Table 1.
Study and setting | Study type (duration) | Participants | Sample size (intervention/controls) | Subgroups analysed | Interventions | Quality judgment* | Outcome measures extracted† | Results |
---|---|---|---|---|---|---|---|---|
Artinian 2001,*26 family community centre, Detroit, USA | Pilot randomised controlled trial (three months) | African Americans aged >18 years with systolic blood pressure >140 mm Hg or diastolic 90 mm Hg (>130 mm Hg or >85 mm Hg if diabetes or previous myocardial infarction) | 6/6/9 | Telephone monitoring, community. monitoring, and ethnicity | Group 1: two nurse visits and then weekly telephone feedback to nurse on home blood pressure measurements (home telemonitoring plus usual care); group 2: 12 weekly nurse visits to feedback home blood pressure measurements (community monitoring plus usual care); group 3: usual doctor care with blood pressure measured twice with automated monitor (UA 767PC; A&D Medical, San Jose, CA, USA), five minutes apart after five minutes’ rest. Mean blood pressure recorded | Sequence generation adequate, allocation concealment unclear (not described), blinding adequate | Systolic and diastolic blood pressure | Systolic: group 1, 124.1 (SD 13.8) mm Hg; group 2, 142.3 (SD 12.1) mm Hg, group 3, 143.3 (SD 12.7) mm Hg. Diastolic: group 1, 75.65 (SD 11.4) mm Hg; group 2, 78.3 (SD 6.9) mm Hg; group 3, 89.1 (SD 10.6) mm Hg |
Artinian 2007,*29 Detroit, USA | Randomised controlled trial (12 months) | African Americans aged >18 years with systolic blood pressure ≥140 mm Hg or diastolic ≥90 mm Hg (>130 mm Hg or >80 mm Hg if diabetes or renal disease) | 167/169 | Telephone monitoring and ethnicity | Self monitoring blood pressure at home sent over telephone to nurse; trained nurse visited patient twice at home to teach about, deliver, and set up blood pressure equipment. When telephone data received, nurse telephoned patient about lifestyle and adherence to treatment. Blood pressure measured twice with automated monitor (HEM-737; Omron, Japan) after five minutes’ rest. Mean blood pressure recorded | Sequence generation adequate, allocation concealment adequate, blinding: adequate | Systolic and diastolic blood pressure | Systolic: 145.0 (SD 21.0) mm Hg for intervention, 148.1 (SD 22.3) mm Hg for control. Diastolic: 83.8 (SD 12.1) mm Hg for intervention, 83.5 (SD 13.6) mm Hg for control |
Bebb 2007,18 42 general practices, Nottingham, England | Cluster randomised controlled trial; randomised at practice level (12 months) | People with type 2 diabetes aged 18-80, with blood pressure ≥140/90 mm Hg | 20/22 clusters, 797/737 participants | Algorithm | Treatment algorithm for management of hypertension in type 2 diabetes followed by practice nurses and general practitioners. Blood pressure measured twice with automated monitor (HEM-705CP; Omron, Japan) after five minutes’ rest, and repeated third time if >10% difference. Mean of last two readings recorded | Sequence generation adequate, allocation concealment adequate, blinding inadequate (could not blind clinicians to intervention) | Systolic and diastolic blood pressure; blood pressure target <140/80 mm Hg with treatment or <140/90 mm Hg; and proportion receiving treatment | Systolic: 143.0 (SD 19.5) mm Hg for intervention, 143.1 (SD 17.7) mm Hg for control. Diastolic: 78.2 (SD 10.2) mm Hg for intervention, 77.9 (SD 10.4) mm Hg for control. Target blood pressure: 272/743 for intervention, 232/677 for control. Treatment received: 526/743 for intervention, 471/677 for control |
Becker 2005,24 Baltimore, USA | Cluster randomised controlled trial; randomised at family level (12 months) | African Americans aged 30-59. Siblings of probands with coronary heart disease aged <60 identified at admission | 92/102 clusters, 196/168 participants | Algorithm, community monitoring, nurse prescribing, and ethnicity | Group 1: community based care, in a non-healthcare setting, 30 minute sessions with blood pressure measurement and evaluation of treatment by nurse practitioner, and diet, exercise, and smoking counselling by community health worker. Nurse responsible for communicating changes of treatment and decisions on application of guidelines. Group 2: enhanced primary care (control), family physicians and patients given information from baseline assessment and same guidelines but left to usual care of family physician. Method of blood pressure measurement not described | Sequence generation adequate, allocation concealment adequate, blinding inadequate (could not blind nurse practitioners to delivery of community based care) | Systolic and diastolic blood pressure and use of antihypertensive drugs | Systolic: 130 (SD 14) mm Hg for intervention, 134 (SD 17) mm Hg for control. Diastolic: 84 (SD 9) mm Hg for intervention, 85 (SD 10) mm Hg for control. Antihypertensive drugs: 102/196 for intervention, 69/168 for control |
