Telephone Health Coaching and Remote Exercise Monitoring for Peripheral Artery Disease

NCT03496948 | Completed

• 2 other identifiers: tegecoach01NVF17013
• Study Type: interventional
• Target: 1,982
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Peripheral Artery Disease; Atherosclerosis; Peripheral Arterial Disease; Arterial Occlusive Diseases; Vascular Diseases; Peripheral Vascular Diseases; Cardiovascular Diseases

Keywords

PAD; Peripheral Artery Disease; Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline, 12-month and 24-month follow-up

Secondary Outcomes (13)

• Change in score on Walking Estimated Limitation Calculated by History (WELCH) questionnaire

  baseline, 12-month and 24-month follow-up

• Change in score on EQ5D-5L questionnaire

  baseline, 12-month and 24-month follow-up

• Change in score on Short Form Health Survey (SF-12)

  baseline, 12-month and 24-month follow-up

• Change in score on Vascular Quality of Life Questionnaire (VascuQoL-25)

  baseline, 12-month and 24-month follow-up

• Change in score on Patient Health Questionnaire (PHQ-9)

  baseline, 12-month and 24-month follow-up

Other Outcomes (3)

• Questionnaire on Satisfaction in Outpatient Care (ZAPA; intervention arm only)

  12-month follow-up

• Change in exercise adherence (intervention arm only)

  baseline and 12-month follow-up

• Change in amount of steps/net walking time (intervention arm only)

  baseline and 12-month follow-up

Study Arms (2)

TeGeCoach

EXPERIMENTAL

Home-based exercise program consisting of telephone health coaching, remote walking exercise monitoring based on wearable monitors and intensified primary care.

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.

Interventions

TeGeCoach BEHAVIORAL

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.

TeGeCoach

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (3)

TK statutory health insurance

Hamburg, 22305, Germany

Location

KKH statutory health insurance

Hanover, 30625, Germany

Location

Mhplus Statutory Health Insurance

Nuremberg, 90411, Germany

Location

Related Publications (23)

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• Gerhard-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.

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• Berger 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.

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• Makris 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.

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• Harwood 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.

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• McDermott 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.

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• Collins 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.

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• Fakhry 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.

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• Gardner 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.

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• Gardner 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.

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• Parmenter 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.

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• Al-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.

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• Fokkenrood 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.

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• Normahani P, Kwasnicki R, Bicknell C, Allen L, Jenkins MP, Gibbs R, Cheshire N, Darzi A, Riga C. Wearable Sensor Technology Efficacy in Peripheral Vascular Disease (wSTEP): A Randomized Controlled Trial. Ann Surg. 2018 Dec;268(6):1113-1118. doi: 10.1097/SLA.0000000000002300.

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• McDermott MM, Domanchuk K, Liu K, Guralnik JM, Tian L, Criqui MH, Ferrucci L, Kibbe M, Jones DL, Pearce WH, Zhao L, Spring B, Rejeski WJ. The Group Oriented Arterial Leg Study (GOALS) to improve walking performance in patients with peripheral arterial disease. Contemp Clin Trials. 2012 Nov;33(6):1311-20. doi: 10.1016/j.cct.2012.08.001. Epub 2012 Aug 7.

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• McDermott MM, Guralnik JM, Criqui MH, Ferrucci L, Zhao L, Liu K, Domanchuk K, Spring B, Tian L, Kibbe M, Liao Y, Lloyd Jones D, Rejeski WJ. Home-based walking exercise in peripheral artery disease: 12-month follow-up of the GOALS randomized trial. J Am Heart Assoc. 2014 May 21;3(3):e000711. doi: 10.1161/JAHA.113.000711.

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• Harter M, Dirmaier J, Dwinger S, Kriston L, Herbarth L, Siegmund-Schultze E, Bermejo I, Matschinger H, Heider D, Konig HH. Effectiveness of Telephone-Based Health Coaching for Patients with Chronic Conditions: A Randomised Controlled Trial. PLoS One. 2016 Sep 15;11(9):e0161269. doi: 10.1371/journal.pone.0161269. eCollection 2016.

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• Kivela K, Elo S, Kyngas H, Kaariainen M. The effects of health coaching on adult patients with chronic diseases: a systematic review. Patient Educ Couns. 2014 Nov;97(2):147-57. doi: 10.1016/j.pec.2014.07.026. Epub 2014 Aug 1.

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• Heider D, Rezvani F, Matschinger H, Dirmaier J, Harter M, Herbarth L, Steinisch P, Bobinger H, Schuhmann F, Krack G, Korth T, Thomsen L, Chase DP, Schreiber R, Alscher MD, Finger B, Konig HH. The effect of telephone health coaching and remote exercise monitoring for peripheral artery disease (TeGeCoach) on health care cost and utilization: results of a randomized controlled trial. Eur J Health Econ. 2024 Jun;25(4):615-629. doi: 10.1007/s10198-023-01616-4. Epub 2023 Jul 10.

  PMID: 37428355 DERIVED

• Rezvani F, Heider D, Harter M, Konig HH, Bienert F, Brinkmann J, Herbarth L, Kramer E, Steinisch P, Freudenstein F, Terhalle R, Grosse Y, Bock S, Posselt J, Beutel C, Reif F, Kirchhoff F, Neuschwander C, Loffler F, Brunner L, Dickmeis P, Heidenthal T, Schmitz L, Chase DP, Seelenmeyer C, Alscher MD, Tegtbur U, Dirmaier J. Telephone health coaching with exercise monitoring using wearable activity trackers (TeGeCoach) for improving walking impairment in peripheral artery disease: study protocol for a randomised controlled trial and economic evaluation. BMJ Open. 2020 Jun 4;10(6):e032146. doi: 10.1136/bmjopen-2019-032146.

  PMID: 32503866 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease; Atherosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Peripheral Vascular Diseases; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Arteriosclerosis

Study Officials

• Jörg Dirmaier, PD Dr.

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

• Frank Bienert

  KKH statutory health insurance

  STUDY DIRECTOR

• Lutz Herbarth, Dr.

  KKH statutory health insurance

  STUDY CHAIR

Study Design

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

Model Details: Study arms: TeGeCoach (Intervention); Treatment-as-Usual (TAU)

Study Record Dates

• First Submitted: March 23, 2018
• First Posted: April 12, 2018
• Study Start: April 23, 2018
• Primary Completion: February 15, 2021
• Study Completion: February 15, 2021
• Last Updated: March 19, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After study completion
• Access Criteria: Available upon request

Locations

DE (3)