Background
Research aims
Methods
Trial registration and ethics approval
Study setting and participants
Data collection
The intervention – ‘The Healthy Brain Rehabilitation Manual’
Randomisation and blinding
Study design
Data treatment and statistical analysis
Qualitative work
Results
Recruitment, retention and completion of assessment measures
Baseline characteristics
Group 1 (Control) | Group 2 (Manual) | Group 3 (Manual + pedometer) | |
---|---|---|---|
Number of patients | 5 | 5 | 5 |
Sex (M – male, F – female) | 4 M 1F | 4 M 1F | 2 M 3F |
Diagnosis | 1 TIA | 4 TIA | 4 TIA |
4 Minor stroke | 1 Minor stroke | 1 Minor stroke | |
Mean age (years) | 76.2 | 67.8 | 63 |
Mean time (days) event to enrolment (Standard Deviation (SD)) | 19.8 (SD 7.09) | 22.2 (SD 9.18) | 19.6 (3.58) |
Level of education | 3 High school | 3 High school | 1 High school |
2 Further Education College | 2 Further Education College | 3 Further Education College | |
1 University | |||
Employment | 1 Employed | 2 Employed | 1 Employed |
4 Retired | 1 Unemployed | 4 Retired | |
2 Retired | |||
Multiple deprivation measure (MDM) median (range)a
| 784 (51–863) | 413 (250–726) | 681 (333–825) |
Family history of cardiovascular disease (<55 years for males, <65 years old for females) | 4 | 3 | 3 |
Marital status | 1 Single | 5 Married | 4 Married |
4 Married | 1 Divorced | ||
Smoking status | 2 non-smokers | 2 non-smokers | 3 non-smokers |
3 ex-smokers | 2 ex-smokers | 2 ex-smokers | |
1 current smoker | |||
Modified Rankin scale | |||
0 | 2 | 2 | 4 |
1 | 1 | 1 | 1 |
2 | 1 | 1 | 0 |
3 | 0 | 1 | 0 |
4 | 1 | 0 | 0 |
Post-intervention assessment
Group 1 (Control) – baseline | Group 1 – post-intervention | Group 2 (Manual) – baseline | Group 2 – post-intervention | Group 3 (Manual + pedometer) – baseline | Group 3 – post-intervention | |
---|---|---|---|---|---|---|
IPAQ category | ||||||
Inactive | 2 | 1 | 3 | 1 | 1 | 0 |
Minimally active | 1 | 4 | 1 | 0 | 2 | 1 |
Health-enhancing physical activity levels | 2 | 0 | 1 | 4 | 2 | 4 |
IPAQ continuous score (Mean (SD)) | 1514.6 (SD 1470.1) | 1093.8 (SD 851.1) | 870.4 (SD 948.2) | 4366.2 (SD 3140.8) | 1531.2 (SD 902.5) | 5335.8 (SD 3133.6) |
IPAQ number of hours sitting/day | 6.20 (SD 4.10) | 6.3 (SD 4.0) | 4.80 (SD 1.5) | 3.2 (SD 1.3) | 5.00 (SD 1.0) | 3.8 (SD 1.3) |
Steps/day | 8356 | 9762.8 (SD 3473.5) | ||||
Stages of change for physical activity | ||||||
1 | 1 | 1 | 1 | 0 | 0 | 0 |
2 | 0 | 0 | 3 | 0 | 1 | 0 |
3 | 2 | 2 | 0 | 1 | 1 | 0 |
4 | 0 | 0 | 0 | 3 | 2 | 4 |
5 | 2 | 2 | 1 | 1 | 1 | 1 |
Mediterranean diet total score | 5.6 (SD 3.1) | 5.8 (SD 2.5) | 6.2 (SD 3.3) | 8.4 (SD 2.3) | 6.0 (SD 2.2) | 8.0 (SD 1.4) |
Number of pieces of vegetables/day | 1.6 (SD 1.1) | 1.8 (SD 1.5) | 2.2 (SD 1.8) | 2.4 (SD 0.6) | 2.0 (SD 1.2) | 2.8 (SD 0.8) |
Number of pieces of fruit/day | 2.2 (SD 1.9) | 2.6 (SD 1.5) | 2.2 (SD 1.3) | 2.8 (SD 1.3) | 3.4 (SD 0.9) | 4.0 (SD 1.4) |
Systolic blood pressure (mmHg) | 135.8 (SD 8.4) | 135.8 (SD 24.8) | 136.2 (SD 15.2) | 128 (SD 2.0) | 129.4 (SD 15.2) | 131.0 (SD 12.9) |
Diastolic blood pressure (mmHg) | 76.4 (SD 10.8) | 76.8 (SD 10.0) | 82.8 (SD 13.9) | 74.8 (SD 4.0) | 77.2 (SD 8.1) | 80.4 (11.2) |
Resting heart rate (beats per minute) | 66.2 (SD 3.0) | 71.6 (SD 8.4) | 65.6 (SD 0.9) | 74.8 (SD 4.0) | 75.0 (SD 9.4) | 73.8 (SD 10.8) |
2 min walk test performance (metres walked) | 109.5 (SD 46.3) | 118.2 (SD 28.2) | 128.8 (SD 29.1) | 149.8 (SD 28.7) | 136.5 (SD 41.5) | 163.4 (SD 23.4) |
Weekly alcohol intake (units/week) | 6.4 (SD 12.1) | 5.6 (SD 8.4) | 5.6 (SD 10.4) | 1.6 (SD 2.6) | 2.8 (SD 3.0) | 2.4 (SD 2.6) |
HADs total score | 10.6 (SD 6.5) | 11.0 (SD 5.2) | 10.4 (SD 4.7) | 7.4 (SD 5.5) | 7.00 (SD 4.2) | 3.8 (SD 2.7) |
HADs Anxiety score | 6.0 (SD 4.1) | 6.2 (SD 3.6) | 6.0 (SD 2.1) | 4.2 (SD 3.5) | 5.2 (SD 2.8) | 3.0 (SD 2.0) |
HADs Depression score | 4.6 (SD 3.2) | 4.8 (SD 2.4) | 4.4 (SD 3.1) | 3.2 (SD 2.4) | 1.8 (SD 1.9) | 0.8 (SD 0.1) |
EQ5D5L overall score | 0.7 (SD 0.4) | 0.7 (SD 0.4) | 0.9 (SD 0.1) | 1.0 (SD 0.1) | 1.0 (SD 0.0) | 1.0 (SD 0.1) |
EQ5D5L VAS score | 66.0 (SD 32.1) | 53 (SD 29.7) | 72.0 (SD 17.5) | 86 (SD 6.5) | 83.0 (SD 18.2) | 85.8 (SD 17.6) |
Weight (kg) | 80.6 (SD 10.9) | 80.3 (SD10.9) | 80.7 (SD 8.1) | 80.1 (SD 8.2) | 79.6 (SD 15.6) | 79.4 (SD 16.5) |
BMI (kg/m2) | 27.3 (SD 2.5) | 27.2 (SD 2.5) | 29.7 (SD 3.2) | 29.5 (SD 3.4) | 28.2 (SD 2.2) | 28.1 (SD 2.2) |
