(Stroke. 1999;30:2585.)
© 1999 American Heart Association, Inc.
Original Contributions |
Randomized Controlled Trial of a Comprehensive Stroke Education Program for Patients and Caregivers
From the School of Clinical Medical Science (H.R., C.A.,R.D., R.C.) and the School of Health Sciences (H.R., S.B., R.D.), University of Newcastle on Tyne, Newcastle on Tyne, England; and North Tyneside General Hospital (H.R., M.S., R.C.), Northumbria Health Care NHS Trust, North Shields, Tyne and Wear, England.
Correspondence to Dr Helen Rodgers, Senior Lecturer in Stroke Medicine and Services, Centre for Health Services Research, 21 Claremont Place, The University Newcastle on Tyne NE2 4AA, England. E-mail helen.rodgers{at}ncl.ac.uk
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Abstract |
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Background and Purpose—We report the findings of a randomized controlled trial to determine the effectiveness of a multidisciplinary Stroke Education Program (SEP) for patients and their informal carers.
Methods—Two hundred four patients admitted with acute stroke and their 176 informal carers were randomized to receive an invitation to the SEP or to receive conventional stroke unit care. The SEP consisted of one 1-hour small group educational session for inpatients followed by six 1-hour sessions after discharge. The primary outcome measure was patient- and carer-perceived health status (SF-36) at 6 months after stroke. Knowledge of stroke, satisfaction with services, emotional outcome, disability, and handicap and were secondary outcome measures.
Results—Only 51 of 108 (47%) surviving patients randomized to the SEP completed the program, as did 20 of 93 (22%) informal carers of surviving patients. Perceived health status (Short Form 36 [SF-36] health survey) scores were similar for SEP patients and controls. Informal carers in the control group scored better on the social functioning component of the SF-36 than the SEP group (P=0.04). Patients and informal carers in the SEP group scored higher on the stroke knowledge scale than controls (patients, P=0.02; carers, P=0.01). Patients in the SEP group were more satisfied with the information that they had received about stroke (P=0.004). There were no differences in emotional or functional outcomes between groups.
Conclusions—Although the SEP improved patient and informal carer knowledge about stroke and patient satisfaction with some components of stroke services, this was not associated with an improvement in their perceived health status. Indeed, the social functioning of informal carers randomized to the SEP was less than in the control group.
Key Words: stroke management • clinical trials • rehabilitation
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Introduction |
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TopAbstractIntroductionSubjects and MethodsResultsDiscussionReferences |
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The need for better information, in addition to greater provision of support, has been voiced by stroke patients and their informal carers.1 Over 10 years ago, a UK Consensus Statement on the treatment of stroke recommended that stroke patients and their informal carers were entitled to "a clear account of the nature and causes of their stroke... and [that] more information rather than less should be given."2 However, evidence suggests that many patients and carers continue to express a lack of understanding about stroke and its causes, secondary preventative measures, and information about both statutory and informal support.3 4 5
Information needs of patients and informal carers in hospital and after discharge are not being met, despite the efforts of health services and voluntary agencies.3 4 6 7 It is not unusual for patients and carers to report that they have not received any information about their illness, despite having had discussions with health professionals and being given written information. This could occur for a number of reasons: the information was not retained due to the stress of the situation, was not clear, was too complicated, was too general, or did not address the patient or carer’s own issues of concern.
A study of stroke patients’ and carers’ satisfaction with care reported that although 89% were satisfied with their overall care, 49% were dissatisfied with the information they had received while in hospital.8 These results were mirrored in an audit undertaken at North Tyneside General Hospital in 1996, which found that although only 15% of stroke patients and carers felt dissatisfied with their care in general, 40% of stroke patients and 45% of their informal carers were dissatisfied with the information received about stroke before discharge. In light of these findings, a multidisciplinary group consisting of stroke unit staff, community nurses, and representatives from the Stroke Association and the local voluntary sector developed a Stroke Education Program (SEP) that was available to stroke patients admitted to North Tyneside General Hospital and their main informal carer.
The aim of the present study was to determine the effectiveness of the Stroke Education Program for improving patients’ and carers’ perceived health status through enhancement of their knowledge of the causes and consequences of stroke and the availability of community support.
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Subjects and Methods |
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TopAbstractIntroductionSubjects and MethodsResultsDiscussionReferences |
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The study was a pragmatic randomized controlled trial and was approved by the local ethical committee.
