Peripheral Artery DiseaseTeGeCoachNCT03496948
Telephone Health Coaching and Remote Exercise Monitoring for Peripheral Artery Disease
A study testing TeGeCoach in people with Peripheral Artery Disease and Atherosclerosis, run by Universitätsklinikum Hamburg-Eppendorf at 3 sites in Germany.
Trial summary
Peripheral artery disease (PAD) is the third most prevalent cardiovascular disease worldwide, with over 200 million people affected. Most prominent symptom is leg pain while walking known as intermittent claudication. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Peripheral Artery Disease, Atherosclerosis, Peripheral Arterial Disease
- What is being tested?
- TeGeCoach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,982 participants
- Where
- 3 sitesGermany
- Study dates
- 23 Apr 2018to 15 Feb 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Insured with one of the three participating health insurance companies
- Sufficient German language skills to follow the telephone-based health coaching
- Access to a telephone (landline or mobile);
- Primary or secondary diagnosis of PAD at Fontaine stage IIa or IIb within the last 36 months, but no primary or secondary diagnosis of PAD at Fontaine stage I within the last 12 months; or at Fontaine stage III or IV within the last 36 months
- Inpatient and outpatient diagnoses from routine statutory health insurance data will be used to identify eligible patients.
Who cannot join
- Immobility that goes beyond claudication (inability to carry out intervention and competing risks)
- Severe and persistent mental disorders (adherence reasons)
- Suicidality (safety reasons)
- Life-threatening somatic diseases (e.g., cancer; competing risk)
- Active or recent participation in any other PAD intervention trial
- Ongoing hospitalization; alcoholism and other drug dependency (adherence reasons)
- Heart failure graded New York Heart Association (NYHA) class III and IV (inability to carry out intervention and competing risks)
- Ineligible patients are identified based on diagnoses that were made in inpatient settings only, given the considerable number of diagnostic errors in outpatient settings.
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
TK statutory health insurance
Hamburg, 22305
KKH statutory health insurance
Hanover, 30625
Mhplus Statutory Health Insurance
Nuremberg, 90411
About this study
Official title: PAD-TeGeCoach: Health Coaching and Telemetry Supported Walking Exercise for Improving Quality of Life
Peripheral artery disease (PAD) is the third most prevalent cardiovascular disease worldwide, with over 200 million people affected. Most prominent symptom is leg pain while walking known as intermittent claudication. Based on the currently existing gaps in the management of intermittent claudication, the objective of the this study is to explore the clinical effectiveness and cost advantage of TeGeCoach, a 12-month long home-based exercise program, compared to usual care. TeGeCoach consists of telephone health coaching, remote walking exercise monitoring based on wearable activity monitors and intensified primary care. It is hypothesized that TeGeCoach will improve functional outcomes and will reduce total health care costs.
Read the detailed description
Peripheral artery disease (PAD) is the third most prevalent cardiovascular disease worldwide and has become a serious public health issue, with over 200 million people affected. Smoking and diabetes are the strongest risk factors for the development of peripheral artery disease, but also high cholesterol, high blood pressure and sedentary lifestyle. The most prominent symptom is leg pain while walking known as intermittent claudication, as the muscles do not get enough blood during exercise to meet the needs. To improve mobility, first line treatment for intermittent claudication are outpatient supervised exercise programs (SEPs); however, their implementation face manifold challenges: low patient adherence, no reimbursement by insurers, high costs of course implementation, and low course availability. These barriers led to the development of home-based exercise programs, which are similarly effective when combined with a structured approach by setting exercise goals, monitoring exercise activity, and regular follow up with a coach. Therefore, this trial aims to determine the clinical effectiveness and cost advantage of TeGeCoach, a 12-month long structured home-based exercise program (HEP), compared with usual care of intermittent claudication. It is hypothesized that TeGeCoach will improve walking impairment and will lower the need of health care resources that are spent on patients with PAD at 24-month follow-up.
