Showing posts with label HCV Self-management. Show all posts
Showing posts with label HCV Self-management. Show all posts

Friday, June 17, 2011

The Hepatitis C Self-management Programme

From Journal of Viral Hepatitis

The Hepatitis C Self-management Programme

E. J. Groessl; K. R. Weingart; C. J. Stepnowsky; A. L. Gifford; S. M. Asch; S. B. Ho
Posted: 06/16/2011; J Viral Hepat. 2011;18(5):358-368. © 2011 Blackwell Publishing

Chronic hepatitis C (HCV) infection afflicts millions of people worldwide. While antiviral treatments are effective for some patients, many either cannot or choose not to receive antiviral treatment. Education about behavioural changes like alcohol avoidance and symptom management, in contrast, is universally recommended, particularly in HCV-infected persons from disadvantaged groups where liver risk factors are most prevalent. Self-management interventions are one option for fostering improved HCV knowledge and health-related quality of life (HRQOL). One hundred and thirty-two patients with VA with HCV (mean age of 54.6, 95% men, 41% ethnic minority, 83% unmarried, 72% unemployed/disabled, 48% homeless in last 5 years) were randomized to either a 6-week self-management workshop or an information-only intervention. The weekly 2-h self-management sessions were based on cognitive-behavioural principles and were adapted from an existing self-management programme that has been efficacious with other chronic diseases. HCV-specific modules were added. Outcomes including HRQOL, HCV knowledge, self-efficacy, depression, energy and health distress were measured at baseline and 6 weeks later. Data were analysed using ANOVA. When compared to the information-only group, participants attending the self-management workshop improved more on HCV knowledge (P < 0.001), HCV self-efficacy (P = 0.011), and SF-36 energy/vitality (P = 0.040). Similar trends were found for SF-36 physical functioning (P = 0.055) and health distress (P = 0.055). Attending the self-management programme improved disease knowledge and HRQOL 6 weeks later in this disadvantaged population. The intervention can improve the health of people with hepatitis C, independent of antiviral therapy. Future research will study longer-term outcomes, effects on antiviral treatment and costs.


Hepatitis C virus (HCV) infects about 1.8% of the US population[1] and often co-occurs with substance abuse problems, homelessness and impoverishment.[2–5] Long-term medical consequences of HCV include cirrhosis, hepatocellular carcinoma[6] and/or the need for liver transplant.[7] In addition, most HCV-infected individuals experience a variety of physical and psychological symptoms, functional limitations and impaired quality of life as a result of having HCV and co-existing chronic health problems.[8,9]

Treatment with antiviral medications eliminates the virus in many patients,[10,11] but lower success rates have been found outside of clinical trials.[12] Nevertheless, the vast majority of patients are either ineligible for treatment, refuse treatment, fail treatment, or treated with watchful waiting.[13] In fact, it is estimated that only about 20% of patients with VA with HCV have ever initiated antiviral treatment.[12] Common reasons for not receiving treatment are ongoing substance abuse, psychiatric disorders[12] and poor attendance of clinic appointments. Thus, despite ongoing improvements in antiviral treatments, there are few treatment alternatives for people with HCV.

Treatment recommendations for HCV-infected patients often include attending regular follow-up visits, obtaining additional laboratory tests, undergoing psychiatric evaluation,[14] abstention from alcohol,[15,16] avoiding transmission of the virus, avoiding certain foods or medications, exercise/losing weight[17–20] and making decisions concerning antiviral treatment.[21] Yet, many patients may not have the information or skills required to adhere to these recommendations successfully.[8]

As with other chronic illnesses, there are social, behavioural, and cognitive skills that patients can use to participate more effectively in the management of their HCV. These self-management strategies can help patients manage their symptoms, increase their functionality, make more informed decisions about treatment and potentially help prevent them from spreading the virus to others. Despite the need for such approaches, little or no research on self-management for hepatitis C has been undertaken.