Bellary 2008,19 21 general practices in Coventry and Birmingham, England | Cluster randomised controlled trial; randomised at practice level (24 months) | South Asian adults with type 2 diabetes | 9/12 clusters, 868/618 participants | Algorithm and ethnicity | Common treatment algorithms for control of blood pressure, diabetes, and lipid levels. Intervention group practice nurses received additional time (four hours per week) to run clinics and implement protocols, training in diabetes, and support from diabetes specialist nurses. All participants were supported by link workers able to provide interpretation and input in local languages. Method of blood pressure measurement not described | Sequence generation unclear (not described), allocation concealment unclear (not described), blinding inadequate (could not blind nurses to intervention) | Systolic and diastolic blood pressure, use of antihypertensive drugs, and blood pressure target 130/80 mm Hg, or 125/75 mm Hg if proteinuria present | Systolic: 134.3 (SD 21.1) mm Hg for intervention, 136.4 (SD 20.3) mm Hg for control. Diastolic: 78.4 (SD 11.0) mm Hg for intervention, 81.0 (SD 11.1) mm Hg for control. Antihypertensive drugs: 660/868 for intervention, 459/618 for control. Target blood pressure: 310/868 for intervention, 191/618 for control |
Bosworth 2009,*25 primary care clinic, Durham, USA | Two level nested cluster randomised controlled trial; randomised at provider and patient level (24 months) | White (50%) or African American (43%) participants (98% men) with hypertension or taking antihypertensive drugs in previous 12 months | Group 1, 150/151; group 2, 144/143; pooled groups, 294/294 | Telephone monitoring | Providers randomised to decision support (group 1) or hypertension reminders (group 2). Their patients were randomised to nurse telephone support for behavioural change every two months (intervention) or usual care. Systolic blood pressure for patient telephone support versus usual care extracted for each group. Target achievement reported pooled across both groups. Blood pressure measurement by “trained clinic healthcare providers according to Veterans’ Affairs standards.” Clinic blood pressure readings used for study | Sequence generation adequate, allocation concealment adequate, blinding adequate | Systolic blood pressure and blood pressure target 140/90 mm Hg, or 135/85 mm Hg with diabetes | Systolic: group 1, 136.9 (SD 19.7) mm Hg for intervention, 136.8 (SD 20.8) mm Hg for control; group 2, 136.3 (SD 19.2) mm Hg for intervention, 136.8 (SD 19.1) mm Hg for control. Target blood pressure: 160/294 for intervention, 129/294 for control |
Campbell 1998,39 Scotland | Randomised controlled trial (12 months) | Participants with known coronary heart disease | 593/580 | Nurse led clinic (primary care) | Nurse run blood pressure clinics with 2-6 monthly follow-up in accordance with British Hypertension Society guidelines (1993), and referral to general practitioner if treatment needed. Method of blood pressure measurement not described | Sequence generation adequate, allocation concealment adequate, blinding inadequate (nurses not blinded) | Blood pressure target <160/90 mm Hg and use of antihypertensive drugs | Target blood pressure: 524/573 for intervention, 475/559 for control. Antihypertensive drugs: 572/593 for intervention, 510/580 for control |