The investigators will conduct a prospective, open-label, pragmatic randomized controlled clinical trial in a health insurance setting. 1760 patients with peripheral artery disease at Fontaine stage II will be randomly assigned either to TeGeCoach or Care-as-usual (usual care). TeGeCoach consists of telemonitored walking exercise using wearable activity trackers, telephone health coaching and medical supervision by a physician. The health coaching is a patient-centered approach based on motivational interviewing, shared decision-making and active listening techniques for supporting better patient engagement and activation, disease self-care, treatment adherence and lifestyle management. Depending on the individual functional status and exercise capacity, participants will be asked to walk up to seven times a week. Usual care participants regularly receive information leaflets and can access supervised exercise programs, physical therapy and a variety of programs for promoting a healthy lifestyle. Primary outcomes are functional capacity measured by the Walking Impairment Questionnaire (WIQ). Secondary outcome measures include quality of life, health literacy and health behavior. Claims data is used to collect total health care costs, healthcare resource use and (severe) adverse events. Outcomes will be measured at three time points (0, 12, and 24 months).
Clearly, the current routine care of intermittent claudication in patients with PAD is partly ineffective und insufficient, with the consequence of a poorly served patient population and worsening disease condition. TeGeCoach may provide an effective and feasible alternative in the management of intermittent claudication by improving access to supervised exercise while at the same time potentially reducing health care costs.
- Conditions
- Peripheral Artery Disease, Atherosclerosis, Peripheral Arterial Disease, Arterial Occlusive Diseases, Vascular Diseases, Peripheral Vascular Diseases
- Being tested
- TeGeCoach
- Keywords
- PAD, Peripheral Artery Disease, Peripheral Arterial Disease
- Medical subject headings
- Peripheral Arterial Disease, Atherosclerosis, Arterial Occlusive Diseases, Vascular Diseases, Peripheral Vascular Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeGeCoachBehavioural
12-month long telephone health coaching carried out by specially trained coaches. The health coaching is a patient-centered approach based on motivational interviewing, shared decision-making and active listening techniques. Primary care physicians will be constantly involved receiving regular health reports from the coach.
The walking exercise is based on the principle of interval training. Patients will continuously wear an activity monitor device to review their exercise performance and for remote exercise monitoring by the coach. This activity information will be regularly reviewed by the coach to ensure that the patient adheres to the individual walking exercise prescription.
| Study group | Role | What they receive |
|---|---|---|
| TeGeCoach | Experimental | Home-based exercise program consisting of telephone health coaching, remote walking exercise monitoring based on wearable monitors and intensified primary care. Receives: Behavioral: TeGeCoach |
| Usual care group (TAU) | No intervention | Patients randomized to TAU receive written information about courses offered by their statutory health insurance. Health insurance companies offer a variety of courses to encourage regular exercise and to promote lifestyle changes, including SEPs (vascular and cardio exercise), physical therapy, nutritional assistance programs, smoking cessation programs, weight loss programs, and patient education programs for obesity and diabetes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in score on Walking Impairment Questionnaire (WIQ)
The patient-reported WIQ is a valid clinical tool to classify patient-perceived walking impairment in patients with PAD in terms of pain, walking speed, walking distance and the climbing of stairs. The WIQ has been shown to be responsive to treatment effects and thus can be used as an alternative to treadmill testing for an objective assessment of walking claudication.
Measured: baseline, 12-month and 24-month follow-up
Secondary outcomes (13)
Change in score on Walking Estimated Limitation Calculated by History (WELCH) questionnaire
The WELCH is a four-item questionnaire to estimate walking limitation in patients with suspected peripheral artery disease.
Measured: baseline, 12-month and 24-month follow-up
Change in score on EQ5D-5L questionnaire
The EQ5D-5L is a standardized instrument developed by the EuroQoL Group for the measurement of health-related quality of life. There are five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ5D-5L has been validated for the general German population.
Measured: baseline, 12-month and 24-month follow-up
Change in score on Short Form Health Survey (SF-12)
The SF-12 is a self-report questionnaire for the measurement of generic health status involving multiple health dimensions: physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems and mental health. SF-12 is a short version of the SF-36, with good psychometric properties. The German version has been cross-validated with the original English version.
Measured: baseline, 12-month and 24-month follow-up
Change in score on Vascular Quality of Life Questionnaire (VascuQoL-25)
The VascuQol-25 is a highly-responsive validated questionnaire for the measurement of PAD-specific health-related quality of life, with a high level of construct and convergence validity. The questionnaire consists of five domains (Activity, Symptom, Pain, Emotional and Social) and has 25 items in total.
