Original article
Telephone Health Coaching and Remote Exercise Monitoring (TeGeCoach) in Peripheral Arterial Occlusive Disease
A Randomized Controlled Trial
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Background: Supervised exercise programs are used to treat intermittent claudication (IC). Home-based exercise programs have been developed to lower barriers to participation. We studied the effects of one such exercise program (TeGeCoach) on self-reported walking ability in patients with IC.
Methods: In a pragmatic multicenter randomized controlled trial (registration number NCT03496948), 1982 patients with symptomatic IC insured by one of three German statutory health insurance funds received either telephone health coaching with remote exercise monitoring (TeGeCoach; n = 994) or routine care (n = 988). The primary outcome was the change in Walking Impairment Questionnaire (WIQ) scores after 12 and 24 months in the intention-to-treat population. The secondary outcomes were health-related quality of life, symptoms of depression or anxiety, health competence, patient activation, alcohol use, and nicotine dependence.
Results: There was a significant group difference in WIQ score in favor of TeGeCoach (p < 0.0001), amounting to 6.30 points at 12 months (Bonferroni-corrected 95% CI [4.02; 8.59], Cohen’s d = 0.26) and 4.55 points at 24 months ([2.20; 6.91], d = 0.19). Some of the secondary outcomes also showed positive results in favor of TeGeCoach at 12 months with small effect sizes (d ≥ 0.20), including physical health–related quality of life and patient activation. The average daily step count was not higher in the TeGeCoach group.
Conclusion: Significant improvements regarding symptom burden demonstrate the benefit of a home-based exercise program and thus expand the opportunities for guideline-oriented treatment of IC. Future studies should additionally address the effect of home-based exercise programs on clinical variables by means of, for example, the 6-minute walk test.


Peripheral arterial occlusive disease (PAOD) affects over 200 million people worldwide (1) and poses substantial challenges for healthcare systems (2). PAOD is characterized by progressive occlusion of the arteries of the legs, usually caused by atherosclerotic plaques (3). Approximately 10–30% of patients experience intermittent claudication (IC) (4, 5), exercise-induced limb pain that subsides with rest.
Supervised exercise programs (SEPs) have been shown to be effective for the treatment of IC (6) and are recommended in clinical guidelines (7, 8). However, SEPs face barriers to widespread adoption such as limited availability, lack of reimbursement, and poor patient adherence (9, 10, 11). Consequently, home-based exercise programs (HEPs) have emerged as viable alternatives that require fewer resources than conventional SEPs. Systematic reviews of randomized controlled trials have demonstrated the benefits of HEPs for the treatment of IC (6, 12, 13, 14, 15), including programs employing activity trackers for self-monitoring and telemonitoring (16, 17). However, more high-quality evidence is needed to guide their application in clinical practice.
This pragmatic trial aimed to evaluate the effectiveness of a HEP that integrates telemedicine-supported exercise, telephone health coaching, and medical care (TeGeCoach) into routine clinical practice. The primary outcome is self-reported walking ability measured by means of the Walking Impairment Questionnaire (WIQ), while the secondary outcomes include, for example, quality of life, mental health, health competence, patient activation, and health-related risk behaviors.
Methods
Design
The TeGeCoach trial was an open-label randomized controlled parallel-group superiority trial with 1982 participants carried out in collaboration with three statutory health insurance funds (SHIs): the Kaufmännische Krankenkasse (KKH), the Techniker Krankenkasse (TK), and the mhplus Betriebskrankenkasse (MH). The SHIs were responsible for recruitment and the implementation of the intervention. Ethical approval was obtained from the Ethics Committee of the Medical Association of Hamburg (reference no. PV5708). The trial was registered on ClinicalTrials.gov (NCT03496948), and the trial protocol was published in a peer-reviewed journal (18). Additional details about the methods can be found in the eSupplement.
Participants
Eligible patients aged 35–80 years who spoke German and had access to a telephone were recruited on the basis of SHI claims data (ICD-10-GM codes). They were required to have a physician-confirmed diagnosis of PAOD at IC stage (Fontaine stage IIa or IIb) within the previous 36 months. Patients with asymptomatic PAOD in the past 12 months (Fontaine stage I), or rest pain in the past 36 months (Fontaine stage III or IV) were excluded. Patients with comorbidities that precluded the intervention were also excluded, as were those participating in other PAOD studies. All enrolled patients gave their written informed consent.
Intervention
TeGeCoach
The TeGeCoach intervention involved participants receiving telephone health coaching. Based on the transtheoretical model of behavioral change, the elements used were motivational interviewing, goal setting, and health education. The program included five educational modules delivered across nine telephone sessions by licensed health coaches at three telemedicine centers in Germany (eSupplement-Table 1).