Waist circumference (cm) | 97.7 (SD 5.7) | 97.7 (SD 5.7) | 99.9 (SD 6.1) | 98.7 (SD 6.5) | 101.2 (SD 11.3) | 100.4 (SD 11.1) |
Qualitative findings
Use of the manual
“…there was some days when I was panicking a bit and I got the book out and I was like, no, that symptom is ok, that’s normal….” (F)
Participants’ comments reflected their fear and uncertainty about their future health, attributed to their experience of sudden onset symptoms of their TIA or minor stroke. Some appeared to be in denial of their diagnosis, based on a rationale that their symptoms had been mild (predominantly affecting vision and speech; one had right-sided weakness) and transient but their comments also reflected a sense of uncertainty. However, the manual was welcomed by all as a reference source for credible information that helped them to understand their diagnosis.“I think this (the manual) should be at doctor (GP) surgeries as well because when you go to speak to the doctor you get conflicting advice at times.” (F)
“It (the TIA) just frightened me and knocked my confidence… because you get no warning.” (F)
“You know, for just 10 minutes’ worth of symptoms, surely nothing serious could have happened?” (F)
Family members also used the manual in supporting decision-making about seeking medical help. Some did so effectively but others were less helpful: one participant’s comments indicated how her family members wished they could deny the significance of her symptoms.“I thought it was excellent…….. like a bible” (M)
“…I was just going to go to my bed but my daughter phoned and I said to her the symptoms I was having and she took me straight to Accident and Emergency (A&E) department.” (F)
Other information in the manual provided reassurance for those who felt guilty about not being able to fulfil their previous work-life commitments, particularly as they had no visible physical manifestations of illness. Information regarding the relevance of healthy lifestyle behaviours in helping to reduce risk of further events was valued and participants reported having continued to access it after the study programme had ended: some reported that they put the manual in a prominent place to remind them to sustain preventive behaviours. Other comments indicated how family members used the manual to encourage maintenance of healthy behaviours. Those who had received positive feedback about progress in reducing their risk factors attributed this to having followed guidance in the manual.“My daughters didn’t want to read it because if you read it, then it’s true…” (F)
“I felt an awful fraud cause I was off work but there was nothing physically wrong with me…nothing to show ” (F)
“I lift it every morning, read a wee bit, remind myself why I’m not smoking, why I’m not eating a whole load of pastries and why I’m avoiding salt….I might just read a line but it’s the very fact that it’s sitting there, reminding me of what to do right….I find that very important…” (M)
“my grand-daughter has read it from page to page and every time she comes up to see me, she’s like, ‘grandad, have you done that? Are you keeping to that?” (M)
“The fact that my blood pressure is a lot lower is also very encouraging for me to stay with the programme as I feel the things which I have done have definitely helped me…” (F).
The study design
“………they made me feel that there was someone out there interested in me and who cares for me.” (M)
“...it put your mind at rest because you were thinking, NH is phoning me soon, so I don’t need to go to see the GP. I enjoyed the explanations.” (F)
Intervention components - pedometers“…..are we going to get to go on holiday and will I be able to fly?” (F)
“…it’s a competition between me and the wife who walks the furthest” (M)
“ It was just so addictive …. I had that visual target to aim for…It would also send me an email at the end of the week, telling me how much activity I had done and I just thought it was brilliant.” (F)
Outcome assessments“…and the pedometer would always be less (in step-count measurement compared to Fitbit)….” (F)
“I doubt that I would have been able to do the treadmill exercise test within 4 weeks of having the TIA….” (M)
“I would be interested in doing it now…” (Two Fs)
Suggested changes
“…. the explanation for the TIA (and minor stroke) is at the back of the manual. I think it should be at the start?’” (F)
“people are interesting and it’s good to hear their experiences…” (F)