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  • SOC1: How adult patients with CHF (and their important others) who uses Structured telephone support (STS) react and act upon this technology and how this affects their satisfaction, quality of life, empowerment?
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How adult patients with CHF (and their important others) who uses Structured telephone support (STS) react and act upon this technology and how this affects their satisfaction, quality of life, empowerment?

Authors: Alessandra Lo Scalzo, Ingrid Wilbacher

Internal reviewers: Pseudo253 Pseudo253, Pseudo285 Pseudo285, Pseudo294 Pseudo294, Pseudo332 Pseudo332

Acknowledgments: Maja Boban

Among the secondary literature retrived and selected as relevant, we identified the HTA by Pandor et al. 2013 and the Cochrane Colaboration Systematc Review by Inglis et al. 2010 (which updated the previous systematic review by Clarck et al.) to answer to this research question. This gave a quantitative answer based on studies that used a measurament of quality of life with standardised instruments. We reported the results of those sythesis studies, and added the results of other relevant quantitative primary studies which were not included in those systematic reviews, due to time of publication or because of the qualitative nature of their study design. Futher a synthsis of the qualitative studies that were selected as provided a ”qualitative” answer to assessent elements was also provided.

 

Main results

Synthsis lit. (HTA)

 

Pandor et al. 2013

Four studies were on STS and 2 of them reported improvements in quality of life (Barth, 2001), (Wakefiled, 2008) measures in intervention group. One study found no significant differences between groups (Riegel, 2006). Angerman (2011) measured high adherence in inervention group.

Quantitative studies

 

Piotrowicz, 2015

  • Similar improvement in total QoL. Different in subscales: in intervention group had improvement in mental categories

Prescher, 2013

  • Higher self-care in the intervention group

Domingues, 2011

  • No difference between the two groups. Improved knowledge of HF and self-care in all patients regardless of telephone contact after discharge.

Ferrante, 2010

  • Some improvement in compliance and selfcare in intevention group

Brandon et al. 2009

  • Mean HRQOL had a positive significant change in intervention group. Self care ability impoved in intervention group.

Dunagan et al. 2005

  • Modest but significant change in physical dimensions at 6 months

Jearnt, 2003

  • Lack of difference between the two groups

Qualitative studies

 

Lynga 2012

Patients’ interviews analysis showed that:

  • Intervention was perceived easy to perform,
  • Made patients with HF active in their own care, and increased their self-care activities.
  • Patients perceived that they were safer and well cared
  • Concerns of potential deterioration in HF related to weight gain

Riley JP, 2013

Patients’ interviews analysis showed that:

  • Telemonitoring was integrated it into everyday routines easily.
  • Became more knowledgeable about their heart failure.
  • Relationship with the telemonitoring nurse perceived a way of having a  personalized and additional care.

Seto 2012 and 2010

Patients’ interviews analysis showed that :

  • Increased Self-Care
  • improved Knowledge of Heart Failure Condition
  • increased reassurance and a reduced Anxiety
  • Increased empowerment and confidence

HTA reports

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).

Primary studies

Quantitative studies

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 [12] 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)

 

In the Jerant et al. study 2003, patients were randomised into three groups: usual care, video based telecare and just telephone care with scheduled calls by a nurse. All groups experienced slight reduction in MLHFQ scores, indicating less emotional and physical burden due to CHF after the intervention. Similarly, SF-36 mental component scores increased slightly for all groups during the intervention, indicating slightly improved mental health status, and SF-36 physical component scores also increased slightly for the telecare and telephone groups, indicating somewhat improved physical health status. However, none of the differences between the groups at either baseline or 60 days and non of the within group pre- and post- intervention differences were statistically significant. No clinically meaningful or statistically significant changes in CSQ scores for any of the groups occurred as a result of the intervention. Authors highlight that their study was probably not of adequate power to detect small differences in health status or satisfaction scores. The lack of significant differences in MLHFQ, SF-26 and CSQ scores between groups suggests that telenursing at least did not have any large negative impact on patient satisfaction or health status. It is also possible that the existing instrument we used to measure satisfaction and health status are not sensitive enough to detect differences in these outcomes due to varying the communication medium by which home nursing care is delivered. For example, in contrast to the lack of significant differences in measured health status and patient satisfaction between groups, the study nurse and several subjects informally commented that home telecare resulted in a greater feeling of “collectedness” and security than standard telephone calls. Therefore, health status and patient satisfaction measurement tools to evaluate the impact of differing processes of providing home nursing care should be developed and validated.

Qualitative studies

In their qualitative study (which was the qualitative part of an RCT, involving six centres in Sweden by Lynga° et al., 2012. Authors developed a typology of the patients focussed on the different reactions to the telemonitoring system they could detect from interviews. Their aim was to describe how individuals in the group experienced and understood the TM. Patients in the intervention group were asked to weight themselves daily and measurements were automatically transmitted to an HF clinic. If a weight gain was detected the patients were contacted by telephone and asked questions based on the RCT study protocol. If there were signs of deterioration in the patients the dose of diuretics was temporally increased.

Authors interviewed 20 patients among the ones in the intervention group. The analysis of the interviews brought to identify five metaphoric categories of understanding the intervention.  