Participants were directed to engage in intermittent walking exercise at an intensity eliciting maximal tolerable claudication on at least 5 days each week. Exercise levels were initially determined based on baseline capacity, with the goal of gradually increasing exercise duration to advance to the next level (15 min per daily exercise session for level A, 30 min for level B, and 60 min for level C). The use of activity trackers enabled remote monitoring of exercise training and daily activity, accompanied by medical supervision by a physician (eSupplement). After 12 months, participants had no further direct contact with their coaches but could continue monitoring themselves using their activity tracker. Moreover, the participants had access to usual care.
Usual care
The comparison group received the usual medical care under the statutory healthcare system.
Outcomes
Participants completed paper-based questionnaires at baseline and after 12 and 24 months. The primary outcome was walking ability as measured using the WIQ (19), a validated tool for assessing walking distance, walking speed, and stair climbing. The WIQ score is responsive to the effects of exercise interventions (20, 21), and correlates with objective measures of walking ability (22, 23, 24) and with the ankle–brachial index (25). Secondary outcomes included health-related quality of life, depression and anxiety symptoms, health literacy, patient activation, alcohol use, nicotine dependence, and program satisfaction (only in the TeGeCoach arm). Detailed descriptions of the secondary outcomes can be found in the study protocol (18). The health economic analysis of TeGeCoach has been published separately (26).
Intervention access and use
For safety reasons, participants in the TeGeCoach arm needed to be supervised by a physician close to their home. They had the option of choosing their own physician or being assigned to a physician by their health coach. Participants without a physician referral had no access to TeGeCoach, although they remained in the study, i.e., they were included in the effectiveness cohort.
Owing to the pragmatic study design, the degree of program penetration was calculated based on the proportion of participants successfully referred to a physician, as not all patients could be assigned to a suitable physician close to their place of residence. Coaching fidelity was assessed as the number of coaching sessions completed per participant. Exercise activity in the TeGeCoach arm was measured using the logs from the activity trackers, including the longest daily exercise session and the average number of steps taken per day. Patient ratings of intervention satisfaction are summarized descriptively in the eSupplement-Results.
Statistical methods
The trial aimed to detect a small to moderate group difference (f = 0.15) with 80% power and a significance level of 5%. The expected attrition rates of 70% (TeGeCoach arm) and 80% (usual care) necessitated a minimum of 1760 participants (880 per arm).
Primary and secondary outcomes were analyzed in the intention-to-treat (ITT) population, i.e., including all participants who had provided questionnaire data at baseline (the so-called effectiveness cohort). Linear mixed models were used to compare changes between the study arms. To account for missing data, the models were fitted with restricted maximum likelihood estimation (REML) using the lme4 package in R (27). Time, SHI, and the interaction between study group and time were specified as fixed effects, with random intercepts at participant level.
The outcomes were also analyzed in a modified ITT (mITT) population and a per protocol (PP) population. The mITT population comprised the participants who were assigned to a physician and had access to TeGeCoach, while the PP population was made up of participants who had completed nine coaching calls. Statistical tests were conducted at a two-sided significance level of 5%, and post-hoc contrasts in the primary analyses were adjusted using Bonferroni correction for two comparisons. The secondary outcomes were not adjusted for multiple testing and should be interpreted as exploratory. Effect sizes were calculated using Cohen’s d, dividing the model estimates by the pooled standard deviation at baseline.
Results
The participant flow throughout the trial (April 2018–February 2021) is shown in the eSupplement-Figure 1. Further details of intervention delivery, including graphical representations of activity parameters and the use of courses and programs forming part of usual care, are shown in the eSupplement-Results.
Treatment effectiveness
The ITT population comprised 806 participants in the TeGeCoach arm and 879 participants in the usual care arm who provided baseline data, accounting for 85% of the randomized sample (effectiveness cohort). In the effectiveness cohort, the program penetration rate for the TeGeCoach arm was 73.2% (n = 590). The baseline characteristics were well balanced between the two arms, with the exception of revascularizations, which were slightly more frequent in the TeGeCoach arm (31.6% vs. 27.5%, Table 1). However, the number of patients who underwent revascularization during the study period was low and similar between the groups (eSupplement-Table 3).