Study Participants
North Tyneside General Hospital has an organized stroke service
that cares for all patients admitted with acute stroke. All such
patients admitted between January 1, 1997, and December 1, 1998, and
their informal carer (next of kin or the person providing most
day-to-day support), were approached between 5 and 9 days after stroke.
Patients who were too unwell at that time were reassessed once
medically stable. Patients were excluded if they were discharged within
24 hours, lived outside of the study area, or were admitted from a
residential or nursing home. Zelen’s 2-stage method of consent was
used.9 The initial assessment comprised a structured
interview that covered demographic details, age at which patient ended
full-time education, comorbidity, a screening test for cognitive
impairment,10 prestroke function,11 support
and services, and stroke subtype.12 When it was not
possible to obtain information from the patient (for example, because
of dysphasia or cognitive impairment), the information was sought from
their informal carer and supplemented when appropriate from medical
notes. Patients who were unable to complete the interview and had no
carer were excluded from the study. The Barthel Activities of Daily
Living (ADL) Index at 7 days after stroke was
recorded.13 For informal carers, the initial
assessment consisted of demographic details, background, and prior
experience as a carer.
Randomization
Stroke patients and their informal carer were randomized through
a central telephone service to receive either an invitation to attend
the SEP or conventional stroke unit care. Randomization was
computerized, and the patient and informal carer (when present)
were randomized as a pair. Patients were initially randomized in blocks
of 8 and were stratified by continence of urine at 24 hours after
stroke as a proxy marker for stroke severity14 and by
presence of an informal carer. Due to low initial compliance with the
SEP, the randomization process changed in the seventh month of the
study. Patients were then randomized in a ratio of 2 SEP to 1
conventional care. Randomization was then done in blocks of 9.
Stroke Education Program
The SEP consisted of a rolling program of one 1-hour small-group
educational sessions for inpatients and their informal carer followed
by six 1-hour educational sessions after discharge from hospital. The
SEP aimed to improve knowledge of the nature of stroke and of the
rationale for treatment and therapeutic interventions; increase
awareness of services available while in hospital or after discharge;
give advice and information about the prevention of stroke; and provide
an opportunity for patients and carers to ask questions and gain
support within an informal group setting. An outline of the content of
the SEP is given in Table 1
. Each
session was led by a member of the multidisciplinary team, and the SEP
included input from nursing, physiotherapy, occupational therapy,
speech and language therapy, clinical psychology, social work, district
nursing, the local carers center, and the stroke club. Group sessions
were held 1 morning per week in the day hospital situated at the main
hospital site. Transport was provided for those who required it. We
defined attendance at the SEP as those who attended 
3 outpatient
group sessions. Those randomized to the SEP were sent a questionnaire
by mail after either completion of the SEP or nonattendance. The
questionnaire sought their views about the program or reasons for
nonattendance. Nonresponders were sent a postcard reminder at 2 weeks
followed by another copy of the questionnaire after an additional 2
weeks.
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Information Received by the Control Group About Stroke and
Services
In addition to routine communication with nurses, doctors, and
therapy staff members throughout their inpatient stay, all patients
admitted to the stroke unit and their informal carer received an
information leaflet about the stroke service on admission. Patients and
informal carers were invited to take Stroke Association leaflets on a
number of topics, which were clearly displayed in the ward. The Stroke
Care Pathway, a multidisciplinary record, was used for all
inpatients,15 and it was readily available to patients,
carers, and staff members. The record provided and recorded
information given to patients and informal carers about aspects of
stroke. Before discharge, patients and informal carers were given
details of a telephone "hotline" run by the stroke unit that they
could contact.
Outcome Measures
Patients and their informal carers were interviewed in their own
homes at 6 months after stroke by a researcher who was blinded to the
randomization group. The primary outcome measure was patient’s and
informal carer’s perceived health status, as assessed by the Short
Form 36 healthy survey questionnaire (SF-36).16 Knowledge
of stroke, satisfaction with services, emotional outcome (patients,
Hospital Anxiety and Depression Scale17 ; carers, General
Health Questionnaire 30),18 disability, and handicap
(Nottingham E-ADL11 and Oxford Handicap
Scale)19 were secondary outcome measures. The knowledge of
stroke scale consisted of 26 items selected from other
instruments4 and the content of the SEP.20 21
The reliability and validity of this instrument has not been formally
tested. Patient and informal carer satisfaction was measured by use of
instruments from previous studies.22 23 24 The informal
carers of patients who died during the course of the study were not
contacted further. Proxy measures of perceived health status or
emotional outcome were not obtained. When a patient was unable to
complete disability or handicap scales, this information was obtained
by proxy from the informal carer.