Self-management interventions go beyond traditional patient education in that they are more comprehensive, focus more on facilitating change, teach problem-solving skills instead of primarily disseminating information[22] and engage the patient in the day-to-day management of his/her illness. Self-management programmes are primarily grounded in social cognitive learning theory.[23,24] Social learning theory emphasizes several dimensions along which change can occur, such as increasing self-efficacy and motivation, learning-specific illness management information and skills, enlisting support from a social network and monitoring symptoms and emotions.[25] Good self-management programmes typically address (i) disease management, medications, general health; (ii) role management and (iii) emotional management.[26] Patients learn to identify and prioritize their own problems, take appropriate action and enlist the support needed to solve these problems in collaboration with healthcare professionals and family.

The purpose of this study was to examine the effects of a hepatitis C self-management intervention on the quality of life of HCV-infected individuals who are not currently on or scheduled to start antiviral treatment.


Study Design
The study was a randomized controlled trial comparing the effects of the hepatitis C self-management programme to an HCV information-only intervention among VA patients with chronic hepatitis C. A total of 137 patients were recruited and randomized to one of the two intervention groups. After obtaining informed consent and a release of medical information, patients were randomized to one of two interventions and completed a baseline assessment. Self-management or comparison interventions were delivered over a 6-week period. Follow-up assessments occurred 6 weeks after the baseline assessment. The study was conducted at the VA San Diego Healthcare System, San Diego, CA, USA. Inclusion criteria were: (i) a confirmed diagnosis of chronic hepatitis C; (ii) US military veterans age 18 or older; (iii) eligible to receive care at the VA San Diego Healthcare System; (d) willing and able to attend six weekly programme sessions lasting about 2.5 h each. Exclusion criteria were: (i) ongoing antiviral treatment for hepatitis C or scheduled to start antiviral treatment within 6 months; (ii) residence in a geographical area outside of San Diego County (intervention attendance is too difficult); (iii) ongoing treatment for another life-threatening co-morbid illness; (iv) fatal co-morbidity (life expectancy <6 months indicated by treating physician).

Recruitment and Retention

A multi-faceted recruitment approach was used. The approach was designed to reach a full spectrum of HCV-infected individuals, especially those who were impoverished and/or homeless, and often have been underrepresented in research. Patients were also told about the study by healthcare providers in the Hepatitis C Clinic and in primary care units at the VA San Diego Healthcare System. Flyers were posted in the Hepatitis C clinic, primary care clinics, the alcohol and drug treatment programme (ADTP) clinic, psychiatry and psychology clinics, common areas of the main VA hospital in San Diego, and at VA satellite clinics. Study recruiters also visited and established contacts at local recovery homes, homeless shelters, VA Stand Down San Diego and nonprofit organizations that serve veterans, such as St. Vincent De Paul and Veterans Village of San Diego (VVSD).

To minimize attrition and attendance problems, frequent contact with participants was maintained via phone and mail. The recruitment timeline for each cohort was approximately 1–2 months, so it was imperative to keep current phone numbers and addresses for interested persons. Prospective participants without working phone numbers were asked to contact study staff biweekly for study updates. After the initial baseline assessment, participants were given a printed schedule with the dates of their remaining assessments and/or self-management sessions.

Assignment and Masking
As directed by referrals and flyers, potential participants called research project staff for more information on the study and eligibility screening. Participants who met study inclusion/exclusion criteria were added to a list of those interested in the study. Once a cohort of 20–25 participants had expressed interest, patients were randomized to one of the two interventions. Patients were recruited in nine cohorts over the course of 14 months. Research staff completed randomization for each participant using a computer-generated random number generator.[27] Blinding of participants and interventionists was not possible but both conditions could reasonably expect some improvement in outcomes. Intervention staff were not blinded, but all assessments were self-report questionnaires.

In an effort to standardize the amount of HCV-specific information available to participants and create a meaningful intervention for participants in the comparison group, both interventions were provided with an HCV-specific information packet upon completion of their baseline assessment. The packet contained information that is available to all patients with VA nationally through their healthcare providers and/or via the Internet and the Hepatitis C Resource Centers. In addition, all participants received a patient resource guide, containing an indexed list of health-related organizations and telephone numbers. Clinical care for chronic HCV infection continued as usual for participants in both interventions

.HCV Information Only

The HCV-specific information booklet consisted of printed materials that are currently available in the Hepatitis C Clinic and in other usual care clinics for patients with Hepatitis C. The materials included brochures and handouts titled 'Overview of Hepatitis C', 'Understanding the Side Effects of Interferon Therapy', Coping with Hepatitis C: Diet and Nutrition' and 'Talking with Others About Hepatitis C' to name a few. In general, the materials described hepatitis C and cover the topics of preventing the transmission of hepatitis C, avoiding certain foods and medications, discussing one's diagnosis with others, antiviral treatment and general behavioural recommendations. Also, included were printouts of the same presentation used for the self-management workshop intervention. The presentation was prepared and disseminated by the VA National Hepatitis C Resource Centers. Patients in the information-only intervention were able to ask their healthcare providers about the information they received at any time. Questions specific to the research study were directed to the project coordinator.