Denver 2003,44 London, England | Randomised controlled trial (six months) | People with type 2 diabetes and hypertension (defined as blood pressure ≥140/80 mm Hg) and already receiving antihypertensive treatment | 59/56 | Nurse led clinic (secondary care), nurse prescribing, and ethnicity | Nurse led secondary care (outpatient) hypertension clinic. Blood pressure measured twice with automated monitor (Omron HEM-705CP, Japan) after five minutes’ rest according to British Hypertension Society guidelines. Second reading was used. Both arms checked and left arm used if no difference between arms | Sequence generation inadequate, alternate case randomisation, allocation concealment unclear (not described), blinding: inadequate (nurses and participants not blinded) | Systolic and diastolic blood pressure and blood pressure targets 140/80, or 120/70 mm Hg if renal impairment | 141.1 (SD 19.3) mm Hg for intervention, 151.0 (SD 21.9) mm Hg for control; 79.9 (SD 10.6) mm Hg for intervention, 82.2 (SD 12.4) mm Hg for control: 20/59 for intervention, 6/56 for control |
Garcia- Pena 2001,*32 Mexico | Randomised controlled trial (six months) | Participants aged ≥60 with systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥90 mm Hg at screening | 345/338 | Community monitoring | Group 1: regular nurse visits (fortnightly to monthly) at home to measure blood pressure, discuss lifestyle changes, and review drugs and adherence, plus usual physician care. Group 2: postal pamphlet about hypertension plus usual physician care. Blood pressure measured twice seated and once standing with mercury sphygmomanometer as per British Hypertension Society guidance | Sequence generation adequate, allocation concealment adequate, blinding: adequate | Systolic and diastolic blood pressure, reduction in systolic and diastolic blood pressure, use of antihypertensive drugs, and blood pressure target <160/90 mm Hg | Systolic: 155.1 (SD 17.3) mm Hg for intervention, 158.2 (SD 16.6) mm Hg for control. Diastolic: 87.4 (SD 8.6) mm Hg for intervention, 90.8 (SD 10.4) mm Hg for control. Reduction in systolic: −6.8 (SD 19.9) mm Hg for intervention, −3.5 (SD 20.2) mm Hg for control. Reduction in diastolic: −3.7 (SD 9.5) mm Hg for intervention, 0 (SD 11.3) mm Hg for control. Antihypertensive drugs: 290/345 for intervention, 247/338 for control. Target blood pressure: 125/345 for intervention, 22/338 for control |
Guerra- Riccio 2004,4 Sao Paulo, Brazil | Randomised controlled trial (six months) | Participants with hypertension attending outpatient hypertension clinic | 48/52 | Nurse led clinic (secondary care) | Group 1: visited nurse clinic every 15 days for blood pressure measurement and reinforcement of adherence to therapy, plus usual three monthly physician care. Group 2: visited nurse clinic every 90 days for blood pressure measurement and reinforcement of adherence to therapy, plus usual three monthly physician care. Blood pressure measured three times supine with mercury sphygmomanometer as per National Committee on Detection, Evaluation, and Treatment of High Blood Pressure (fifth report) guidance | Sequence generation unclear (not described), allocation concealment adequate, blinding inadequate (nurses and participants not blinded) | Reduction in systolic and diastolic blood pressure | Reduction in systolic: −36.0 (SD 41.6) mm Hg for intervention, −17.0 (SD 28.8) mm Hg for control. Reduction in diastolic: −21.0 (SD 27.7) mm Hg for intervention, −10.0 (SD 14.4) mm Hg for control |
Hill 2003,*40 Baltimore, USA | Randomised controlled trial (36 months) | African American men aged 21-54 with blood pressure >140/90 mm Hg | 125/106 | Algorithm, nurse led clinic (primary care), nurse prescribing, and ethnicity | Group 1: comprehensive individualised intervention by nurse practitioner community health worker and physician. Nurse practitioner was visited every 1-3 months and treatment changed according to protocol based on National Committee on Detection, Evaluation, and Treatment of High Blood Pressure (sixth report) guidelines. Group 2: referred to sources of hypertension care in community. Both groups received telephone reminders every six months and annual face to face reminders of importance of hypertension control, and education about benefits. Blood pressure measured using random zero sphygmomanometer three times at one minute intervals after five minutes seated. Mean of second and third measurements recorded | Sequence generation adequate, allocation concealment unclear (not described), blinding adequate | Systolic and diastolic blood pressure, reduction in systolic and diastolic blood pressure, and blood pressure target <140/90 mm Hg | Systolic: 139.3 (SD 22.2) mm Hg for intervention, 150.9 (SD 25.0) mm Hg for control. Diastolic: 89.3 (SD 15.8) mm Hg for intervention, 94.8 (SD 18.6) mm Hg for control. Reduction in systolic: −7.5 (SD 22.2) mm Hg for intervention, 3.4 (SD 25.0) mm Hg for control. Reduction in diastolic −10.1 (SD 15.8) mm Hg for intervention, −3.7 (SD 18.6) mm Hg for control. Target blood pressure: 55/125 for intervention, 33/106 for control |
