Preventing Amputations by Tailored Risk-based Intervention to Optimize Therapy

NCT02356757 | Completed

• 1 other identifier: IIR 14-009
• Study Type: interventional
• Target: 406
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Foot Ulcer

Keywords

self-care; self-monitoring; medication adherence; diet; physical activity; primary prevention

Outcome Measures

Primary Outcomes (1)

• Ulcerative and non-ulcerative Foot lesions

  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

Secondary Outcomes (10)

• Foot care skills

  12 months

• Foot-care education

  12 months

• Medication adherence

  12 months

• Diet

  12 months

• Physical activity

  12 months

Study Arms (2)

Personalized Behavioral Intervention (PBI)

EXPERIMENTAL

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

Behavioral: Personalized Behavioral Intervention

Current Best Practice (CBP)

PLACEBO COMPARATOR

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.

Behavioral: Current Best Practice

Interventions

Personalized Behavioral Intervention BEHAVIORAL

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.

Also known as: PBI

Personalized Behavioral Intervention (PBI)

Current Best Practice BEHAVIORAL

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.

Also known as: CBP

Current Best Practice (CBP)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with acute CVD events \< 3 months ago
• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

New York, New York, 10010, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Foot Ulcer; Medication Adherence; Motor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Leg Ulcer; Skin Ulcer; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Sundar Natarajan, MD MSc

  Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2015
• First Posted: February 5, 2015
• Study Start: August 24, 2015
• Primary Completion: June 30, 2021
• Study Completion: September 30, 2021
• Last Updated: October 22, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)