Measured: baseline, 12-month and 24-month follow-up
Change in score on Patient Health Questionnaire (PHQ-9)
The PHQ-9 is a brief valid questionnaire for the diagnosis of depression that can also be used to identify depression outcome measures and changes over time. The German version has been validated twice.
Measured: baseline, 12-month and 24-month follow-up
Change in score on Generalized Anxiety Disorder (GAD-7) questionnaire
The GAD-7 is brief questionnaire for the detection of Generalized Anxiety Disorder, which has been validated in primary care setting and in the general population.
Measured: baseline, 12-month and 24-month follow-up
Change in score on Alcohol Use Disorders Identification Test (AUDIT-C)
The AUDIT-C is a brief screening instrument to identify harmful alcohol consumption, consisting of three questions. Regarding its psychometric properties, the AUDIT-C has been shown to be reliable and valid instrument to screen alcohol misuse in primary care settings.
Measured: baseline, 12-month and 24-month follow-up
Change in score on Fagerström Test for Nicotine Dependence (FTND)
To identify tobacco dependence, the 6-item long Fagerström Test for Nicotine Dependence (FTND) will be used, which has been shown to be validly assessing the physical addiction to nicotine.
Measured: baseline, 12-month and 24-month follow-up
Change in score on Health Literacy Questionnaire (HLQ)
The HLQ is a comprehensive tool with excellent psychometric properties for the measurement of health literacy. The HLQ examines nine dimensions of health literacy.
Measured: baseline, 12-month and 24-month follow-up
Change in score on Patient Activation Measure (PAM-13)
PAM-13 has been shown to be a valuable tool for the measurement of patient activation by dividing people into one of four activation levels. The German version has been validated, with good psychometric properties.
Measured: baseline, 12-month and 24-month follow-up
Change in utilization of medical services
Routine health insurance data: time period until hospitalization; probability of hospitalization; number and duration of inpatient hospitalization; outpatient medical treatment; drug dose (defined daily dose - DDD).
Measured: baseline, 12-month and 24-month follow-up
Change in severe (adverse) events
Routine health insurance data: death, amputation, revascularization, etc.
Measured: baseline, 12-month and 24-month follow-up
Change in total health care costs
Routine health insurance data: hospital billing and insurance reimbursement; inpatient hospital cost; inpatient rehabilitation costs; ambulatory care costs; costs for drugs and other medical supplies; sick pay costs.
Measured: baseline, 12-month and 24-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start23 Apr 2018
- Primary completion15 Feb 2021
- Study completion15 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study arms: TeGeCoach (Intervention); Treatment-as-Usual (TAU)
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,982 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jörg Dirmaier, PD Dr., Principal investigator, Universitätsklinikum Hamburg-EppendorfFrank Bienert, Study director, KKH statutory health insuranceLutz Herbarth, Dr., Study chair, KKH statutory health insurance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03496948
- Sponsor's protocol ID
- tegecoach
- Other IDs
- 01NVF17013
- Acronym
- TeGeCoach
- Status last verified
- Mar 2021
- First submitted
- 23 Mar 2018
- Last updated
- 19 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It is planned to share all individual participant data (IPD) that underlie results in a publication.
Publications
Fowkes FG, Rudan D, Rudan I, Aboyans V, Denenberg JO, McDermott MM, Norman PE, Sampson UK, Williams LJ, Mensah GA, Criqui MH. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet. 2013 Oct 19;382(9901):1329-40. doi: 10.1016/S0140-6736(13)61249-0. Epub 2013 Aug 1.
PubMed 23915883Criqui MH, Aboyans V. Epidemiology of peripheral artery disease. Circ Res. 2015 Apr 24;116(9):1509-26. doi: 10.1161/CIRCRESAHA.116.303849.
PubMed 25908725Sampson UK, Fowkes FG, McDermott MM, Criqui MH, Aboyans V, Norman PE, Forouzanfar MH, Naghavi M, Song Y, Harrell FE Jr, Denenberg JO, Mensah GA, Ezzati M, Murray C. Global and regional burden of death and disability from peripheral artery disease: 21 world regions, 1990 to 2010. Glob Heart. 2014 Mar;9(1):145-158.e21. doi: 10.1016/j.gheart.2013.12.008.