Jewell 1988,38 Southampton, England | Randomised controlled trial (12 months) | Patients aged 30-64 with new (diastolic blood pressure >100 mm Hg aged 30-39 or >105 mm Hg aged >40) or uncontrolled hypertension (diastolic blood pressure >95 mm Hg after three readings while receiving treatment) | 15/19 | Algorithm and nurse led clinic (primary care) | Nurse clinic with 15 minute appointments compared with usual general practitioners’ 10 minute appointments, implementing common protocol. Blood pressure measured using random zero sphygmomanometer | Sequence generation unclear (not described), allocation concealment inadequate (not concealed), blinding inadequate (nurse and doctor not blinded) | Target diastolic blood pressure ≤90 mm Hg | 10/15 for intervention, 12/19 for control |
Jiang 2007,*33 Chengdu, China | Randomised controlled trial (six months) | Participants admitted to tertiary medical centres with angina or myocardial infarction | 83/84 | Community monitoring and ethnicity | 12 week home delivered cardiac rehabilitation programme based on American Heart Association 2000 secondary prevention guidelines setting goals for activity, diet, and blood pressure <140/90 mm Hg. Method of blood pressure measurement not described | Sequence generation adequate, allocation concealment adequate, blinding adequate | Systolic and diastolic blood pressure | Systolic: 129.8 (SD 12.1) mm Hg for intervention, 130.7 (SD 15.0) mm Hg for control. Diastolic: 78.3 (SD 8.6) mm Hg for intervention, 79.4 (SD 9.9) mm Hg for control |
Jolly 1999,*20 Southampton, England | Cluster randomised controlled trial; randomised at practice level (12 months) | Participants with diagnosis of angina or myocardial infarction in district general hospitals | 33/34 clusters, 277/320 participants | Nurse led clinic (primary care) | Structured follow-up by practice nurses, trained and given ongoing telephone support by specialist cardiac liaison nurses. Method of blood pressure measurement not described | Sequence generation adequate, allocation concealment adequate, blinding unclear (not clear if research nurse aware of allocation status) | Systolic and diastolic blood pressure and use of antihypertensive drugs | Systolic: 136.9 (SD 19) mm Hg for intervention, 19.1 (SD 21) mm Hg for control. Diastolic: 83.7 (SD 13) mm Hg for intervention, 85.0 (SD 14) mm Hg for control. Antihypertensive drugs: 210/262 for intervention, 230/297 for control |
Kastarinen 2002,41 eastern Finland | Open randomised controlled trial (two years) | Adults aged 25-74 with systolic blood pressure 140-179 mm Hg or diastolic 90-109 mm Hg or taking antihypertensive drugs | Group 1, 175/166; group 2, 185/189 | Nurse led clinic (primary care) | Visits to local public health nurses at 1, 3, 6, 9, 15, 18, and 21 months after randomisation, for systematic instruction in to change of individual health behaviours, with measurement of blood pressure and weight. Plus two group sessions at six and 18 months targeting reduction in salt intake and weight. Group 1: antihypertensive treatment compared with usual care. Group 2: no antihypertensive treatment compared with usual care. Blood pressure measured twice in right arm with mercury sphygmomanometer according to WHO MONICA protocol | Sequence generation adequate, allocation concealment inadequate, open allocation, blinding: inadequate (open study) | Reduction in systolic and diastolic blood pressure | Systolic: group 1, −6.0 (SD 17.3) mm Hg for intervention, −4.7 (SD 14.0) mm Hg for control; group 2, −2.0 (SD 11.5) mm Hg for intervention, 0.4 (SD 10.8) mm Hg for control. Diastolic: group 1, −3.8 (SD 8.7) mm Hg for intervention, −3.7 (SD 8.1) mm Hg for control; group 2, −2.4 (SD 6.7) mm Hg for intervention, −0.4 (SD 6.6) mm Hg for control |
