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European Journal of Heart Failure 2007 9(11):1104-1111; doi:10.1016/j.ejheart.2007.07.018
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© 2007 European Society of Cardiology

Adherence, adaptation and acceptance of elderly chronic heart failure patients to receiving healthcare via telephone-monitoring

Robyn A. Clarka,b, Julie J. Yallopc,d, Leon Pitermane, Joanne Croucherc, Andrew Tonkinc, Simon Stewartf, Henry Krumc,* CHAT Study Team

a National Heart Foundation South Australian Branch Australia
b Faculty of Health Sciences, University of South Australia Australia
c Department of Epidemiology and Preventive Medicine, Faculty of Medicine, Nursing and Health Sciences, Monash University Prahran, Victoria, Australia
d Department of General Practice & Primary Health Care, The University of Auckland New Zealand
e School of Primary Health Care, Faculty of Medicine, Nursing and Health Sciences, Monash University East Bentleigh, Vic, Australia
f Department of Preventative Cardiology, Baker Heart Research Institute Prahran Victoria, Australia

* Corresponding author. Department of Epidemiology and Preventive Medicine, Monash University, 3rd Floor, Burnet Tower, AMREP Precinct, Commercial Road, Melbourne, VICTORIA 3004, Australia. Tel.: +61 9903 0046; fax: +61 9903 0576. E-mail address: henry.krum{at}med.monash.edu.au


   Abstract
Top
 Abstract
1. Introduction
 2. Methods
 3. Results
 4. Discussion
 5. Conclusion
 References
 
Background: Although the potential to reduce hospitalisation and mortality in chronic heart failure (CHF) is well reported, the feasibility of receiving healthcare by structured telephone support or telemonitoring is not.

Aims: To determine; adherence, adaptation and acceptability to a national nurse-coordinated telephone-monitoring CHF management strategy. The Chronic Heart Failure Assistance by Telephone Study (CHAT).

Methods: Triangulation of descriptive statistics, feedback surveys and qualitative analysis of clinical notes. Cohort comprised of standard care plus intervention (SC+I) participants who completed the first year of the study.

Results: 30 GPs (70% rural) randomised to SC+I recruited 79 eligible participants, of whom 60 (76%) completed the full 12month follow-up period. During this time 3619 calls were made into the CHAT system (mean 45.81 SD±79.26, range 0–369), Overall there was an adherence to the study protocol of 65.8% (95% CI 0.54–0.75; p=0.001) however, of the 60 participants who completed the 12month follow-up period the adherence was significantly higher at 92.3% (95% CI 0.82–0.97, p≤0.001). Only 3% of this elderly group (mean age 74.7±9.3years) were unable to learn or competently use the technology. Participants rated CHAT with a total acceptability rate of 76.45%.

Conclusion: This study shows that elderly CHF patients can adapt quickly, find telephone-monitoring an acceptable part of their healthcare routine, and are able to maintain good adherence for a least 12months.

Key Words: Chronic heart failure • Telephone support • Acceptance

Received February 1, 2007; Revised May 27, 2007; Accepted July 16, 2007


   1. Introduction
Top
 Abstract
 1. Introduction
2. Methods
 3. Results
 4. Discussion
 5. Conclusion
 References
 
CHF affects up to 2% of the adult population and this rate is consistent throughout the world [1-3]. The effectiveness of multidisciplinary non-pharmacological approaches for improving outcomes in patients with chronic CHF have been well established in over 30 randomised trials [4-8]. However, as most of these trials have tested multi-faceted approaches it is difficult to identify the incremental benefits of the particular components of each intervention [9].

Nevertheless, it is clear that within most populations there is limited access to these programmes due to barriers related to funding and/or geography [10]. As a result, there is increasing interest in care-delivery models which incorporate information/communication technology, either in the form of telemonitoring—the transfer of physiological data (such as blood pressure, weight, electrocardiogram, oxygen saturation) via normal telephone lines or digital cable (or satellite) from home to health care provider—or simply standard telephone contacts between patients and health care providers, which may or may not include data transfer.

A recent systematic review of telemonitoring and structured telephone (as opposed to non-specific telephone conversations) has shown significant potential for the use of this technology within a CHF disease management programme [11].

The impact of structured telephone support on the risk of CHF-related hospitalisations can be attributed in part to the triage of patients at the first sign of clinical deterioration by the specialist nurse, and the consequent immediate intervention of a primary care physician [12,13]. Alternatively "telemonitoring" trials involving daily transmission of vital signs, symptoms and weight lead to earlier detection and management of clinical deterioration by both the patient and/or the managing health professional [14,15]. A recent study from Spaeder reported that symptoms indicating deterioration in heart failure were detected 8-12 days before admission to hospital [16].

Although the potential to reduce mortality and hospitalisation in CHF is well reported in these trials, the acceptability and adherence and satisfaction of receiving healthcare by telephone or telemonitoring are not [11,17]. Consequently, this study reviewed the involvement of participants in the Chronic Heart Failure Assistance by Telephone study (CHAT) [18-20] with the following aims:

  1. To determine the adherence (compliance) of participants to the CHAT study protocol by reviewing call patterns and rates and to determine if there were any significant demographic characteristics within various levels of adherence.
  2. To determine the adaptation rates within our study population and to describe the characteristics of participants who could not learn or master the use of the technology and
  3. To determine the acceptability (satisfaction) of participants to receiving healthcare via an IT supported computerized telephone-monitoring system of care including telephone interaction with specialist CHF nurses.


   2. Methods
Top
 Abstract
 1. Introduction
 2. Methods
3. Results
 4. Discussion
 5. Conclusion
 References
 
To address these aims a mixed method, triangulation [21] of descriptive statistics, qualitative analysis of the participants' feedback and clinical notes was used. The sample for this study was taken from participants who completed the first 12 months of follow-up in the Chronic Heart Failure Assistance by Telephone (CHAT) study. During the first year of this study participants were pre-dominantly recruited from rural and remote areas throughout Australia.

2.1. The CHAT study
The CHAT study is an Australian national, stratified, cluster randomised trial (cRCT) involving 400 General Practitioners (GPs). The overall study target was to recruit a total of 534 eligible patients [18]. Inclusion criteria were; age≥18 years; confirmed diagnosis of CHF by echocardiograph (LV Ejection Fraction≤40% for systolic dysfunction or features of diastolic dysfunction) and /or a primary hospital diagnosis; New York Heart Association (NYHA) Class II-IV. Patients were also required to have a touch dial phone and be able to operate it. Exclusion criteria were; enrolment in any other CHF disease management programme; planned cardiac surgery or coronary angioplasty within the next 3 months; hypertrophic cardiomyopathy or constrictive pericarditis; eligible for transplantation; life expectancy <12 months; untreated thyroid disease; pregnancy or peripartum cardiomyopathy; other problem likely to limit compliance. All GPs volunteered to participate and each GP practice was randomised to one arm of the trial by computer generated allocation. Although neither GPs nor participants were blinded, the research assistant who collected all health related quality of life (HRQOL) data was blinded to participant group allocation. In addition, adequate measures were taken to conceal the study group allocation to those who evaluated and administered the process. (Fig. 1) The primary outcome was to determine whether the intervention improved the participants' health status using the Packer Clinical Composite Score [22]. Secondary outcomes included total hospitalised days, the proportion of participants on target doses of ACE inhibitors, changes in brain natriuretic peptide (BNP) levels and cost-effectiveness. A detailed methodology paper has been published [18] and final outcomes will be presented in future publications.


Figure 01
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  		Fig. 1 CHAT study design.

 
2.1.1. Intervention
The CHAT study interventions and timings are presented in Fig. 1. All participants received standard care (SC) and those allocated to the intervention group also received nurse-coordinated telephone-monitoring support (SC+I). The telecommunication software used in the CHAT study was adapted and modified (Australian language and metric measurements), from the John Hopkins TeleWatch– software [23].

Upon enrolment, each participant in the intervention group received an initiation and training call from the nurse to ensure competence in the independent use of the telephone technology. Once initiated, participants were instructed to call at least monthly or more often if they wished. Monthly reporting was considered by the research team as the minimum contact time. Patients were required to respond to pre-recorded questions on the computer, using the telephone key pad. The questions, which were based on the national CHF guidelines [24,25], included assessment of weight, signs, symptoms and reports on self-management issues such as medicine, diet and fluids. A toll free number was provided for a period of 12-months follow-up (Fig. 1).

2.1.2. Measurement of adherence to telephone-monitoring
Adherence was calculated from the total number of calls per participant. The study protocol required the participant to call the CHAT line at least monthly, during the pre-determined 12 month follow-up period. Two scales of adherence were used: 12 calls or more was classified as "Adherence" to the study protocol and 11 calls or less was rated as "Non Adherence". Potential correlations between adherence patterns and participant baseline demographics were examined in order to determine if there were differential characteristic in the adherent and non-adherent groups.

2.1.3. Measurement of adaptation to telephone-monitoring
Data from three sources were used to identify participants who were unable to learn or master the use of the CHAT technology. (1) Response to the pre-recorded question asking the participant if they had any difficulties using the system and a second question which asked how many times they had attempted to call-in before being connected. (2) Clinical notes recorded by the CHAT nurse during all telephone interactions with the participant. (3) Six questions from the acceptability survey which related to difficulty in using the system.

2.1.4. Measurement of acceptability of telephone-monitoring
To determine the acceptability (participant's satisfaction) of receiving healthcare via telephone interaction with specialist CHF nurses, a questionnaire was developed, using a 27-item satisfaction tool adapted from the original John Hopkins' project [23]. A five point Likert scale was used. For negatively worded items, the scores were reversed so that high scores always indicated satisfaction and to assist with Factor Analysis [26]. The questionnaire was administered by telephone; within approximately 2-3 weeks of completion of the study by an independent researcher after the final 12 month HRQOL survey had been performed.

2.1.5. Statistical analysis
Data were analysed using the Statistical Package for Social Science– (Version 14 2004) and the STATA Statistical software for professionals (Version 9 2006). Descriptive statistics are presented as means, percents or proportions with 95% confidence intervals. The relationship between adherence and participant characteristics was examined using Chi square (X2) tests and STATA was also used to determine a cumulative incident probability by Poisson negative binomial regression analysis. An exploratory factor analysis was completed to determine whether scale items measured a single construct and whether those items truly measured a separate construct than other domains. Cronbach's Alpha coefficient was calculated to measure the reliability of the multidimensional aspects of the acceptance survey. Cronbach’s Alpha coefficient was calculated to measure the reliability of the multidimensional aspects of the acceptance survey. Cronbach's Alpha should be above 0.7, however Cronbach’s Alpha coefficient is quite sensitive to the number of items in the scale and short scales can have low Cronbach’s Alpha coefficient values of less than 0.5. Clinical notes were analysed using a qualitative iterative strategy based upon the method proposed by Huberman and Miles [27]. Using an iterative approach, emerging patterns and themes were identified. Eleven themes describing the subjects of the outgoing calls were identified.

2.1.6. Ethics
Ethics approval was gained from all of the institutions involved in this research including Monash University, The University of South Australia and the Aboriginal Health Council of South Australia. Individual informed consent was obtained, from each participant, by their GP during a recruitment interview.


   3. Results
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
4. Discussion
 5. Conclusion
 References
 
Between May 4th 2004 and May 2nd 2005, 79 eligible participants with a diagnosis of CHF were recruited by the 30 GPs who were randomised to the SC+I group. Within the SC+I group 19 patients (24%) withdrew from the study during the first 12 months. The remaining 60 patients (76%) completed the 12 month follow-up period. Reasons for non-completion included withdrawal due to poor health; difficulty with understanding and speaking English on the telephone; transfer to a nursing home; some finding the programme not acceptable and death. The overall withdrawal rate for voluntary reasons was 11%.

The mean age of the participants was 74.7 (SD± 9.3) years. There were 51(65%) males and 28 (35%) females. Fifty eight participants (74%) lived with a spouse, partner or a supportive relative; and nearly 70% were from rural or remote areas. Mean weight was 83 ±24 kg and NYHA class ranged from II (42%) to IV (18%). The most common co-morbidities were hypertension (58%), ischaemic heart disease (68%) and myocardial infarction (54%). (Table 1)


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  		Table 1 Baseline characteristics of the CHAT study first year cohort

 
3.1. Adherence
During the first 12 months, a total of 3619 calls were made by the 79 SC+I participants into the CHAT telemonitoring system (mean 45.81, range 0-369 calls per patient). There were 9 outliers who called almost daily during the study, with between 115 and 369 calls over 12 months. When these outliers were excluded from the analysis, the mean call rate per participant was 20.9 (range 0-94). Overall the adherence to the CHAT study protocol was satisfactory with 52 of the 79 participants classed as adherent to the CHAT telemonitoring protocol in the first year (65.8%, 95% CI 0.54-0.75, p≤0.001). However, within the group of 60 participants who completed the first 12 months of follow-up (minimum monthly contact) the adherence was significantly higher at 92.3% (95% CI 0.82-0.97, p≤0.001). There was no significant correlation between any baseline characteristics in those participants who maintained adherence to the study protocol and those who were not adherent.

3.2. Adaptation
Of the 3619 calls made by the participants, there were only 60 (1.65%) calls which suggested difficulty in connecting to the system and 51(1.40%) calls suggesting multiple attempts to get connected. The analysis of the clinical notes differentiated between the inability to connect to the system because the system was down (98 calls, 2.7%) and incidents where the patients themselves were having difficulty (82 calls, 2.2%). In addition to these technical difficulties, two other issues that affected adaptation emerged from the clinical notes. Firstly, 30 of the initial 79 SC+I participants (38%) did not have a set of functioning bathroom scales at the time of recruitment into the study. Secondly, six of the participants (7.6%) reported having difficulty using the phone due to a hearing impairment. Six questions within the acceptability survey referred to the "user friendliness" of the CHAT system. The overall rating of acceptability of these six questions was 82%.

3.3. Acceptability
Sixty participants (76%), completed the first year of the CHAT study, and were therefore eligible to complete the satisfaction questionnaire, which was administered by telephone within 2-3 weeks of completion of the 12 month study period. The total response rate for the survey was 90% (57 participants). These participants rated the CHAT service with a total acceptability rate of 76%. There were no significant demographic characteristics related to the satisfaction rates from this group. In addition to the calls registered within the CHAT system, a total of 1463 outgoing calls were made to the 79 (SC+I) participants by the CHAT nurses. The mean number of outgoing calls to a participant was 17.92 (SD±11.3, mode 18, range 3-61). Thematic analysis of the clinical notes revealed two broad themes and eleven sub themes in the CHAT nurse outgoing calls; these were heart failure management (73%) and technical failure and reminders to call-in (27%). Fig. 2 presents a more detailed break down of the outgoing calls.


Figure 02
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  		Fig. 2 CHAT nurse out-going calls theme analysis from clinical notes.

 
The positive aspects of the CHAT intervention that rated most highly (81%-86%) were: 1) the ease of getting connected; 2) understanding the pre-recorded questions and pressing the right buttons; 3) the time spent by the CHAT nurse and the confidence in the advice they offered. The Cronbach's Alpha reliability coefficient for this set of questions was 0.89 indicating reliability and internal consistency of the responses. Conversely, the most negatively perceived aspects of the intervention (50%-68%) were 1) helping to understand medicines and take medicines and 2) whether the participant thought that the CHAT nurse or GP was checking up on them.

Upon completion of the survey, participants were given the opportunity to make open ended comments about the service. Examples of "general comments" which reflect positive and negative feelings about the CHAT intervention and "critical incidents" reporting on significant events, in which the participant and the CHAT nurse interacted, are shown in Table 2.


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  		Table 2 Acceptance survey; examples of open ended comments about the CHAT service made by participants

 

   4. Discussion
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
5. Conclusion
 References
 
This study examined adherence; adaptation and acceptance to a telephone-monitoring system in a representative cohort of CHF patients participating in the CHAT study. Participants lived pre-dominately in rural and remote areas of Australia. Consistent with the demographics of chronic heart failure in Australia [28].

Using intention to treat analysis, the overall adherence to the CHAT study protocol was 62%. However, the group who completed the follow-up period had a much more committed adherence rate of 92% and this compares well to other telemonitoring studies such as de Lusignan [29] who reported 75% adherence to telemonitoring of weight and 90% adherence to blood pressure monitoring. The WHARF [30] telemonitoring trial reported 98.5% adherence and Capomolla [12] reported an adherence rate of 81% to telemonitoring. Although it would be preferable if overall adherence was higher, it is important to remember that telemonitoring adds other layer to the complex expectations of chronic heart failure self-care (e.g. managing medicines, diet, fluid, exercise and regular medical assessment). For most of the participants in our study, this was the first interaction with a specialist CHF management team and this may explain the enthusiasm of some (Table 2).

Forty percent of the participants who died during the trial period also showed good adherence to the protocol. Analysis of the clinical notes (including the comments of their carers) indicated that the CHAT service provided additional care and support (by telephone) at the end stage of this syndrome. This is an important issue, and highlights the fact that patients with NYHA class IV should be considered for CHF telephone support services.

Misconceptions of technophobia in the elderly were dispelled by the analysis of call patterns and clinical notes, which indicated that a very low number of participants (<3%) were unable to learn how to use the technology competently. We found that our elderly CHF participants were more than able to cope with this type of technological monitoring. However, some simply preferred not to add healthcare technology into their busy lives. (Table 2)

Two important factors regarding adaptation were also noted from the clinical records; the first was that one third of the participants did not have bathroom scales in their homes at the time of the initiation call. This finding questions the level of self monitoring prior to enrolment into the CHAT study. The second adaptation issue was that telemonitoring and structured telephone health support requires the ability to listen and hear important and complex instructions. Participants with diminishing hearing ability reported finding the system very hard to use. During the first 12 months there were many requests from participants to increase the volume of the pre-recorded interactive messages. In light of this, a test of telephone hearing ability should be conducted before entry into future trials. A recent telephone-monitoring study which lists hearing ability in the inclusion criteria demonstrates support for this proposal [31].

The satisfaction (acceptability) of those participants who completed the first 12 months of the study was 76%, which reflected an overall satisfaction with receiving health care via technology. The open ended responses and the critical incidents from the survey (Table 2) demonstrated the complexity of the lives of many of the participants who not only have CHF but other co-morbidities such as cancer. Also emerging from the clinical notes and the satisfaction survey was the amount of interaction the CHAT nurse had with family and supportive others. This wider effect of the intervention, beyond the participant, is also supported by data from Riegel et al. which also showed a considerable number of interactions with family [31].

These findings are consistent with other CHF telephone-monitoring studies such as the TEN-HMS study [14] where, overall patient acceptance was 91.2% (96% of patients were well satisfied with the system and 97% found the telecare devices easy to use) and the first 150 patients in the TeleWatch– service, who reported an overall system acceptance of 75.4%.[23]. In addition, a systematic review of patient satisfaction with telemedicine by Mair, [17] reported that most patients were satisfied with the improved accessibility to specialist care and decreased travelling (reducing travel to healthcare services was a very important issue for our rural patients).

There are, however, several limitations to our study. Data on primary outcomes in the CHAT study have yet to be published; therefore, these results are an interim analysis and should be considered in that context. On completion of the CHAT study, a larger sample size may give statistical significance and identify some of the key characteristics, including ethnicity as identified by Riegel [31], that may indicate which CHF patients are best suited to structured telephone support or telemonitoring. The recruitment process involved unblinded GPs selecting suitable participants according to the inclusion criteria. The potential importance of a highly selected, voluntary group of elders who may well represent the "techno-friendly" spectrum of CHF patients-leading to high levels of acceptance and uptake should also be taken into account. We would also strongly recommend more reporting of adherence, acceptability and adaptation in future trials, as these important secondary outcomes are currently under-reported in published large structured telephone and telemonitoring trails [32-34].


   5. Conclusion
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
 5. Conclusion
References
 
This study shows that elderly CHF patients can adapt quickly to telephone-monitoring, find its use an acceptable part of their healthcare routine, and are able to maintain good adherence for at least 12 months. These findings support the use of structured telephone support and telemonitoring as part of a comprehensive chronic heart failure management programme.


   Acknowledgements
 
Robyn Clark is a PhD Scholar supported by the National Institute of Clinical Studies (NICS) and the National Heart Foundation (NHF) of Australia.

The author wishes to acknowledge the work and support which has contributed to this paper from the CHAT Study teams both at the National Heart foundation Call Centre South Australia and the Department of Epidemiology and Preventive Medicine, Monash University.

The CHAT Investigators gratefully acknowledge the following funding sources: the National Health and Medical Research Council of Australia, the National Heart Foundation of Australia, Medical Benefits Fund of Australia, a Pfizer CVL Grant and My Chemist.

The CHAT Study Team would also like to acknowledge, Dr Edward Kasper and Dr Jeff Spaeder, Department of Cardiology and Mr James Palmer, Applied Physics Laboratory, John Hopkins University, Baltimore, Maryland, USA, for the use of the TeleWatch– telemedicine system along with ongoing expert advice and support of its usage.


   References
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
 5. Conclusion
 References
 

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J. G.F. Cleland, A. P. Coletta, A. Torabi, and A. L. Clark
Clinical trials update from the European Society of Cardiology heart failure meeting 2009: CHANCE, B-Convinced, CHAT, CIBIS-ELD, and Signal-HF
Eur J Heart Fail, August 1, 2009; 11(8): 802 - 805.
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