stater
-
The University of Texas Health Science Center,...Eunice Kennedy Shriver National Institute of Child Health and Human Development...RekrutteringKandidat for fedmekirurgi | Overvekt, ungdomForente stater
-
UConn HealthNational Heart, Lung, and Blood Institute (NHLBI)Fullført
-
Queen's UniversityCanadian Institutes of Health Research (CIHR)Fullført
-
Baylor College of MedicineRekruttering
-
University of WashingtonNational Institute on Alcohol Abuse and Alcoholism (NIAAA)FullførtAlkoholdrikking | Problem med å drikkeForente stater
-
IDeA States Pediatric Clinical Trials NetworkNational Institutes of Health (NIH)Fullført