An interventional study of TeGeCoach in Peripheral Artery Disease, Atherosclerosis and Peripheral Arterial Disease, sponsored by Universitätsklinikum Hamburg-Eppendorf. Completed at 3 sites in Germany. Open to participants aged 35 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-03-19.
Sponsored by Universitätsklinikum Hamburg-Eppendorf · Not applicable, Interventional, and Treatment
Among 173 studies in Peripheral Arterial Disease with a site in Germany — 15 open to participants now, 29 under way, 3 of them phase 3. Peripheral Arterial Disease · Germany.
Among the 173 studies in Peripheral Arterial Disease with a site in Germany, this one is the 8th largest by enrollment of the 126 interventional ones that give a count, is one of 13 that started in 2018, is one of 85 with no phase, and was the 108th registered.
1,377 studies on the registry are indexed under Peripheral Arterial Disease; 275 are open to participants now.
Browse Peripheral Arterial Disease studies →15 of the 173 studies in Peripheral Arterial Disease with a site in Germany are open now. Recruiting first, the newest first:
W.L.Gore & Associates · Sites in Germany
Ages 18+
University Hospital, Essen · Sites in Germany
Ages 18–85
Biotronik AG · Sites in Germany, Austria, Belgium and 5 more countries
Ages 18+
CSL Behring · Sites in Germany, United States, Argentina and 32 more countries
Ages 18+
University of Leipzig · Sites in Germany
Ages 18+
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 192 Peripheral Arterial Disease studies recruiting now, 138 (72%) set no upper age limit and 9 (5%) stop at 75 or younger; 13 take children under 18; 19 take healthy volunteers.
This study: 35 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
173 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 18 · Phase 3 19 · Phase 4 5
First in 2001; this study’s year is marked. 13 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 1,982 is above the median of 70 across 927 interventional studies indexed under Peripheral Arterial Disease.
Median enrollment 107 across the 126 interventional studies, 200 across the 47 observational. Of the 118 that completed or were terminated, 34 (29%) have results posted.
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113 of 173 have an industry lead sponsor. The 10 most frequent:
Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 416 studies on the registry; 86 are open to participants now.
Universitätsklinikum Hamburg-Eppendorf has 6 studies filed under Peripheral Arterial Disease — fewer than ten, so there is no comparison to draw.
4 of the studies in Peripheral Arterial Disease with a site in Germany that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04971772Cardionovum GmbHSIGNATURE Study : DCB (Legflow) vs POBA in Fempop Arteries | 2026-12 |
| NCT04110327Micro Medical Solution, Inc.An All-Comers Observational Study of the MicroStent™ Peripheral Vascular Stent System in Subjects With Peripheral Arterial Disease | 2026-12-31 |
| NCT06832631OrbusNeichVITUS Post-Market Registry | 2027-06 |
| NCT05055297M.A. Med Alliance S.A.SELUTION4BTK Trial | 2027-06-01 |
Add all 4 to your calendar (.ics) → With an account.
Among the 173 studies in Peripheral Arterial Disease with a site in Germany, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Inpatient and outpatient diagnoses from routine statutory health insurance data will be used to identify eligible patients.
Exclusion Criteria:
Ineligible patients are identified based on diagnoses that were made in inpatient settings only, given the considerable number of diagnostic errors in outpatient settings.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Home-based exercise program consisting of telephone health coaching, remote walking exercise monitoring based on wearable monitors and intensified primary care.
Behavioral: TeGeCoach
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.
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.
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.
Time frame: baseline, 12-month and 24-month follow-up
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: baseline, 12-month and 24-month follow-up
Change in severe (adverse) events
Routine health insurance data: death, amputation, revascularization, etc.
Time frame: 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.
Time frame: baseline, 12-month and 24-month follow-up
Questionnaire on Satisfaction in Outpatient Care (ZAPA; intervention arm only)
ZAPA is a brief (4 items) and psychometrically valid German questionnaire for measuring the patient's global satisfaction with his or her outpatient care, including the quality and extent of information received and his/her involvement in clinical decisions (i.e. shared-decision making).
Time frame: 12-month follow-up
Change in exercise adherence (intervention arm only)
Activity tracker data: e.g. number of alerts and corresponding phone calls made when step frequency or the duration of exercise sessions fall below an individual threshold range, amount of steps, net walking time (\> 50 steps/minute) per day/week
Time frame: baseline and 12-month follow-up
Change in amount of steps/net walking time (intervention arm only)
Coaching software data
Time frame: baseline and 12-month follow-up
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — It is planned to share all individual participant data (IPD) that underlie results in a publication.
Supporting information: Study protocol
Time frame: After study completion
Access criteria: Available upon request
Ran from Apr 2018 to primary completion in Feb 2021, 33 months.
Of 260 non-industry interventional studies with no phase under Peripheral Arterial Disease, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 64. This study's 33 months is close to that.
Counting every sponsor, half of 385 studies reached it within 31 months; a quarter within 17 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Universitätsklinikum Hamburg-Eppendorf →