  • The habitual patient: this way of reacting contained perceptions that the transmission of BW and the daily weighting was easy to do and became a routine. The procedure was described as stressful because of concerns that they would forget to weigh themselves each morning; however, this was a temporary condition that transformed and turned into a routine.
  • The concerned patient: described concern in relation to the transmission of BW. One perception that was described was the fear to forget to carry out the daily activity of weighing oneself as well as assuming that they did something
  • The technical patient: patients had different experiences of the equipment. There were indications that when the system did not work as expected, the patients’ enthusiasm decreased and they got weary of using the electronic scale.
  • The secure patient: some patients felt to be looked after and a sense of security emerged. The patients had constant contact with the HF clinic and t healthcare professionals and was perceived as receiving good, being under a positive control
  • the self-caring patient: patients  described being active, wanting responsibility, and fully cooperating with the study nurses.

The authors conclude that the patients the intervention was easy to perform, made patients with HF active in their own care, and increased their self-care activities. Patients perceived that they were safe and well cared for and got a better understanding of their own bodies. However, there were concerns of potential deterioration in HF related to weight gain which should be considered in clinical care. However, there were concerns of potential deterioration in HF related to weight gain which should be considered in clinical care.

In the qualitative study by Riley JP et al 2013 authors aimed at exploring the extent to which telemonitoring in patients with heart failure empowers them to selfcare. Patients used a stand-alone telemonitoring system that required them to take measurements daily. They recorded physiological data using a weighing scale, automated blood pressure cuff and pulse oximeter. The telemonitoring equipment was connected to the normal home telephone line and the information was automatically transmitted to a secure base station for review by a cardiac trained nurse who triaged and responded to data indicative of clinical change. Riley interviews with 15 patients allowed mean age 74 to identify four key themes related to self-care: the experience of symptoms; use of the technology; heart failure self-care maintenance activities; and heart failure self-management. Patients in Riley’s study were old, with more than 50% aged over 75 years (and more than 33% aged over 80 years). According to Riley’s conclusions interviews showed that they used the telemonitoring daily and integrated it into their everyday routines easly, became more knowledgeable about their heart failure over the six month period of using telemonitoring but in this, according to Riley, what helped was the relationship with the telemonitoring nurse whom they perceived provided them with specific and personalized information. It emerged the importance of the relationship between the patient and telemonitoring nurse suggesting a possible role for telemonitoring in facilitating self-care but with the presence, also at the telephone, of a professional.

Two studies by Seto et al. published in 2010 and 2012, gave some insight on their patients’ attitudes toward phone-based telemonitorinhg (2010) and later on their actual perceptions a with it (2012). In the first study about attitudes (that is patients did not yet experience the intervention), the willingness to use a mobile phone-based remote monitoring was under evaluation. Patients as a whole seemed to be confident in their ability to Use Mobile Phone-Based Remote Monitoring and when, knew they were not accustomed to the technology,  stated that they would be able to receive help from family members (eg, their spouses and children).  The interviews indicated that patients were comfortable using mobile phones and computers, and were confident that they could learn to look up health information on both mobile phones and computers. Most patients perceived that monitoring their weight and blood pressure was important to help manage their heart failure condition. Several interviewed patients volunteered and said they would be willing to try using the proposed remote monitoring system.  Nontheless authors highlight that the remote monitoring system was acceptable under some conditions. Patients expressed their need to see it as something added to the relationship with their clinician at the heart function clinic, that is the system should not be a replacement of face to face interactions. More over patients would adhere to taking daily measurements long-term if they perceived clear tangible benefits and asked for the system to be as easy to use as possible and requested appropriate training and to get technical support if needed.

In the second study by Seto et al they interviewed patients after the actual use of the intervention. A perception of increased Self-Care emerged. The telemonitoring system enabled patients to appropriately modify their lifestyle behaviors (eg, salt and fluid restrictions, diuretic dose, and exercise). IT improved Awareness and Knowledge of Heart Failure Condition as Patients expressed becoming more aware of their heart failure condition and their own body, because they were taking their physiological measurements and symptoms daily. Patients expressed also feelings of an increased reassurance and a reduced substantial anxiety prior to using the telemonitoring system, especially those who were newly diagnosed or those who recently had an acute cardiac episode. Many patients referred to the telemonitoring system as a "security blanket" and it was "like almost having a doctor right beside you".  Increased empowerment and confidence and self-care motivation were also another factors that according to Seto et al. came out from interviews. Patients expressed feelings of more in control, confident, and accountable, because they could directly observe the effects of their lifestyle choices on their health and become active participants in their own health. Authors conclude that patients did not want remote monitoring to result in a decrease in communication with health care providers, and thought that they would continue remote monitoring only if there were clear andtangible benefits to their doing so.

Important
Partially
Lo Scalzo A, Wilbacher I Result Card SOC1 In: Lo Scalzo A, Wilbacher I Social aspects In: Jefferson T, Cerbo M, Vicari N [eds.]. Structured telephone support (STS) for adult patients with chronic heart failure [Core HTA], Agenas - Agenzia nazionale per i servizi sanitari regionali ; 2015. [cited 16 June 2021]. Available from: http://corehta.info/ViewCover.aspx?id=305