Ko 2004,*46 Hong Kong | Randomised controlled trial (12 months) | People with type 2 diabetes and haemoglobin A1c >8%, recruited from three regional diabetes centres | 90/88 | Nurse led clinic (secondary care) and ethnicity | Thirty minute educational sessions delivered by diabetes education nurses directly after each physician appointment, with five visits per participant during study period. Method of blood pressure measurement not described | Sequence generation adequate, allocation concealment unclear (not described), blinding adequate | Systolic and diastolic blood pressure and use of antihypertensive drugs | Systolic: 139 (SD 21) mm Hg for intervention, 138 (SD 19) mm Hg for control. Diastolic: 76 (SD 11) mm Hg for intervention, 77 (SD 10) mm Hg for control. Antihypertensive drugs: 61/90 for intervention, 60/88 for control |
Lee 2007,*34 Taiwan, China | Randomised controlled trial (six months) | People aged ≥60 with known hypertension (defined as systolic blood pressure 140-179 mm Hg) | 91/93 | Community monitoring and ethnicity | Community based walking intervention delivered by public health nurse, with telephone and face to face support, to motivate frequency and time spent walking. Blood pressure measured three times with mercury sphygmomanometer as per National Committee on Detection, Evaluation, and Treatment of High Blood Pressure (fifth report) guidance | Sequence generation adequate, allocation concealment adequate, blinding adequate | Systolic and diastolic blood pressure and reduction in systolic and diastolic blood pressure | Systolic: 136.2 (SD 16.7) mm Hg for intervention, 143.6 (SD 15.3) mm Hg for control. Diastolic: 76.7 (SD 12.3) mm Hg for intervention, 75.7 (SD 11.6) mm Hg for control. Reduction in systolic: −15.4 (SD 9.5) mm Hg for intervention, −8.4 (SD 15.8) mm Hg for control. Reduction in diastolic: −6.5 (SD 9.5) mm Hg for intervention, −4.7 (SD 8.5) mm Hg for control |
Litaker 2003,47 Cleveland, Ohio, USA | Randomised controlled trial (12 months) | People with type 2 diabetes and established hypertension (defined as stage 1 or 2, JNC 1993 guidelines) recruited from tertiary centre | 79/78 | Algorithm, nurse led clinic (secondary care), and nurse prescribing | Nurse practitioner run clinics in hospital using treatment algorithms based on guidance from American Diabetes Association and for blood pressure, National Committee on Detection, Evaluation, and Treatment of High Blood Pressure (1997) and UKPDS (1998). Method of blood pressure measurement not described | Sequence generation unclear (not described), allocation concealment unclear (not described), blinding inadequate (participants and nurses not blinded) | Blood pressure target 130/85 mm Hg | 9/79 for intervention, 8/78 for control |
Logan 1979,35 Toronto, Canada | Randomised controlled trial (six months) | Participants aged 18-69 with diastolic blood pressure ≥95 or 90-94 mm Hg with systolic blood pressure >140 mm Hg not receiving treatment, selected from voluntary workplace based screening | 206/204 | Algorithm, community monitoring, and nurse prescribing | Nurses in workplace managed blood pressure according to structured protocol with treatment algorithm. Blood pressure measured three times after five minutes seated | Sequence generation unclear (not described), allocation concealment unclear (not described), blinding adequate | Diastolic blood pressure, reduction in diastolic blood pressure, blood pressure target (diastolic blood pressure <90 or >5 mm Hg fall if diastolic blood pressure ≤95 at entry), and use of antihypertensive drugs | Diastolic: 90.3 (SD 7.2) mm Hg for intervention, 94.3 (SD 8.6) mm Hg for control. Reduction in diastolic: −9.9 (SD 8.6) mm Hg for intervention, −6.1 (SD 8.6) mm Hg for control. Target blood pressure: 100/206 for intervention, 56/204 for control. Antihypertensive drugs: 177/206 for intervention, 108/204 for control |
McHugh 2001, 50 Glasgow, Scotland | Randomised controlled trial (mean eight months) | Patients added to coronary artery bypass waiting list | 49/49 | Nurse led clinic (primary care), community monitoring | Monthly health education sessions delivered alternately at home by cardiac liaison nurses and in general practices by practice nurses. Multiple risk factors addressed with behavioural change models and blood pressure assessed against Joint British Societies guidelines (1998) with reference to general practitioner if change to treatment needed. Mean of two blood pressure measurements recorded in accordance with British Heart Society guidelines | Sequence generation unclear (not described), allocation concealment unclear (not described), blinding inadequate (practices invited to deliver intervention) | Systolic and diastolic blood pressure and systolic blood pressure target <140 mm Hg | Systolic: 126.2 (SD 13.5) mm Hg for intervention, 138.9 (SD 16.5) mm Hg for control. Diastolic: 69.2 (SD 8.5) mm Hg for intervention, 74.6 (SD 10.7) mm Hg for control. Target blood pressure: 36/49 for intervention, 22/49 for control |