The Figure shows the estimated means in both arms at baseline, 12 months, and 24 months for the primary outcome, the WIQ total score. In the TeGeCoach arm, walking ability had improved by 8.40 points at 12 months (95% CI [6.93; 9.86]) and 6.18 points at 24 months (95% CI [4.64; 7.71) relative to baseline. In the usual care arm, walking ability had improved by 2.09 points at 12 months (95% CI [0.73; 3.45]) and 1.62 points at 24 months (95% CI [0.25; 2.99]) relative to baseline. The difference in change between the groups was in favor of TeGeCoach and statistically significant (F = 15.02, p < 0.0001). Specifically, the group difference was 6.30 points at 12 months (two-test Bonferroni-corrected 95% CI [4.02; 8.59], p < 0.0001, d = 0.26) and 4.55 points at 24 months (two-test Bonferroni-corrected 95% CI [2.20; 6.91], p ≤ 0.0001, d = 0.19).
These results were supported by the WIQ subscales of walking distance and speed and by several secondary outcomes that showed at least small effects (d > 0.20) in favor of TeGeCoach, including measures of physical health-related quality of life and patient activation (Table 2). The treatment effects were more pronounced in the mITT and PP populations (eSupplement-Tables 4 and 5) and remained largely consistent when adjusted for self-reported revascularizations (eSupplement-Tables 6–8). Moderation analyses showed no significant differences by gender, age, BMI, or revascularization status (eSupplement-Table 9). Subgroup analyses revealed some variations in treatment effects based on the initially assigned exercise level (eSupplement-Table 10).
Discussion
The results demonstrate the effectiveness of TeGeCoach in improving the walking ability (WIQ) of patients with PAOD and IC. The intervention showed both immediate and long-term improvements in pain-free walking distance, in alignment with the primary treatment goal and outcome measures for exercise interventions in IC (28). Additionally, the lower 95% CI limits exceeded the minimum clinically important difference (MCID) on the WIQ walking distance and walking speed subscales following exercise interventions (29). This indicates that the improvements were viewed as clinically meaningful by the patients. This is an interesting finding, considering that despite objective clinical improvements the patients themselves often perceive no change or even deterioration in their walking ability following exercise interventions (20).
Furthermore, TeGeCoach had positive effects (d > 0.20) on measures of quality of life (SF-12 and VascuQoL-25) and patient activation (PAM-13). However, it is important to note that there was no noticeable increase in the daily number of steps, suggesting that an improvement in pain-free walking distance and walking duration does not necessarily translate to increased daily activity. This observation is in line with results from previous studies that found either minimal correlation between physical exercise capacity and daily activity (30) or no significant effects of walking exercise sessions on the daily number of steps in patients with IC (31, 32).
Comparison of TeGeCoach with other HEPs provides insights into its mechanism responsible for improving walking ability. Two previous HEP trials that also employed activity trackers found negligible to moderate effects on the WIQ subscales walking distance (d = 0.16 and 0.50) and walking speed (d = 0.05 and 0.45) subscales compared with control groups without exercise (31, 33). HEPs that are similar to TeGeCoach and have proven effective in improving walking ability typically incorporate behavioral change techniques such as self- and remote monitoring with wearable activity trackers, goal setting, education counseling, and feedback components (16, 17, 34). Additionally, effective HEPs involve high-intensity interval walking exercises up to the point of moderate to maximum claudication pain, usually performed at least three times a week (35). The inclusion of telephone health coaching informed by motivational interviewing may well have reinforced the positive effects of exercise by promoting behavior change and, consequently, increasing physical activity (36).
The primary strength of this trial is its unique scale, with the largest sample size, longest program duration, and longest available follow-up among HEP studies involving patients with PAOD and IC. With its pragmatic design, this is also the first study to demonstrate the effectiveness of a telemedicine-delivered HEP implemented in a primary healthcare setting, emphasizing the great potential of such programs for translation into clinical practice. By enabling patients to exercise at their own convenience, TeGeCoach has the potential to improve adherence and long-term engagement with exercise therapy. Furthermore, TeGeCoach can be easily disseminated to a large number of patients, ensuring access to effective exercise therapy regardless of their geographical location. Additionally, health care costs and utilization of health care services, including hospitalizations, were similar between the study groups, underlining the potential for future program implementation (26).
Nevertheless, it is important to acknowledge some limitations. Although self-reported walking ability is an important outcome measure, future research should include objective clinical measurement of walking performance (e.g., the 6-minute walk test). However, the primary outcome, the WIQ total score, has demonstrated responsiveness to exercise therapy (20, 21), and is generally employed as a secondary outcome in exercise trials (33). Furthermore, the low enrollment rate (3.1%) represents a significant limitation to the study’s external validity, probably due to the impersonal recruitment approach in which potential participants received invitations via mail from their SHI. Due to the pragmatic, health insurance-based approach, patients were not personally recruited by researchers or medical staff (such as study nurses or physicians). In contrast to other HEP studies with recruitment by physicians or via appeals in the media (33, 37), the target group was not limited to motivated persons who showed interest in an exercise program; rather, participation was offered to the whole cohort of patients with PAOD and IC insured by one of the participating SHIs.