Analysis
From audit data, we estimated that 30% of patients would not be
able to participate in the SEP as a result of dysphasia or cognitive
impairment and that 15% of stroke patients would have no carer. Using
a 1-tailed test for independent samples with a power of 80% and a
significance level of 5%, we estimated that 80 patients and 108 carers
in each randomization group would enable us to detect differences
ranging from 5 to 10 points in the subscales of the SF-36 at 6 months.
Data were analyzed on an intention–to-treat basis with
nonparametric techniques to allow for nonnormative data
distribution. The main comparative analyses were made with the
Mann-Whitney U test. For ordered categorical variables,
the 
2 test was used to detect differences in
proportions; a 2-sided 5% significance level was used throughout. Odds
ratios and 95% confidence intervals were used to analyze
responses to questions about satisfaction.
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Results |
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TopAbstractIntroductionSubjects and MethodsResultsDiscussionReferences |
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Three hundred ninety-eight patients were admitted with acute stroke during the study period. Two hundred four patients and 176 informal carers agreed to participate. Figure 1
shows the trial profile. Table 2 shows the baseline characteristics of
study subjects. Groups were well matched. More total anterior
circulation stroke patients were randomized to SEP, but this was not
statistically significant. No statistically significant differences
occurred in stroke severity as measured by the Barthel ADL Index at 7
days after stroke, length of stay, or discharge destination.
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SEP attendance was low: 51 stroke patients and 20 informal carers
attended 3 outpatient sessions, of whom 55 (77%) returned the
evaluation questionnaire. Forty-four (80%) felt that the SEP was
beneficial and overall feedback from attendees was positive.
Forty-seven (85%) felt that it had been helpful to talk to other
people who had had a stroke and their relatives. Thirty-nine (71%)
felt that they had been able to use the information gained from the SEP
in their everyday life.
Patients who attended the SEP did not differ from nonattenders with regard to age, sex, age at which full-time education was ended, and stroke severity, but they had a higher level of activity before stroke (median Nottingham E-ADL, 17 versus 16; P=0.05). Prestroke Oxford Handicap Scores did not differ. No demographic differences existed between carers who did and did not attend.
The response rate to the questionnaire by SEP nonattenders was low: only 18 patients and 33 carers who did not attend returned questionnaires, which gave a response rate of 33%. Reasons given for nonattendance by patients included poor health, lack of interest, and difficulty getting to the hospital. Informal carers stated that they were unable to attend because of their own poor health, work commitments, or lack of interest.
Primary Outcome
Table 3 shows patient and carer
SF-36 scores at 6 months after stroke. Thirty-seven of 154 (24%)
patients who agreed to a 6-month outcome interview did not complete the
SF-36, mainly as a result of dysphasia or cognitive impairment. No
differences in SF-36 scores were seen when patient and informal carer
scores were analyzed together. However, separate
analyses of patient and informal carer scores found that
informal carers randomized to the SEP had lower social-functioning
subscale scores compared with controls (P=0.04).
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Secondary Outcomes
Table 4 shows knowledge about stroke
and emotional and functional outcomes at 6 months after stroke. Both
patients and informal carers randomized to the SEP program had higher
scores on the knowledge of stroke scale than controls
(P=0.02 and P=0.01). Both groups of patients had
high scores on the Hospital Anxiety and Depression (HAD) Scale
but did not differ. Informal carers also did not differ in General
Health Questionnaire 30 (GHQ-30) scores, which showed high levels of
stress. No differences occurred between intervention and control groups
in patients’ functional outcomes.
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Figures 2 and 3 show patient and informal carer
satisfaction with services. Patients but not carers who were randomized
to SEP were more satisfied with the information they received about
stroke than were controls.
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The sensitivity of researcher to correctly identify the randomization group after the 6-month assessment interview was 0.40 and specificity, 0.98.