Hepatitis C Self-management Programme

Programme Development
The programme was adapted for veterans with chronic HCV infection from the chronic disease self-management programme (CDSMP) developed by Lorig et al. [28] The adaptation and development of the HCV-SMP were informed by a qualitative pilot study with HCV-infected veterans,[8] scientific literature, CDSMP training sessions at Stanford University and input from collaborators at the VA Hepatitis C Resource Centers and the VA HIV/Hepatitis QUERI Coordinating Center. Our main modifications to the CDSMP include the addition of three HCV-specific education modules developed by the VA National Hepatitis C Resource Centers, each about 20 min in length, a panel discussion with patients who had already completed antiviral treatment, treatment decision-making, discussion of substance use disorders and treatment, and increased time devoted to psychological issues, evaluating alternative treatments and communication with healthcare providers. To keep the intervention to a maximum of six sessions similar to the CDSMP, modules on advanced directives and cognitive distraction were removed and other modules were shortened.

The hepatitis C self-management programme (HCV-SMP) is designed to provide HCV-infected people with the knowledge and skills they need to improve their current and future health and health-related quality of life (HRQOL). The programme is based primarily on cognitive-behavioural principles and is multi-faceted, focusing not only on hepatitis C, but also on general health improvement. The programme incorporates a client-centred, empowerment-based approach that allows the participants to prioritize which elements of the programme that they would like to focus on most.

The HCV-SMP consists of six weekly workshop sessions that are 2–2.5 h in length. The sessions consist of a variety of group activities, including disease-specific information dissemination, problem solving, development of action plans, and re-evaluation and revision of action plans. Action plans consist of small behavioural changes that each participant aims to accomplish during the week between sessions. Participants report back on their success and are assisted with problem solving when they are not successful. In addition to the interaction and the exchange of social support that takes place between participants before and after the sessions, a 20-min break occurs at the middle of each session, and often encourages additional interactions among participants. Patients are encouraged, but not required, to discuss their experiences and problems with other group members and with the group as a whole. All programme activities are modeled for patients by the group leaders, and participants can opt out of activities at any time. In addition to the HCV information packet and the patients' resources guide, each patient attending the HCV-SMP receives a copy of the book Living a Healthy Life with Chronic Conditions[29] and a cassette tape or CD containing two relaxation exercises. Light refreshments were served at each session because the sessions are up to 2.5 h long, and fatigue can be a problem for patients with hepatitis C.

The HCV-SMP was co-led by a health professional and a peer-leader. Research has shown that peer-leaders can teach self-management as well as health professionals when properly trained and that patients may obtain additional benefit from being able to identify with someone who has the same illness.[30–32] To maintain consistency and fidelity of the multiple intervention cohorts, all workshops were delivered by the same leader and peer leader.

Between each workshop session, participants were contacted by the group leader via phone. The phone call is aimed to check on the progress of the participant's action plan and remind them of the upcoming group. After the first workshop session, participants are given the option to call each other once during the week instead of being called by the leader. Based on data from preliminary studies, participants look forward to the phone call, but many prefer to be called by the group leader.

The primary outcomes for the study were generic and disease-specific HRQOL. It was hypothesized that self-management participants would have greater improvements in HRQOL than information-only participants. Secondary outcomes were examined with the same hypothesis as the primary outcomes. These measures included HCV-related knowledge, self-efficacy, depression, energy/fatigue, alcohol use and health distress. A sociodemographic questionnaire was used to assess variables such as age, gender, race/ethnicity, education level, marital status, employment status, transportation and living situation.