PubMed 25432124Gerhard-Herman MD, Gornik HL, Barrett C, Barshes NR, Corriere MA, Drachman DE, Fleisher LA, Fowkes FG, Hamburg NM, Kinlay S, Lookstein R, Misra S, Mureebe L, Olin JW, Patel RA, Regensteiner JG, Schanzer A, Shishehbor MH, Stewart KJ, Treat-Jacobson D, Walsh ME. 2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2017 Mar 21;135(12):e726-e779. doi: 10.1161/CIR.0000000000000471. Epub 2016 Nov 13.
PubMed 27840333Berger JS, Ladapo JA. Underuse of Prevention and Lifestyle Counseling in Patients With Peripheral Artery Disease. J Am Coll Cardiol. 2017 May 9;69(18):2293-2300. doi: 10.1016/j.jacc.2017.02.064.
PubMed 28473134Makris GC, Lattimer CR, Lavida A, Geroulakos G. Availability of supervised exercise programs and the role of structured home-based exercise in peripheral arterial disease. Eur J Vasc Endovasc Surg. 2012 Dec;44(6):569-75; discussion 576. doi: 10.1016/j.ejvs.2012.09.009. Epub 2012 Sep 30.
PubMed 23034408Harwood AE, Smith GE, Cayton T, Broadbent E, Chetter IC. A Systematic Review of the Uptake and Adherence Rates to Supervised Exercise Programs in Patients with Intermittent Claudication. Ann Vasc Surg. 2016 Jul;34:280-9. doi: 10.1016/j.avsg.2016.02.009. Epub 2016 Apr 25.
PubMed 27126713McDermott MM, Polonsky TS. Home-Based Exercise: A Therapeutic Option for Peripheral Artery Disease. Circulation. 2016 Oct 18;134(16):1127-1129. doi: 10.1161/CIRCULATIONAHA.116.023691. No abstract available.
PubMed 27754945Collins TC, Lunos S, Carlson T, Henderson K, Lightbourne M, Nelson B, Hodges JS. Effects of a home-based walking intervention on mobility and quality of life in people with diabetes and peripheral arterial disease: a randomized controlled trial. Diabetes Care. 2011 Oct;34(10):2174-9. doi: 10.2337/dc10-2399. Epub 2011 Aug 26.
PubMed 21873560Fakhry F, Spronk S, de Ridder M, den Hoed PT, Hunink MG. Long-term effects of structured home-based exercise program on functional capacity and quality of life in patients with intermittent claudication. Arch Phys Med Rehabil. 2011 Jul;92(7):1066-73. doi: 10.1016/j.apmr.2011.02.007.
PubMed 21704786Gardner AW, Parker DE, Montgomery PS, Blevins SM. Step-monitored home exercise improves ambulation, vascular function, and inflammation in symptomatic patients with peripheral artery disease: a randomized controlled trial. J Am Heart Assoc. 2014 Sep 18;3(5):e001107. doi: 10.1161/JAHA.114.001107.
PubMed 25237048Gardner AW, Parker DE, Montgomery PS, Scott KJ, Blevins SM. Efficacy of quantified home-based exercise and supervised exercise in patients with intermittent claudication: a randomized controlled trial. Circulation. 2011 Feb 8;123(5):491-8. doi: 10.1161/CIRCULATIONAHA.110.963066. Epub 2011 Jan 24.
PubMed 21262997Parmenter BJ, Dieberg G, Smart NA. Exercise training for management of peripheral arterial disease: a systematic review and meta-analysis. Sports Med. 2015 Feb;45(2):231-44. doi: 10.1007/s40279-014-0261-z.
PubMed 25230780Al-Jundi W, Madbak K, Beard JD, Nawaz S, Tew GA. Systematic review of home-based exercise programmes for individuals with intermittent claudication. Eur J Vasc Endovasc Surg. 2013 Dec;46(6):690-706. doi: 10.1016/j.ejvs.2013.09.004. Epub 2013 Sep 11.
PubMed 24076079Fokkenrood HJ, Bendermacher BL, Lauret GJ, Willigendael EM, Prins MH, Teijink JA. Supervised exercise therapy versus non-supervised exercise therapy for intermittent claudication. Cochrane Database Syst Rev. 2013 Aug 23;(8):CD005263. doi: 10.1002/14651858.CD005263.pub3.
