DiabetesPATRIOTNCT02356757
Preventing Amputations by Tailored Risk-based Intervention to Optimize Therapy
A study testing Personalized Behavioral Intervention and Current Best Practice in people with Diabetes and Foot Ulcer, run by VA Office of Research and Development at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Diabetes, Foot Ulcer
- What is being tested?
- Personalized Behavioral Intervention and Current Best Practice
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 406 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2015to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
New York, New York, 10010
About this study
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.
Read the 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.
- Conditions
- Diabetes, Foot Ulcer
- Being tested
- Personalized Behavioral Intervention, Current Best Practice
- Keywords
- self-care, self-monitoring, medication adherence, diet, physical activity, primary prevention
- Medical subject headings
- Diabetes Mellitus, Foot Ulcer, Medication Adherence, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Behavioral InterventionBehavioural
Also called PBI
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.
Current Best PracticeBehavioural
Also called CBP
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: Current Best Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (10)
Foot care skills
The investigators will use the Veterans foot self-care education and behavior survey to assess foot care.
Measured: 12 months
Foot-care education
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.
Measured: 12 months
Medication adherence
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.
Measured: 12 months
Diet
Diet will be assessed by food frequency questionnaire
Measured: 12 months
Physical activity
Physical activity will be assessed via accelerometer.
Measured: 12 months
A1c
Fasting blood will be processed for A1c.
Measured: 12 months
Systolic blood pressure
Blood pressure will be measured with an Omron automated machine and the mean of 6 BP's over 2 hours. used.
Measured: 12 months
LDL
Fasting blood will be processed for LDL cholesterol.
Measured: 12 months
Health-related quality of life
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.
Measured: 12 months
Cost-effectiveness
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2015 (estimated)
- Study start24 Aug 2015
- Primary completion30 Jun 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 406 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Sundar Natarajan, MD MSc, Principal investigator, Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02356757
- Sponsor's protocol ID
- IIR 14-009
- Acronym
- PATRIOT
- Status last verified
- Oct 2021
- First submitted
- 2 Feb 2015
- Last updated
- 22 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Amputations by Tailored Risk-based Intervention to Optimize Therapy
- ClinicalTrials.gov ID
- NCT02356757
- Acronym / sponsor ID
- PATRIOT / IIR 14-009
- Conditions
- Diabetes, Foot Ulcer
- Keywords
- self-care, self-monitoring, medication adherence, diet, physical activity, primary prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 406 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 24 Aug 2015 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 5 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized Behavioral Intervention (PBI) | Experimental | Behavioral: Personalized Behavioral InterventionThe 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 |
| Current Best Practice (CBP) | Placebo comparator | Behavioral: Current Best PracticeThis 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized Behavioral InterventionAlso: PBIThe 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. | Behavioural | Personalized Behavioral Intervention (PBI) |
| Current Best PracticeAlso: CBPCBP 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. | Behavioural | Current Best Practice (CBP) |
Primary outcome
Ulcerative and non-ulcerative Foot lesions
Time frame: 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
10 secondary outcomes
Foot care skills
Time frame: 12 months
Foot-care education
Time frame: 12 months
Medication adherence
Time frame: 12 months
Diet
Time frame: 12 months
Physical activity
Time frame: 12 months
A1c
Time frame: 12 months
Systolic blood pressure
Time frame: 12 months
LDL
Time frame: 12 months
Health-related quality of life
Time frame: 12 months
Cost-effectiveness
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sundar Natarajan, MD MSc principal investigator
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Behavioral Intervention and Current Best Practice in people with Diabetes and Foot Ulcer, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ulcerative and non-ulcerative Foot lesions (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2021.