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Discussion |
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TopAbstractIntroductionSubjects and MethodsResultsDiscussionReferences |
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Although the SEP improved patient and informal carer knowledge about stroke and increased some aspects of satisfaction with services, this was not associated with an improvement in their perceived health status. Providing patients with information and education has been shown to improve outcome in several other chronic conditions.25 26 27 28
Social functioning, as measured by the SF-36, of informal carers randomized to the SEP was lower than in the control group. Several explanations could explain this finding: the SEP may have increased carers’ awareness of the nature and consequences of stroke and as a result, they may have reduced their social activities to spend more time with the patient or attending the SEP may have resulted in reduced social activities, particularly for those who needed to ask a friend or relative to stay with the stroke patient while they left the house. Although the SEP gave carers a better understanding of stroke and its consequences and may have provided them with professional and peer group support, it was not always possible to provide them with a positive solution to their problems. Alternatively, this could be a chance finding, given that the study did not show consistently adverse carer outcomes in the SEP group.
The finding of lower social functioning in carers randomized to the SEP
should be treated with caution, given that we have seen a statistically
significant difference in only 1 of the 7 subscales of the SF-36,
particularly because the social functioning subscale contains only 2
items, which are similar. The internal consistency of the
social functioning subscale is the lowest of all of the subscales
(Cronbach’s 
=0.76).29 30 Ideally, this value should
exceed 0.8.31 The internal reliability and coefficient of
reliability of this subscale are also lower than for other subscales
but are considered to be within acceptable limits.30
The SF-36 was selected as the primary outcome measure because it is one of the most widely used generic measures of health status and has been used with stroke patients previously.32 33 34 However, concerns are emerging about both the response rates and individual item relevance to older people.35 36 37 To improve completeness, questionnaires were initially sent by mail and checked for completeness at the interviewer visit. It would have been valuable to have had a measure that could have been used by proxy, given the proportion of patients (24%) who were unable to complete the SF-36 due to language or cognitive problems. There is a need to use a stroke-specific measure of health status as well as a generic measure in studies of this kind, but we are not aware of any measure whose validity and reliability has yet been adequately tested.
The study was prone to a type II error. Although the numbers of patients recruited was as anticipated, we overestimated the proportion of patients who were able to complete the SF-36 at 6 months after stroke. Thus, patient SF-36 scores were only available for 117 of 154 (76%) 6-month survivors, which represents 73% of patients of the requirements defined in the original power calculation (117 of 160).
At recruitment, informal carers were identified for only 176 of 204 (86%) of patients. Available carer outcome SF-36 scores at 6 months after stroke were available for 106 of 176 (60%) of recruited carers. This was considerably less than originally estimated in the power calculation, 106 of 216 (49%).
Attendance at the SEP was disappointingly low, which would have diluted any treatment effect. Nevertheless, the SEP was well received and valued by those who attended, and we have demonstrated a clear benefit of the SEP in improving patient and carer knowledge of stroke and satisfaction with services.
This study suggests that improved knowledge about stroke may not be associated with improved health status and psychological outcomes. This raises issues about the content, timing, delivery, and duration of the program, which provides information for stroke patients and carers. However, it also raises questions about the potential adverse effects of increasing knowledge.
Information needs vary over time and circumstances and may continue for several years after stroke.7 Discharge from hospital is very stressful for patients and informal carers; some feel abandoned by services once they have returned home, and they are uncertain who to turn to for information and practical help.38 At this time, a lack of knowledge about stroke, the longer-term consequences, and the support available are associated with increased anxiety and worry and may contribute to patients’ failure to realize their maximal potential after discharge.
Psychological morbidity is high after stroke and poorly addressed, given the current emphasis upon physical recovery within rehabilitation.39 40 Despite our awareness of this issue and attempts to address psychosocial support issues within the SEP, patient anxiety levels were high but not different in both randomization groups.
Research of other chronic conditions suggests that personalized information can lead to better quality of life.25 41 In stroke, small randomized controlled trials of written information have found that although there was increased knowledge20 42 43 and satisfaction with information in those who received written information,20 42 no differences existed in patients’ quality of life.20 43 Improved carer mental health was found in 1 study.43
The SEP also aimed to provide support within an informal group. Other studies have evaluated services that provide individual support or counseling in addition to information.24 44 45 46 47 Although education was found to improve some aspects of family functioning, the addition of counseling was associated with better outcomes.45 Provision of a structured, personalized information program to patients and carers by a specialist nurse in their own home in the 12 months after discharge resulted in no differences in outcome between intervention and control groups.46 However, the qualitative component of this study found that patients and carers visited by a specialist nurse felt that they had received personalized support and information, but the control group felt that they lacked personally relevant information that would have helped them practically and emotionally.47 Although visits by a stroke family care worker improved patient and carer satisfaction with services, they had no measurable effect on physical, psychological, or social outcomes of patients and carers.24
Providing patients and carers with information about stroke may be insufficient to improve health status. It is important to realize that services developed by caring enthusiastic health professionals to meet the expressed need for information by stroke patients and their informal carers may not be necessarily beneficial. Further work is needed to investigate the relationship between knowledge of stroke, how such knowledge is provided, and perceived health status. Before beginning an additional randomized controlled trial of an educational intervention, we intend to undertake further development work that involves patients, carers, and experts in health education to more clearly identify optimal ways of meeting patient and carer information needs and improving problemsolving skills.