PubMed 23970372
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PAD-TeGeCoach: Health Coaching and Telemetry Supported Walking Exercise for Improving Quality of Life
- ClinicalTrials.gov ID
- NCT03496948
- Acronym / sponsor ID
- TeGeCoach / tegecoach
- Conditions
- Peripheral Artery Disease, Atherosclerosis, Peripheral Arterial Disease, Arterial Occlusive Diseases, Vascular Diseases, Peripheral Vascular Diseases
- Keywords
- PAD, Peripheral Artery Disease, Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,982 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 23 Apr 2018 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 12 Apr 2018 (actual)
- 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.
Peripheral artery disease (PAD) is the third most prevalent cardiovascular disease worldwide, with over 200 million people affected. Most prominent symptom is leg pain while walking known as intermittent claudication. Based on the currently existing gaps in the management of intermittent claudication, the objective of the this study is to explore the clinical effectiveness and cost advantage of TeGeCoach, a 12-month long home-based exercise program, compared to usual care. TeGeCoach consists of telephone health coaching, remote walking exercise monitoring based on wearable activity monitors and intensified primary care. It is hypothesized that TeGeCoach will improve functional outcomes and will reduce total health care costs.
Detailed description
Peripheral artery disease (PAD) is the third most prevalent cardiovascular disease worldwide and has become a serious public health issue, with over 200 million people affected. Smoking and diabetes are the strongest risk factors for the development of peripheral artery disease, but also high cholesterol, high blood pressure and sedentary lifestyle. The most prominent symptom is leg pain while walking known as intermittent claudication, as the muscles do not get enough blood during exercise to meet the needs. To improve mobility, first line treatment for intermittent claudication are outpatient supervised exercise programs (SEPs); however, their implementation face manifold challenges: low patient adherence, no reimbursement by insurers, high costs of course implementation, and low course availability. These barriers led to the development of home-based exercise programs, which are similarly effective when combined with a structured approach by setting exercise goals, monitoring exercise activity, and regular follow up with a coach. Therefore, this trial aims to determine the clinical effectiveness and cost advantage of TeGeCoach, a 12-month long structured home-based exercise program (HEP), compared with usual care of intermittent claudication. It is hypothesized that TeGeCoach will improve walking impairment and will lower the need of health care resources that are spent on patients with PAD at 24-month follow-up.
The investigators will conduct a prospective, open-label, pragmatic randomized controlled clinical trial in a health insurance setting. 1760 patients with peripheral artery disease at Fontaine stage II will be randomly assigned either to TeGeCoach or Care-as-usual (usual care). TeGeCoach consists of telemonitored walking exercise using wearable activity trackers, telephone health coaching and medical supervision by a physician. The health coaching is a patient-centered approach based on motivational interviewing, shared decision-making and active listening techniques for supporting better patient engagement and activation, disease self-care, treatment adherence and lifestyle management. Depending on the individual functional status and exercise capacity, participants will be asked to walk up to seven times a week. Usual care participants regularly receive information leaflets and can access supervised exercise programs, physical therapy and a variety of programs for promoting a healthy lifestyle. Primary outcomes are functional capacity measured by the Walking Impairment Questionnaire (WIQ). Secondary outcome measures include quality of life, health literacy and health behavior. Claims data is used to collect total health care costs, healthcare resource use and (severe) adverse events. Outcomes will be measured at three time points (0, 12, and 24 months).
Clearly, the current routine care of intermittent claudication in patients with PAD is partly ineffective und insufficient, with the consequence of a poorly served patient population and worsening disease condition. TeGeCoach may provide an effective and feasible alternative in the management of intermittent claudication by improving access to supervised exercise while at the same time potentially reducing health care costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Study arms: TeGeCoach (Intervention); Treatment-as-Usual (TAU)
| Arm | Type | Receives |
|---|---|---|
| TeGeCoach | Experimental | Behavioral: TeGeCoachHome-based exercise program consisting of telephone health coaching, remote walking exercise monitoring based on wearable monitors and intensified primary care. |
| Usual care group (TAU) | No intervention | –Patients randomized to TAU receive written information about courses offered by their statutory health insurance. Health insurance companies offer a variety of courses to encourage regular exercise and to promote lifestyle changes, including SEPs (vascular and cardio exercise), physical therapy, nutritional assistance programs, smoking cessation programs, weight loss programs, and patient education programs for obesity and diabetes. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Insured with one of the three participating health insurance companies
- Sufficient German language skills to follow the telephone-based health coaching
- Access to a telephone (landline or mobile);
- Primary or secondary diagnosis of PAD at Fontaine stage IIa or IIb within the last 36 months, but no primary or secondary diagnosis of PAD at Fontaine stage I within the last 12 months; or at Fontaine stage III or IV within the last 36 months
- Inpatient and outpatient diagnoses from routine statutory health insurance data will be used to identify eligible patients.