Generic Health-related Quality of Life
The SF-36 and the quality of well-being scale–self-administered (QWB-SA) were used to assess generic HRQOL. The SF-36 is a generic, descriptive measure of HRQOL that includes eight domains: physical functioning, role limitations – physical, bodily pain, general health perceptions, vitality, social functioning, role limitations – emotional, and overall mental health.[33] The measure has well-established norms, and the reliability and validity of the SF-36 are well documented.[34–36] The QWB-SA is a preference-based measure that produces a single total summary score that is appropriate for cost-effectiveness analysis.[37–42] The QWB-SA also asks respondents to rate their global health over the past 12 months using a visual analogue type rating scale (VAS), anchored at 0 and 100.

Hepatitis C-specific Quality of Life
The hepatitis quality of life questionnaire (HQLQ) is a hepatitis-specific quality of life measure administered in conjunction with the SF-36. Domains assessed include physical and social functional limitations, health distress, sleep and vitality/energy. It was validated in HCV-infected individuals[43] and has been used in a number of HCV clinical trials.[44–46]

Hepatitis C Knowledge
HCV knowledge was assessed using a measure developed by the study investigators to assess topics covered in the VA National Hepatitis C Resource Center presentation that is available to all veterans via the Internet or through their healthcare providers. The measure consists of 15 questions with Yes/No/Not Sure response options.

Confidence in the ability to perform HCV-related self-management activities was measured using HCV-specific self-efficacy questions adapted from other studies.[47]

Energy/Fatigue was measured using a five-item scale adapted from the medical outcomes study.[47] The five items ask about how often symptoms of fatigue are present on average during the past month.

Depression was assessed using the Center for Epidemiologic Studies Short Depression Scale (CES-D 10).[48] A score of 10 or greater is considered depressed. Normative data from assorted chronic illnesses are available.[32]

Health Distress
Health distress health-related anxiety is a common symptom in people with a chronic, potentially life-threatening illness. Health distress was measured with a four-item scale.[47] 

Alcohol Usage
The Alcohol Usage Disorders Identification Test (AUDIT) was used to measure alcohol usage.[49] The measure is 10 questions and can be completed in 1–2 min. It is well validated and has been used extensively for many years.[49–52]

Statistical Analyses
Means and proportions of demographic and clinical characteristics for each group were compared with independent sample t-tests and chi-square analyses. Continuous variables were checked for violations of normality prior to t-test analysis. Equal variances were not assumed for the t-tests. Intention-to-treat analyses included repeated measures ANOVA and ANCOVA, which were used to compare differences between the two groups from baseline to the 6-week follow-up. Age and self-reported history of homelessness in the past 5 years were tested as covariates in the repeated measures ANOVA analyses. The covariates were retained in the model when significant at P < 0.05 level.
Based on previous studies of self-management programmes,[53,54] the study was powered to have an 80% chance, with alpha of 0.05, of detecting a medium effect size of 0.25, and required 64 subjects per group or 128 total subjects after attrition.

Figure 1 shows the identification, enrolment and randomization of patients in the study. Of the 372 individuals who expressed interest in the study, 81 were ineligible because they were currently on, had successfully completed, or were scheduled to start antiviral treatment in the next 6 months (n = 32), were not eligible for VA healthcare (n = 20), their HCV could not be confirmed (n = 21), or had previously participated in the self-management pilot intervention (n = 8). An additional 154 individuals were initially eligible but declined enrolment when it became available. All 137 participants were recruited and consented between May 2007 and November 2008. Confirmation of HCV infection could not be produced from any source for two people, who were subsequently unenrolled. One other patient withdrew from the study and analysis. Of the remaining 134 participants, two information-only participants did not complete the 6-week follow-up assessment, leaving data on 132 participants for analysis.

Figure 1.
Recruitment, randomization and retention flowchart.

Recruitment, randomization and retention flowchart.

Overall, the 132 participants had a mean age of 54.6, and 95% were men. Non-Hispanic white race/ethnicity was self-reported by 59% of the sample, with African Americans (24%) and Hispanics (10%) representing the next largest groups. The overall participant sample was 79% divorced, separated, or never married, 72% were disabled or unemployed, 35% never attended college, 68% relied on public transport or other people for transportation, 14% were homeless while another 36% lived in group living situations or with relatives, and 48% of the sample reported being homeless at some point in the last 5 years. The mean self-report year of contracting HCV was 1983, while mean self-report year of being diagnosed with HCV was 1997.

