Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02356757 |
| Other study ID # |
IIR 14-009 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 24, 2015 |
| Est. completion date |
September 30, 2021 |
Study information
| Verified date |
October 2021 |
| Source |
VA Office of Research and Development |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The PATRIOT study will evaluate a risk-based personalized behavioral intervention to improve
foot self-care, self-monitoring, and modifiable risks for amputation such as blood glucose,
blood pressure and cholesterol in order to prevent diabetic foot ulcers in patients at higher
than normal risk for amputation. This novel intervention aims to improve self-care and early
detection of foot abnormalities in at-risk patients with diabetes and poor foot self-care
using advanced behavioral approaches to target adherence to multiple health behaviors,
including foot self-care, self-monitoring, medication adherence, dietary adherence, and
physical activity simultaneously. If this promising behavioral theory-driven approach
delivered using common technology (phone) to the patient at home can work in a setting where
improvements in foot care are so urgent, it will be an important scientific contribution.
Description:
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.