Key exclusion criteria (8 listed)
- Immobility that goes beyond claudication (inability to carry out intervention and competing risks)
- Severe and persistent mental disorders (adherence reasons)
- Suicidality (safety reasons)
- Life-threatening somatic diseases (e.g., cancer; competing risk)
- Active or recent participation in any other PAD intervention trial
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 |
|---|---|---|
| TeGeCoach12-month long telephone health coaching carried out by specially trained coaches. The health coaching is a patient-centered approach based on motivational interviewing, shared decision-making and active listening techniques. Primary care physicians will be constantly involved receiving regular health reports from the coach. The walking exercise is based on the principle of interval training. Patients will continuously wear an activity monitor device to review their exercise performance and for remote exercise monitoring by the coach. This activity information will be regularly reviewed by the coach to ensure that the patient adheres to the individual walking exercise prescription. | Behavioural | TeGeCoach |
Primary outcome
Change in score on Walking Impairment Questionnaire (WIQ)
Time frame: baseline, 12-month and 24-month follow-up
The patient-reported WIQ is a valid clinical tool to classify patient-perceived walking impairment in patients with PAD in terms of pain, walking speed, walking distance and the climbing of stairs. The WIQ has been shown to be responsive to treatment effects and thus can be used as an alternative to treadmill testing for an objective assessment of walking claudication.
13 secondary outcomes
Change in score on Walking Estimated Limitation Calculated by History (WELCH) questionnaire
Time frame: baseline, 12-month and 24-month follow-up
Change in score on EQ5D-5L questionnaire
Time frame: baseline, 12-month and 24-month follow-up
Change in score on Short Form Health Survey (SF-12)
Time frame: baseline, 12-month and 24-month follow-up
Change in score on Vascular Quality of Life Questionnaire (VascuQoL-25)
Time frame: baseline, 12-month and 24-month follow-up
Change in score on Patient Health Questionnaire (PHQ-9)
Time frame: baseline, 12-month and 24-month follow-up
Change in score on Generalized Anxiety Disorder (GAD-7) questionnaire
Time frame: baseline, 12-month and 24-month follow-up
Change in score on Alcohol Use Disorders Identification Test (AUDIT-C)
Time frame: baseline, 12-month and 24-month follow-up
Change in score on Fagerström Test for Nicotine Dependence (FTND)
Time frame: baseline, 12-month and 24-month follow-up
Change in score on Health Literacy Questionnaire (HLQ)
Time frame: baseline, 12-month and 24-month follow-up
Change in score on Patient Activation Measure (PAM-13)
Time frame: baseline, 12-month and 24-month follow-up
Change in utilization of medical services
Time frame: baseline, 12-month and 24-month follow-up
Change in severe (adverse) events
Time frame: baseline, 12-month and 24-month follow-up
Change in total health care costs
Time frame: baseline, 12-month and 24-month follow-up
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 19 Mar 2021.
- Background: PubMed 23915883Fowkes FG, Rudan D, Rudan I, Aboyans V, Denenberg JO, McDermott MM, Norman PE, Sampson UK, Williams LJ, Mensah GA, Criqui MH. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet. 2013 Oct 19;382(9901):1329-40. doi: 10.1016/S0140-6736(13)61249-0. Epub 2013 Aug 1.
- Background: PubMed 25908725Criqui MH, Aboyans V. Epidemiology of peripheral artery disease. Circ Res. 2015 Apr 24;116(9):1509-26. doi: 10.1161/CIRCRESAHA.116.303849.
- Background: PubMed 25432124Sampson UK, Fowkes FG, McDermott MM, Criqui MH, Aboyans V, Norman PE, Forouzanfar MH, Naghavi M, Song Y, Harrell FE Jr, Denenberg JO, Mensah GA, Ezzati M, Murray C. Global and regional burden of death and disability from peripheral artery disease: 21 world regions, 1990 to 2010. Glob Heart. 2014 Mar;9(1):145-158.e21. doi: 10.1016/j.gheart.2013.12.008.