The two experimental groups were compared on three continuous and eight categorical variables. On average, participants in the information-only group were significantly older (t (1,130) = 3.07, P = 0.003) and more likely to be homeless in the past 5 years when compared with those randomized to the self-management programme. However, there was no difference between the two groups in the proportion that were currently homeless (See Table 1). Thus, age and self-reported history of homelessness were tested as covariates in the repeated measures ANOVA analyses. The covariates were retained in the model when significant at P < 0.05 level.

Participants randomized to HCV-SMP attended an average of 5.2 of six sessions (87%). As shown in Table 2, participants in the self-management group had better outcomes that were statistically significant at P < 0.05 on a number of important variables. SF-36 energy/vitality scores increased almost 5 points in the self-management workshop while the mean scores in the information-only group decreased 2.6 points (P = 0.040). Statistically significant differences over time were also found for HCV knowledge (F(1,129) = 20.35, P < 0.001) and HCV-related self-efficacy (F(1,130) = 6.57, P = 0.011). Trends towards greater improvements for HCV-SMP participants were found for SF-36 physical functioning, SF-36 bodily pain, health distress, depression and VAS global health. Overall, self-management workshop participants had greater improvements on 18 of the 22 variables.

Antiviral medication can eliminate HCV for some infected patients, but depending on patient and viral characteristics and treatment compliance, viral clearance for some patient subgroups is very low.[12] Furthermore, patients are very often either ineligible for treatment, refuse treatment, or are offered watchful waiting.[13] Substantial improvements in treatment success rates are expected over the next couple of years,[55] but there is a need for programmes that can help patients improve HRQOL while preparing them to become treatment candidates, and increasing their chances for achieving an SVR if they are eventually treated. Despite the need for such approaches, there has been little or no research conducted with self-management programmes for patients with hepatitis C. The randomized, controlled trial described here assesses the efficacy of the hepatitis C self-management programme for improving the HRQOL and other outcomes for patients with VA living with chronic hepatitis C.

The HCV self-management programme was well attended and produced significant improvements along a number of dimensions of HRQOL and other outcomes. Improving health-related knowledge is a main goal of most self-management programmes. While increased knowledge may improve healthcare satisfaction in consumers, it is not always considered sufficient for producing changes in other health outcomes. Improved self-efficacy (confidence in one's own ability to manage one's health condition) has been conceptually linked to changes in health outcomes in the social cognitive model on which the HCV self-management programme is based.[23,24,56] Self-efficacy is thought to interact with outcome expectations and sociostructural factors in the setting of goals and performance of behaviours. Behaviours in turn affect health outcomes, but it is also hypothesized that improved self-efficacy alone can improve quality of life, by reducing anxiety or distress associated with having a chronic disease and reducing powerlessness.[57]

The finding that the HCV self-management intervention improved scores on the energy/vitality subscale of the SF-36 is important. Fatigue is the most commonly reported symptoms of chronic HCV infection.[58,59] Fatigue has also been implicated as one of the symptoms most likely to impact other aspects of HRQOL, such as physical, occupational and/or social functioning.

Six other outcomes showed trends towards benefit from the HCV self-management intervention. Although we ran 22 separate statistical analyses, only one outcome would be expected to be significant by chance at the P < 0.05 level and 2 at a P < 0.10 level. Thus, there is fairly strong evidence that the intervention produced significant benefit for participants, but the study may have been underpowered to detect other effects not found to be significant. Given our final sample for these analyses, the study was powered to detect medium F-test effects (0.25) 81% of the time. Some of the effects were smaller than 0.25, but approached clinical significance. For example, a difference of 0.030 is considered clinically significant for the QWB-SA,[60] and our study produced group differences of 0.028 after just 6 weeks. Thus, our study may have benefitted from a larger sample size.