McLean 2008,36 Edmonton, Alberta, Canada | Randomised controlled trial (24 weeks) | Adults aged ≥18 with type 1 or type 2 diabetes and blood pressure >130/80 mm Hg at two visits two weeks apart | 115/112 | Community monitoring | Nurse and pharmacist teams at pharmacies delivered cardiovascular risk reduction education with documentation of blood pressure and support materials. Blood pressure readings and suggestions for change according to Canadian hypertension education programme guidelines faxed to primary care physician, and participants encouraged to see physician. Participants were seen by nurse-pharmacist team every six weeks. Blood pressure measured by Bp-Tru monitor (Coquitlam, Canada) as mean of five readings taken one minute apart | Sequence generation adequate, allocation concealment adequate, blinding inadequate (not blinded) | Reduction in systolic blood pressure, use of antihypertensive drugs, and blood pressure target <130/80 mm Hg | Reduction in systolic: −10.1 (SD 21.2) mm Hg for intervention, −5.0 (SD 21.9) mm Hg for control. Antihypertensive drugs: 76/115 for intervention, 81/112 for control. Blood pressure target: 54/115 for intervention, 37/112 for control |
Moher 2001,21 21 general practices in Warwickshire, England | Cluster randomised controlled trial; randomised at practice level (18 months) | Participants aged 55-75 with established coronary heart disease identified from practice records | 7/7 clusters, 665/559 participants | Algorithm, nurse led clinic (primary care) | Group 1: patients recalled to nurse clinic running agreed secondary prevention protocols. Nurses supported by nurse facilitator. Group 2: general practitioners agreed secondary prevention guidelines supported by investigator (not extracted), Group 3: usual care; practices received no further support after audit feedback. Method of blood pressure measurement not described | Sequence generation adequate, allocation concealment adequate, blinding inadequate (practices could not be blinded) | Use of antihypertensive drugs and blood pressure target <160/100 mm Hg | Antihypertensive drugs: 439/665 for intervention, 391/559 for control. Target blood pressure: 555/641 for intervention, 394/478 for control (group 1 intervention compared with group 3 usual care) |
Mundinger 2000*42 New York, USA | Randomised controlled trial (six months) | Hypertensive subgroup in study of nurse practitioner compared with physician run primary care clinics | 211/145 | Not included in meta-analyses | Allocation to usual nurse practitioner or usual family physician care. Method of blood pressure measurement not described | Sequence generation adequate, allocation concealment adequate, blinding unclear if nurses were blinded | Systolic and diastolic blood pressure | Systolic: 137 mm Hg for intervention, 139 mm Hg for control (no standard deviation reported). Diastolic: 82 mm Hg for intervention, 85 mm Hg for control (no standard deviation reported) |
New 2003*48 Salford, England | Randomised controlled trial (12 months) | People with diabetes recruited at annual hospital review, if blood pressure ≥140 or ≥80 mm Hg | 506/508 | Algorithm, nurse led clinic (secondary care), and nurse prescribing | Specialist nurse clinics attended every four to six weeks until target achieved; advice on lifestyle given, and treatment changes by protocol in accordance with British Heart Society 1999 guidelines. Blood pressure measured three times at one minute intervals with automated monitor (HEM-705CP Omron, Japan). Mean of last two readings recorded | Sequence generation adequate, allocation concealment adequate, blinding adequate | Reduction in systolic and diastolic blood pressure and blood pressure target <140/80 mm Hg | Reduction in systolic: −2.0 (SD 29.2) mm Hg for intervention, control not reported. Reduction in diastolic: −0.8 (SD 16.0) mm Hg for intervention, control not reported. Target blood pressure: 315/506 for intervention, 261/508 for control |
