Clinical trial NCT02356757: Preventing Amputations by Tailored Risk-based Intervention to Optimize Therapy
Official title: Preventing Amputations by Tailored Risk-based Intervention to Optimize Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Foot Ulcer
Keywords: self-care
self-monitoring
medication adherence
diet
physical activity
primary prevention
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2015-02-05
Enrollment: 406
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Ulcerative and non-ulcerative Foot lesions
timeFrame: 12 months
Secondary outcomes:
measure: Foot care skills
timeFrame: 12 months
measure: Foot-care education
timeFrame: 12 months
measure: Medication adherence
timeFrame: 12 months
measure: Diet
timeFrame: 12 months
measure: Physical activity
timeFrame: 12 months
measure: A1c
timeFrame: 12 months
measure: Systolic blood pressure
timeFrame: 12 months
measure: LDL
timeFrame: 12 months
measure: Health-related quality of life
timeFrame: 12 months
measure: Cost-effectiveness
timeFrame: 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
state: New York
Study officials:
affiliation: Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
name: Sundar Natarajan, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: