The HTA report by Pandor A, Thokala P, Gomersall T, et al. is the most recent and good quality secondary study we found as it was published in 2013 (searches of literature are until January 2012). This is about home telemonitoring or structured telephone support programs after recent discharge in patients with heart failure. The authors do not dedicate an ad hoc chapter to patients and families views on those technologies, but do consider quality of life as a secondary outcome in their review of clinical effectiveness (Chapter 3).
Pandor and collegues provide first a brief overview of the evidence from two already existing systematic reviews on remote monitoring programs (Inglis et al. 2008 and Klersy et al. 2009). The methodological quality of both systematic reviews is judged by Pandor to be high, this indicating low risk of bias. Pandor highlights that Klersy et al. did not consider quality of life and acceptability, while Inglis et al did. The latter identified all the studies published before 2008 by updating the previous Cochrane review on the same topic publishes by Clark et al. in 200. Inglis et al.’s review was published in 2010 and included RCTs comparing HF management strategies delivered via STS or TM with usual post-discharge care in HF patients recently discharged from an acute care setting to home or while managed in the community setting (interventions including home visits by professionals personnel for the purpose of education or clinical assessment were excluded) published form 1995 to December 2008. Secondary outcomes included also QoL, and acceptability to patients with HF. Overall, 30 RCTs of STS and TM were identified (25 peer-reviewed publications and five abstracts). Of the 25 peer-reviewed studies, 16 evaluated STS which is the technology of our interest.
Pandor et al. updated this review and their literature searches identified 3060 citations. Of these, 6 RCTs met the inclusion criteria and were added to the 15 trials from the previous systematic reviews. No trials of cardiovascular implanted monitoring devices or observational studies met the inclusion criteria of the current review. Of these, 11 studies evaluated our STS (10 used standard telephone equipment using and one provided support via an automated telephone interactive response system (HM) with an alert system, nine studies assessed TM, and one study assessed both STS and TM compared with usual care. Almost all of the studies used different measures and devices as part of the STS and TM interventions.
Pandor’s analysis highlights that quality of life was a secondary outcome measure in 8 of the 21 included studies. These were either a direct comparison between intervention and control groups at study conclusion or a comparison between baseline and study conclusion within the study arm. Since not all the studies included by Pandor were about STS, here after we will focus on describing just those studies that were on STS.
Among the above 8 studies which had quality of life as a secondary outcome, just 4 were on Structured Telephone Support. Three of them reported improvements in quality of life, with significant improvements in physical (p = 0.03) (Angermann, 2011) and overall (MLHFQ, p 0.001) (Barth, 2001), (Wakefiled, 2008) measures. One study found no significant differences between groups in either the MLHFQ or the EQ-5D measure (Riegel, 2006). Pandor’s focuses also on the acceptability”and “patient satisfaction” for the systems and only 1 of the 4 studies about STS reported adherence (compliance) rates to the intervention (Angermann, 2011). Adherence was measured at 84.0% for STS by Angermann, 2011.
A range of psychometric measures were used including both generic and HF-specific measures:
- SF-36, 51 (Angermann, 2011).
- Minnesota Living with Heart Failure Questionnaire (MLHFQ) 72 (Barth, 2001), (Wakefiled, 2008).
- European Quality of Life-5 Dimensions (EQ-5D). (Riegel., 2006).
In our search we identified and selected 9 further studies that can add some information about quality of life with STS in our population, which were either published after January 2012 (Piotrowitz 2015; O’Neil, 2014; Prescher, 2013; Domigues, 2012) or were published before that date but were not retrived or included in Pandor’s HTA (Seto 2010, Ferrante, 2010, Brandon 2009; Ramachadran, 2007 Dunagan, 2005; Jerant, 2003). A description of the main results about quality of life of those studies is reported below.
The prospective randomized controlled trial by Piotrowicz et al 2015 had as intervention the home-based telemonitored cardiac rehabilitation system while comparator was outpatient-based standard cardiac rehabilitation. It involved 131 patients: 56 were in standard care, while 75 had home-based telemonitored cardiac rehabilitation (HTCR). Satisfaction was measured via the Polish version of the Medical Outcome Survey Short Form 36 (SF-36) questionnaire. The vast majority of patients in both groups were satisfied with the support which they received during each training session. According to author this demonstrated that in heart failure patients HTCR provided a similar improvement in total QoL index as standard care (SCR). Yet it differed in QoL subscales. Patients who underwent home-based tele rehabilitation observed an improvement mainly in the mental categories. Patients in SCR Group improved their general physical well-being. There were no statistically significant differences between the groups regarding the improvement in total QoL index, PCS (physical component summary ) score (PF- physical function, RP- role limitation caused by physical problems, BP- bodily pain) or MCS (mental component summary ) score (MH- mental health, RE- role limitation caused by emotional problems, VT- vitality). Groups differed in terms of sense of GH (general health) and SF (social function). An improvement in SF (social function) was observed only in standard care Group. Both groups achieved significant improvement in total QoL index, PCS (physical component summary) score, MCS (mental component summary) score. In the subscales evaluating physical well-being, in SCR Group, improvement was observed in three (PF physical function, RP physical problems, BP bodily pain) out of four subscales. In comparison with the baseline examination findings, patients after trainings reported fewer PF restrains, found it less difficult to function socially because of better physical fitness and complained less of BP. HTCR patients improved in PCS in only one out of four subscales. They perceived their PF as better after rehabilitation. The other subscales (RP, BP, GH) did not change significantly. In the subscales assessing mental well-being, in SCR Group, an improvement was observed in three (SF mental health (MH), role limitation caused by emotional problems (RE), vitality (VT) out of four subscales. The results showed that SCR patients reported fewer limitations in their social functioning; moreover they had a better sense of mental health and vitality after rehabilitation completion. HTCR patients improved in MCS in two (MH, VT) out of four subscales after the rehabilitation cycle was completed. The role limitation caused by physical problems did not change significantly in both groups. There were no statistically significant differences between the groups regarding the improvement in total QoL index, PCS score (PF, RP, BP) or MCS score (MH, RE, VT). Groups differed in terms of sense of GH and SF. An improvement in SF was observed only in SCR Group. Cardiac rehabilitation did not have a significant effect on the sense of GH in both groups. The difference between the groups in the analysis is due to the fact that in terms of this parameter the groups differed before the beginning of the rehabilitation.
The study by Prescher et al 2013 has an observational design and does not have any control arm. Patients (n=710) underwent the Telemedical Interventional Monitoring in Heart Failure (TIM-HF). Of them 228 patients originally included answered a quality of life questionnaire (author do not explicit which kind of questionnaire was used). Of the surveyed patients, the 85,5% (n=195) declared to feel more confident in dealing with their disease than before. The additional information about their disease was considered as reasonable by the patients (86,6%; n=198). In the supplementary notes the patients emphasized that the program had given them safety and support in handling their chronic disease (n=17), especially by the monitoring and the contemporary feedback by the telemedical centers of their transmitted vital parameters. The daily 24h/7d accessability of the telemedical center was reported as important by the patients (84,6%, n=193). Only 5,7% (n=13) rated this opportunity as unimportant and 9,7% (n=22) rated this as neutral or did not answer this question.
The brasilian study by Domingues et al, 2011 is a randomized clinical trial. They study adult HF patients with left ventricle ejection fraction who could be contacted by telephone after discharge. Authors evaluated HF awareness through a standardized questionnaire which also included questions regarding self-care knowledge, which was answered during the hospitalization period and three months later. The HF patients were 120 of them just 58 had a telephone contact and were randomised in the Intervention group. The others became automatically the controls. For patients in the IG group contacts were made using phone calls and final interviews were conducted in both groups at end of the study. Forty-eight patients were assigned to the IG and 63 to the CG. Mean age (63 ± 13 years). Scores for HF and self-care knowledge were similar at baseline. Three months later, both groups showed significantly improved HF awareness and self-care knowledge scores (P<0.001). Other outcomes were similar. According to Domingues et al, results show that the educational nursing intervention performed during the hospitalization period brought about improved knowledge of HF and self-care in all patients, regardless of any telephone contact after their discharge from the hospital. There was no difference in the frequency of visits to the emergency room, rehospitalizations and deaths in the three-month period between the intervention and control groups.
Ferrante et al. 2010 is a follow up study of the DIAL study (Grancelli, et al. 2003) which aimed to monitor the long term results after a telephone intervention in HF pateints, some data can be found aboput compliance with therapy and if this increases after STS. In the original study (DIAL) patients had been assigned to the intervention group received an explanatory booklet at randomization and were followed up with a telephone intervention by specialized nurses. The objectives of the intervention were to improve diet and treatment compliance, to promote exercise, to regularly monitor symptoms, weight, and edema, and to promote early visits if signs of clinical deterioration were detected. Nurses could adjust diuretic dose and suggest unscheduled visits to the attending cardiologist. Patients were initially called every 14 days, and after the fourth call, the frequency could be adjusted according to the severity of each case and patient compliance. Subjects in the control group continued treatment with their cardiologist in the same manner as the intervention group, except for the phone calls and the explanatory. In Ferrante et al 2010, of 760 patients in the intervention group, 69(9.1%) did not improve compliance during the first 45 days, 296 (38.9%) improved only in 1 indicator (diet, weight control, or medication), 277 (36.4%) improved 2 indicators, and 118 (15.5%) improved in all 3 indicators. Overall, 82.8% improved in medication compliance, 40.7% improved in diet compliance, and 34.9% improved in daily weight control. Considering the primary end point after 3 years of follow-up, the cumulative incidence in the control group was 57.5% (n _ 436), 65.2% (n _ 45) in the intervention groups with no improvement in compliance, 57.4% (n _170) in the intervention group with improvement in indicator, 52.3% (n _ 145) in the intervention group with improvement in 2 indicators, and 53.4% (n _ 63) in the intervention group with improvement in all 3 compliance indicators (log-rank test p _ 0.041). Differences were more significant when admission for HF was considered as an end point: control group, 35.1%; intervention without improvement, 33.3%; with 1 indicator, 33.1%; with 2indicators, 27.1%; and with all 3 indicators, 17.8% (log-ranktest p _ 0.0009) . These differences persisted after being adjusted by other potential confounders in the Coxregression analyses (sex, age, New York Heart Association functional class, diabetes mellitus, previous admissions,chronic obstructive pulmonary disease, systolic dysfunction):the HR for the intervention group categorized by compliance versus the control group for HF admission according to compliance improvement were as follows: no improvement, HR: 0.91 (95% CI: 0.59 to 1.40, p _ 0.67); 1 indicator improvement, HR: 0.87 (95% CI: 0.69 to 1.10,p _ 0.25); 2 indicators improvement, HR: 0.71 (95% CI:0.55 to 0.92, p _ 0.012); and 3 indicators improvement,HR: 0.44 (95% CI: 0.28 to 0.69, p _ 0.001)..
Brandon et al study (2009) has a pretest–posttest experimental design in which participants were randomly assigned to either an experimental group, who would receive the APN (advanced practice nurses) led telephone intervention, or a control group, who would receive the usual care provided by their cardiologist. the results for the advanced practice nurses intervention on self-care behaviors revealed a significant interaction (p b .001), indicating that the intervention group improved significantly more than the control group. There was an improvement in the mean self-care behaviour scores for the intervention group whereas the control group’s mean score did not change. The intervention group reported more improvement in overall Quality of Life, and the control group reported a decrease. The mean pretest score for total QoL for the intervention group was 52.1 and their posttest score for total QoL was 33.4, indicating an improvement in perceived QoL overall. The control group's pretest score for total QoL was a mean of 51.1 and the posttest score for total QoL was a mean of 57.7, suggesting a decrease in perceived QoL overall.. The results of the physical and emotional dimension score revealed no statistical signification between the groups, but with a slight trend for better values of the physical dimension for the intervention group. For the emotional dimension both groups reported significant improvement over time. Authors highlight that an interesting factor was that, among all participants, QoL was consistently poor for those ranked at Level III on the NYHA HF classification, and the Class III HF participants were the only participants in the intervention group who did not report an improvement in QOL upon posttesting (NYHA level IV has only 1 participant so this level could not be evaluated). The self-care ability improved from a relatively good level of 65% to a higher level of 88% in the intervention group.
The prospective, randomized clinical trial by Ramachandran et al, 2007 recruited 50 consecutive patients with heart failure in a clinic in India to assess the impact of a comprehensive telephone-based disease management programme on quality-of-life in patients with heart failure. The HRQOL was evaluated both subjectively and objectively at the end of the 6-month period (mean [SD]: 188  days). It was assessed subjectively by scoring the KCCQ (Kansas City Cardiomyopathy Questionnaire), physical examination and NYHA class. Objective assessment was done by the 6-minute walk test. There was no significant change in the mean HRQOL score of the control group during the study period (62.2 [22.6] to 63.4 [21.9]; p=0.69). However, there was a significant change in the intervention group (60.0 [23.6] to 76.3 [17.3]; p<0.05, see (Fig. 2 from the study by Ramachandran et al, 2007). A part of the questionnaire assessed the patient's ability to carry out activities of daily living and strenuous activities. While there was no significant change in the control group (p=0.9), there was a significant change in the intervention group (baseline score 53.9 [21.3] v. follow up score63.3 [16.2]; p<0.05;). The symptom scores (assessing the frequency and severity of symptoms of heart failure) also showed a significant change in the intervention group (p<0.05) but no change in the control group. The difference in scores between the intervention and control groups at follow up was also significant (p=0.02). Another part of the questionnaire assessed the presence and degree of depression, and the interference caused by the disease in the social functioning of the patient. The control group showed no significant change (p=0.66) but the intervention group did (baseline score 49.3 [22.8] v.follow up score 64.5 [18.9];p<0.05). There was a significant difference in the scores of the two groups at follow up (p=0.001).See Table IV from the study by Ramachandran et al, 2007. Six-minute walk test. There was a difference in the results in the intervention group (p<0.02) but not in the control group (p=0.5).
Dunagan et al. 2005 RCT was performed in USA. Authors show that there were modest but statistically significant changes in physical functioning scores on both the SF-12 and the MLHF questionnaire at 6 months, but not at 12 months. Changes in scores for the SF-12 mental functioning scale, MLHFQ emotional health subscale, and BDI were not significantly different at 6 or 12 months. There were no significant differences between the groups in terms of changes in scores for any of the questions concerning patient satisfaction with care or confidence in their knowledge of and ability to manage their illness. They found that nurse-administered, telephone-based disease management intervention that included judicious use of “rescue” diuretic therapy and patient education about signs and symptoms of HF and self-monitoring, had minimal impact on changes in measures of functional status and quality of life.
(results continue in the "comment" section)