- Background: PubMed 27840333Gerhard-Herman MD, Gornik HL, Barrett C, Barshes NR, Corriere MA, Drachman DE, Fleisher LA, Fowkes FG, Hamburg NM, Kinlay S, Lookstein R, Misra S, Mureebe L, Olin JW, Patel RA, Regensteiner JG, Schanzer A, Shishehbor MH, Stewart KJ, Treat-Jacobson D, Walsh ME. 2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2017 Mar 21;135(12):e726-e779. doi: 10.1161/CIR.0000000000000471. Epub 2016 Nov 13.
- Background: PubMed 28473134Berger JS, Ladapo JA. Underuse of Prevention and Lifestyle Counseling in Patients With Peripheral Artery Disease. J Am Coll Cardiol. 2017 May 9;69(18):2293-2300. doi: 10.1016/j.jacc.2017.02.064.
- Background: PubMed 23034408Makris GC, Lattimer CR, Lavida A, Geroulakos G. Availability of supervised exercise programs and the role of structured home-based exercise in peripheral arterial disease. Eur J Vasc Endovasc Surg. 2012 Dec;44(6):569-75; discussion 576. doi: 10.1016/j.ejvs.2012.09.009. Epub 2012 Sep 30.
- Background: PubMed 27126713Harwood AE, Smith GE, Cayton T, Broadbent E, Chetter IC. A Systematic Review of the Uptake and Adherence Rates to Supervised Exercise Programs in Patients with Intermittent Claudication. Ann Vasc Surg. 2016 Jul;34:280-9. doi: 10.1016/j.avsg.2016.02.009. Epub 2016 Apr 25.
- Background: PubMed 27754945McDermott MM, Polonsky TS. Home-Based Exercise: A Therapeutic Option for Peripheral Artery Disease. Circulation. 2016 Oct 18;134(16):1127-1129. doi: 10.1161/CIRCULATIONAHA.116.023691. No abstract available.
- Background: PubMed 21873560Collins TC, Lunos S, Carlson T, Henderson K, Lightbourne M, Nelson B, Hodges JS. Effects of a home-based walking intervention on mobility and quality of life in people with diabetes and peripheral arterial disease: a randomized controlled trial. Diabetes Care. 2011 Oct;34(10):2174-9. doi: 10.2337/dc10-2399. Epub 2011 Aug 26.
- Background: PubMed 21704786Fakhry F, Spronk S, de Ridder M, den Hoed PT, Hunink MG. Long-term effects of structured home-based exercise program on functional capacity and quality of life in patients with intermittent claudication. Arch Phys Med Rehabil. 2011 Jul;92(7):1066-73. doi: 10.1016/j.apmr.2011.02.007.
- Background: PubMed 25237048Gardner AW, Parker DE, Montgomery PS, Blevins SM. Step-monitored home exercise improves ambulation, vascular function, and inflammation in symptomatic patients with peripheral artery disease: a randomized controlled trial. J Am Heart Assoc. 2014 Sep 18;3(5):e001107. doi: 10.1161/JAHA.114.001107.
- Background: PubMed 21262997Gardner AW, Parker DE, Montgomery PS, Scott KJ, Blevins SM. Efficacy of quantified home-based exercise and supervised exercise in patients with intermittent claudication: a randomized controlled trial. Circulation. 2011 Feb 8;123(5):491-8. doi: 10.1161/CIRCULATIONAHA.110.963066. Epub 2011 Jan 24.
- Individual participant dataSharing planned: Yes. It is planned to share all individual participant data (IPD) that underlie results in a publication.
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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.
Jörg Dirmaier, PD Dr. principal investigator
Universitätsklinikum Hamburg-Eppendorf
Frank Bienert study director
KKH statutory health insurance
Lutz Herbarth, Dr. study chair
KKH statutory health insurance
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TeGeCoach in people with Peripheral Artery Disease and Atherosclerosis, run by Universitätsklinikum Hamburg-Eppendorf at 3 sites in Germany.
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 5 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 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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. 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?
Change in score on Walking Impairment Questionnaire (WIQ) (time frame: baseline, 12-month and 24-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03496948, which also lists 23 linked publications.
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 19 Mar 2021.