New 2004*22 Salford, England | Cluster randomised controlled trial; randomised at practice level (12 months) | People with diabetes and blood pressure >140/80 mm Hg | 2474/2531 | Algorithm and nurse led clinic (primary care) | Practice nurses and general practitioners visited by specialist diabetes care nurses, with support materials to refresh local diabetes protocols and targets, and list of patient poorly controlled at last annual review. Method of blood pressure measurement not described | Sequence generation adequate, allocation concealment adequate, blinding adequate | Reduction in systolic and diastolic blood pressure and blood pressure target <140/80 mm Hg | Reduction in systolic: −0.2 (SD 34.3 mm Hg for intervention, control not reported. Reduction in diastolic: −0.1 (SD 11.4) mm Hg for intervention, control not reported. Target blood pressure: 1192/2474 for intervention, 1212/2531 for control |
O’Hare 2004,23 West Midlands, England | Cluster randomised controlled trial; randomised at practice level (12 months) | South Asian people with type 2 diabetes and either raised blood pressure (>140 or >80 mm Hg) or haemoglobin A1c >7 or total cholesterol >5.0 | 3/3 cluster, 165/160 participants | Algorithm and nurse led clinic (primary care) | Enhanced care with Asian link workers, an additional practice nurse session per week, and community diabetic nurse support working to local protocols. Method of blood pressure measurement not described | Sequence generation adequate, allocation concealment adequate, blinding inadequate (practice not blinded) | Reduction in systolic and diastolic blood pressure and use of antihypertensive drugs | Reduction in systolic: −6.7 (SD 21.2) mm Hg for intervention, −2.1 (SD 17.5) mm Hg for control. Reduction in diastolic: −3.1 (SD 10.6) mm Hg for intervention, 0.3 (SD 10.0) mm Hg for control. Antihypertensive drugs: 56/165 for intervention, 40/160 for control |
Rudd 2004*30 Stanford, California, USA | Randomised controlled trial (six months) | Participants with mean blood pressure ≥150/95 mm Hg after two screening visits at least one week apart | 69/68 | Algorithm, telephone monitoring, and nurse prescribing | Nurse instructed participants in use of automated home blood pressure monitor, followed up with telephone calls at one week and one, two, and four months, and changed doses of drugs (or initiated new drug in consultation with physician) according to management algorithm based on National Committee on Detection, Evaluation, and Treatment of High Blood Pressure (sixth report) guideline. Blood pressure measured at home twice daily with automated monitor (UA 751, A&D Medical, San Jose, CA, USA), posted to nurse each fortnight | Sequence generation adequate, allocation concealment adequate, blinding adequate | Reduction in systolic and diastolic blood pressure and use of antihypertensive drugs | Reduction in systolic: −14.2 (SD 17.2) mm Hg for intervention, −5.7 (SD 18.7) mm Hg for control. Reduction in diastolic: −6.5 (SD 10.0) mm Hg for intervention, −3.4 (SD 8.0) mm Hg for control. Antihypertensive drugs: 66/69 for intervention, 53/68 for control |
Schroeder 200543 Bristol, England | Randomised controlled trial (six months) | Participants with uncontrolled hypertension defined as ≥150 or ≥90 mm Hg | 110/94 | Nurse led clinic (primary care) | Nurse delivered session on adherence support (20 minutes) with follow-up session (10 minutes) after two months. Method of blood pressure measurement not described | Sequence generation adequate, allocation concealment adequate, blinding inadequate (nurses not blinded) | Systolic and diastolic blood pressure | Systolic: 142.9 (SD 17.6) mm Hg for intervention, 147.7 (SD 20.9) mm Hg for control. Diastolic: 80.4 (SD 10.1) mm Hg for intervention, 79.9 (SD 9.7) mm Hg for control |
Taylor 200331 Santa Clara, California, USA | Randomised controlled trial (12 months) | People with diabetes aged ≥18, with haemoglobin A1c >10% and one of hypertension, dyslipidaemia, or cardiovascular disease | 61/66 | Algorithm, telephone monitoring, and nurse prescribing | 90 minute meeting with nurse to review care and develop self management programme, 1-2 hour group sessions weekly for four weeks, then follow-up telephone calls until 52 weeks. Nurse care managers used treatment algorithms for diabetic blood pressure and lipid treatment according to national guidelines (American Diabetes Association 2000). Blood pressure measured with a “standardised mercury sphygmomanometer and protocol” | Sequence generation unclear (not described), allocation concealment unclear (not described), blinding adequate | Systolic and diastolic blood pressure and blood pressure target <130 mm Hg systolic | Systolic: 130.9 (SD 14.8) mm Hg for intervention, 137.1 (SD 19.5) mm Hg for control. Diastolic: 75.5 (SD 10.9) mm Hg for intervention, 74.2 (SD 12.2) mm Hg for control. Target blood pressure: 32/61 for intervention, 28/66 for control |