Effect sizes in the range of 0.20–0.25 and adjusted mean differences between groups for the SF-36 fatigue and physical functioning subscales of 6.7 and 6.9 respectively are similar to those found in other studies of chronic disease self-management programmes.[32,61,62] Other self-management studies have found differences on other outcome measures such pain, disability, etc., but found no differences on validated measures of HRQOL.[63–65] In fact, most self-management studies do not formally measure HRQOL at all.[66] This literature suggests that although the differences we have found are not large, they are meaningful, and it is important to start measuring self-management outcomes with widely used HRQOL measures such as the SF-36.
Chronic disease self-management interventions have also impacted other outcomes such as reduced health care utilization and increased health behaviours.[54,67] Our intervention was not designed to reduce health care costs and encourages HCV-infected patients to be properly evaluated for antiviral treatment which can be costly. However, if participants in the self-management programme are more likely to go on to be treated, there are well-established health benefits for those that achieve an SVR. Rates of antiviral treatment and response to treatment will be forthcoming. In addition, we plan to examine the costs of conducting the self-management intervention and conduct cost-effectiveness analyses. In general, we expect that the per person cost of the intervention will be low, because the intervention is delivered in group format for 6 weeks using existing facilities with few materials required. The cost analysis of a similar 6-week self-management programme found the intervention cost approximately £101 per person.[68]

Although not all outcomes improved significantly, the results are notable for a few important reasons. First, the project was successful in recruiting and retaining vulnerable veterans with few resources who have faced many life challenges, such as those with a history of substance use, homelessness and psychological disorders. Overall, participants appear to be representative of HCV-infected individuals in VA care and in the general community.[12] Thus, the intervention may be beneficial to a large majority of HCV-infected individuals, but should be studied for efficacy among nonveterans.

Second, the current results were achieved between baseline and a 6-week follow-up. Although some variables are expected to change the most directly between pre and post intervention, HRQOL outcomes combine many factors and can be hard to change in the short term with behavioural and cognitively oriented interventions. Often, behavioural interventions must be sustained for a longer period of time to achieve significant changes.[69,70]

One important unanswered question considers how many HCV-infected individuals will actually attend a 6-week self-management programme. This is difficult to determine because this is the first Hepatitis C self-management programme that has been developed. However, only 34 of 373 individuals who contacted study staff to inquire about the project declined because they did not want to attend. Many others expressed interest but could not attend at the time offered. A study of an asthma self-management programme examined the 'reach' of their programme and found that 474 of the 1303 in the target population with asthma actually enrolled in the programme.[71] This suggests that a sizable portion of the HCV-infected population who have not been successfully treated may be receptive to this type of intervention. However, more translational research is needed to more fully answer this question.

It is important to note that the intervention is not designed for patients who are receiving antiviral treatment. Although they comprise a minority of all HCV-infected patients, patients on medication must cope with a variety of difficult side effects and manage their medications carefully. Thus, they may need even more supportive resources because antiviral treatment poses unique challenges, but patients on antiviral treatment are also usually higher functioning on average than those who are ineligible for treatment. In general, more healthcare resources are devoted to helping patients receiving antiviral treatment, which highlights the need for interventions like the HCV-SMP, which serve those who are not on antiviral treatment. Conceivably, the current programme could be extended to patients on antiviral therapy, but efficacy would need to be tested with patients on antiviral treatment.

Study enrolment was limited to patients with VA with hepatitis C, so our conclusions may not generalize well beyond the VA system. However, similar self-management programmes addressing other diseases have been studied extensively in nonveteran samples and have regularly produced good results. The intervention will be studied in nonveteran samples in the future.

A possible limitation of the study is that eligibility for the study and the intervention itself required participants to attend six self-management sessions at a large medical centre. Classes were typically held on weekday afternoons because that was the time when most individuals were available. This excluded people who could not attend during these times, or those who lived in distant areas. Thus, it may be helpful to explore options for greater time flexibility and delivering this type of intervention to remote sites using medical informatics.
In conclusion, the hepatitis C self-management programme produced a number of important health benefits among patients with VA with chronic hepatitis C infection. There are few, if any, interventions available for HCV-infected individuals who have failed, or are not immediate candidates for antiviral therapy and this group makes up almost three quarters of all HCV-infected persons. The programme is broad and may impact general health and other co-morbid disorders instead of just HCV itself. Planned research will examine longer term outcomes and clinical outcomes and costs. If successful, the intervention is a model for larger scale implementation in the VA and other systems with large numbers of disadvantaged HCV-infected patients