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Acknowledgments |
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This study was funded by Northern and Yorkshire Regional Health Authority National Health Service Research and Development Directorate. We would like to thank all of the study participants and those who contributed to the SEP (J. Bilclough, M. Smith, A. Scott, M. Jones, K. Rossiter, C. Herbert, J. Caverhill, J. Greer, C. Isles, A. Macreggor, B. Harding, S. Tiplady, J. Hutton, T. Davies, C. Card, and J. Passman). Particular thanks is due to Pat Scott for her help with data collection, Dawn Winpenny and Gillian Manson for secretarial support, Nick Steen for statistical advice, and Laura Bond, our project secretary.
Received July 9, 1999; revision received September 13, 1999; accepted September 13, 1999.
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K. M. Buckley Commentary by Buckley West J Nurs Res, April 1, 2007; 29(3): 357 - 359. [PDF]
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D. B. Lowe, A. K. Sharma, and M. J. Leathley The CareFile Project: a feasibility study to examine the effects of an individualised information booklet on patients after stroke Age Ageing, January 1, 2007; 36(1): 83 - 89. [Abstract] [Full Text] [PDF]
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 J. Redfern, C. McKevitt, and C. D.A. Wolfe Development of Complex Interventions in Stroke Care: A Systematic Review Stroke, September 1, 2006; 37(9): 2410 - 2419. [Abstract] [Full Text] [PDF]
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P. W. Duncan, R. Zorowitz, B. Bates, J. Y. Choi, J. J. Glasberg, G. D. Graham, R. C. Katz, K. Lamberty, and D. Reker Management of Adult Stroke Rehabilitation Care: A Clinical Practice Guideline Stroke, September 1, 2005; 36(9): e100 - e143. [Full Text] [PDF]
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L. Robinson, J. Francis, P. James, N. Tindle, K. Greenwell, and H. Rodgers Caring for carers of people with stroke: developing a complex intervention following the Medical Research Council framework Clinical Rehabilitation, May 1, 2005; 19(5): 560 - 571. [Abstract] [PDF]
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H. Boter and for the HESTIA Study Group Multicenter Randomized Controlled Trial of an Outreach Nursing Support Program for Recently Discharged Stroke Patients Stroke, December 1, 2004; 35(12): 2867 - 2872. [Abstract] [Full Text] [PDF]
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J. Smith, A. Forster, and J. Young A randomized trial to evaluate an education programme for patients and carers after stroke Clinical Rehabilitation, July 1, 2004; 18(7): 726 - 736. [Abstract] [PDF]
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J M A. Visser-Meily, M. W M Post, I. I Riphagen, and E. Lindeman Measures used to assess burden among caregivers of stroke patients: a review Clinical Rehabilitation, June 1, 2004; 18(6): 601 - 623. [Abstract] [PDF]
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 G. J Hankey Informal care giving for disabled stroke survivors BMJ, May 8, 2004; 328(7448): 1085 - 1086. [Full Text] [PDF]
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H. Boter, G. J. Rinkel, and R. J de Haan Outreach nurse support after stroke: a descriptive study on patients' and carers' needs, and applied nursing interventions Clinical Rehabilitation, February 1, 2004; 18(2): 156 - 163. [Abstract] [PDF]
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M. S Clark, S. Rubenach, and A. Winsor A randomized controlled trial of an education and counselling intervention for families after stroke Clinical Rehabilitation, July 1, 2003; 17(7): 703 - 712. [Abstract] [PDF]
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M. Fisher Recommendations for Advancing Development of Acute Stroke Therapies: Stroke Therapy Academic Industry Roundtable 3 Stroke, June 1, 2003; 34(6): 1539 - 1546. [Abstract] [Full Text] [PDF]
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