Another factor that may have discouraged participation in the study was the high level of effort required to actively participate in the intervention, including coaching calls and regular exercise sessions. This highlights the challenges of motivating patients with PAOD and IC to partake in exercise programs (38), partly due to their reluctance to incur exercise-induced pain (11). Additionally, persons who were invited to participate cited various barriers, including technology concerns, worries about privacy with regard to monitoring, lack of awareness of having PAOD, and the presence of other medical conditions. Future studies could adopt a more personal approach, with the study team discussing participation directly with eligible patients and addressing their concerns.
Another problem is the significant number of patients unable to access TeGeCoach due to a lack of suitable medical personnel. This highlights the complexity of implementation of exercise-based interventions for patients with PAOD in the primary care setting, which entails administrative demands. Further research is needed to evaluate the practical applicability of TeGeCoach.
Lastly, the COVID-19 pandemic may have had an impact on the study outcomes. However, the pandemic emerged only after conclusion of the intervention for all participants, i.e., after the 12-month results. While the pandemic may have influenced the 24-month outcomes, it is important to emphasize that the two groups were affected in equal measure, with the study participants able to exercise independently at any time.
Data sharing
De-identified data will be made available to researchers upon reasonable request during the period 3 months to 5 years after publication of this article. Prior to obtaining access to the data, interested researchers must submit a methodologically sound analysis proposal and sign a data access agreement. Requests for data access should be directed to the corresponding author (f.rezvani@uke.de).
Funding
This study was funded by the Innovation Fund (grant number 01NVF17013) of the Federal Joint Committee (G-BA).
Ethical approval
This study was approved by the Ethics Committee of the Medical Association of Hamburg (reference number PV5708).
Acknowledgment
We are sincerely grateful to the patients and persons who contributed to the implementation of the TeGeCoach trial at each telemedicine center. Special thanks go to Finja Mäueler, who assisted us in the preparation of the manuscript with great enthusiasm and commitment.
Conflict of interest statement
MDA is spokesman for digitalization of the Baden–Württemberg State Ministry for Social Affairs, Health, and Integration and spokesman of Forum Health Region Baden–Württemberg. He is chair of the Digital Health Association Baden–Württemberg, chair of the Southwest German Society of Internal Medicine, board member and past president of the German Society for Nephrology, and chair of the Hospitals Committee of the Baden–Württemberg Medical Association.
BF has received institutional support for the development of telemedical programs, including programs based on the TeGeCoach project, from the Innovation Fund of the G-BA and from the fund established by the Hospital Future Act.
The remaining authors declare that no conflict of interest exists.
Received on 29 June 2023, revised version accepted on 16 January 2024
Corresponding author
Farhad Rezvani
Universitätsklinikum Hamburg-Eppendorf
Institut und Poliklinik für Medizinische Psychologie
Martinistr. 52
20251 Hamburg, Germany
f.rezvani@uke.de
Cite this as:
Rezvani F, Heider D, König HH, Herbarth L, Steinisch P, Schuhmann F, Böbinger H, Krack G, Korth T, Thomsen L, Chase DP, Schreiber R, Alscher MD, Finger B, Härter M, Dirmaier J: Telephone health coaching and remote exercise monitoring (TeGeCoach) in peripheral arterial occlusive disease—a randomized controlled trial. Dtsch Arztebl Int 2024; 121: 323–30. DOI: 10.3238/arztebl.m2024.0008
Department of Medical Psychology, University Medical Center Hamburg-Eppendorf: Farhad Rezvani, Prof. Dr. med. Dr. phil. Martin Härter, PD Dr. phil. Jörg Dirmaier
Department of Health Economics and Health Services Research, University Medical Center Hamburg-Eppendorf: Dr. rer. medic. Dirk Heider, Prof. Dr. med. Hans-Helmut König
KKH Health Insurance Fund, Hanover: Dr. med. Lutz Herbarth, Patrick Steinisch
TK Technicians’ Health Insurance Fund, Hamburg: Franziska Schuhmann, Hannes Böbinger
mhplus Health Insurance Fund, Ludwigsburg: Dr. Gundula Krack
IEM GmbH, Aachen: Thomas Korth
Philips GmbH Market DACH, Hamburg: Lara Thomsen, Daniela Patricia Chase, Robert Schreiber
Robert Bosch Society for Medical Research, Bosch Health Campus GmbH, Stuttgart: Prof. Dr. med. Mark-Dominik Alscher, Benjamin Finger
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