- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02356757
Preventing Amputations by Tailored Risk-based Intervention to Optimize Therapy (PATRIOT)
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
New York
-
New York, New York, Stati Uniti, 10010
- Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: 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.
Altri nomi:
|
Comparatore placebo: 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.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Ulcerative and non-ulcerative Foot lesions
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Foot care skills
Lasso di tempo: 12 months
|
The investigators will use the Veterans foot self-care education and behavior survey to assess foot care.
|
12 months
|
Foot-care education
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 12 months
|
Diet will be assessed by food frequency questionnaire
|
12 months
|
Physical activity
Lasso di tempo: 12 months
|
Physical activity will be assessed via accelerometer.
|
12 months
|
A1c
Lasso di tempo: 12 months
|
Fasting blood will be processed for A1c.
|
12 months
|
Systolic blood pressure
Lasso di tempo: 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
Lasso di tempo: 12 months
|
Fasting blood will be processed for LDL cholesterol.
|
12 months
|
Health-related quality of life
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Sundar Natarajan, MD MSc, Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- IIR 14-009
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
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 .
Prove cliniche su Personalized Behavioral Intervention
-
University of PittsburghReclutamentoDistrofia muscolare di DuchenneStati Uniti
-
Sarah MorrowLawson Health Research InstituteCompletato
-
Rutgers, The State University of New JerseyAutism SpeaksReclutamentoAggressione | Comportamento problema | Ferita autoinflittaStati Uniti
-
Network for Engineering and Economics Research...CompletatoContraccezione | Anemia da carenza di ferro della gravidanza | Cura prenatale | Assistenza postnataleIndia
-
Assuta Hospital SystemsTel Aviv UniversityCompletato
-
Weill Medical College of Cornell UniversityReclutamentoDepressione perinatale | Ansia perinataleStati Uniti
-
University of TulsaTerminatoSuicidio, tentatoStati Uniti
-
Lisbon Institute of Global Mental Health - LIGMHColumbia UniversityReclutamentoDisturbi psicotici | Schizofrenia | Disordine bipolare | Disturbo affettivo schizoidePortogallo
-
Indiana UniversityUniversity of South Florida; National Institute on Minority Health and Health... e altri collaboratoriCompletatoIntervento DECIDE modificato | Trattamento come consueto gruppo di curaStati Uniti
-
Florida International UniversityNon ancora reclutamentoSindrome da deficit di attenzione e iperattivitàStati Uniti