Tobe 2006,37 Canada | Randomised controlled trial (12 months) | “First nations” American Indian people ≥aged 18 with type 2 diabetes and hypertension (blood pressure >130/80 mm Hg) | 48/47 | Algorithm, community monitoring, and nurse prescribing | Home care nurse delivered structured advice on lifestyle and nurse managed, changed drugs for hypertension according to local protocol, and encouraged adherence. Nurse follow-up appointments at six weeks and three, six, nine, and 12 months. Blood pressure measured with BpTRU (Coquitlam, Canada) automated oscillometric cuff after seated for 30 minutes | Sequence generation adequate, allocation concealment adequate, blinding inadequate (open study) | Reduction in systolic and diastolic blood pressure | Reduction in systolic: −24.0 (SD 13.5) mm Hg for intervention, −17.0 (SD 18.6) mm Hg for control. Reduction in diastolic: −11.6 (SD 10.6) mm Hg for intervention, −6.8 (SD 11.1) mm Hg for control |
Tonstad 2007,49 Oslo; Norway | Randomised controlled trial (six months) | Adults aged 30-69 with hypertension (systolic blood pressure 140-169 mm Hg and diastolic blood pressure 90-99 mm Hg) recruited from Oslo Health Study | 147/143 | Nurse led clinic (secondary care) | Initial 60 minute session and subsequent monthly 30 minute sessions with nurse promoting lifestyle behaviours according to individual risk profile, based on behavioural self management seven stages of change model. Blood pressure measured after five minutes seated | Sequence generation adequate, allocation concealment unclear (not described), blinding inadequate (nurse not blinded) | Systolic and diastolic blood pressure | Systolic: 147 (SD 9) mm Hg for intervention, 143 (SD 10) mm Hg for control. Diastolic: 91 (SD 8) mm Hg for intervention, 92 (SD 8) mm Hg for control |
Woollard 1995,28 Perth, Australia | Randomised controlled trial (18 weeks) | Treated hypertensive patients recruited in primary care | 52/46/48 | Telephone monitoring (group 1) and nurse led clinic (primary care) (group 2) | Group 1: single face to face 15 minute session discussing risk factors, supported by educational manual, followed by five 15 minute telephone counselling sessions. Group 2: as group 1 but given six 45 minute face to face sessions instead. Group 3: usual care. Blood pressure was mean of three measurements at three minute intervals after being seated for 10 minutes with automated monitor (DINAMAP 1846SX; GE Healthcare, UK) | Sequence generation unclear (not described), allocation concealment unclear (not described), blinding inadequate (nurse and participants not blinded) | Reduction in systolic and diastolic blood pressure | Reduction in systolic: group 1, −6.0 (SD 25.8) mm Hg; group 2, −8.0 (SD 31.1) mm Hg; group 3, −4.0 (SD 16.8) mm Hg. Reduction in diastolic: group 1, −1.0 (SD 10.9) mm Hg; group 2, −2.0 (SD 8.7) mm Hg; group 3, 1.0 (SD 8.8) mm Hg |
Woollard 2003 27 Perth, Australia | Randomised controlled trial with block randomisation (12 months) | Adults aged 20-75 with hypertension (defined as systolic >140 mm Hg or diastolic >90 mm Hg while receiving treatment), or with type 2 diabetes or coronary heart disease, recruited from general practices | 49/54/57 | Telephone monitoring (group 1) and nurse led clinic (primary care) (group 2) | Group 1: initial face to face session discussing risk factors, followed by monthly 10-15 minute telephone consultations for one year. Group 2: counselled in face to face monthly sessions lasting up to one hour, for one year. Group 3: usual care. Blood pressure measured with automated monitor (DINAMAP 1846 SX/P; GE Healthcare, UK) every two minutes for 10 minutes after resting seated for five minutes | Sequence generation unclear (not described), allocation concealment unclear (not described), blinding: adequate | Reduction in systolic and diastolic blood pressure and blood pressure target <130/85 mm Hg | Reduction in systolic: group 1, −0.9 (SD 11.5) mm Hg; group 2, −3.1 (SD 10.0) mm Hg; group 3, 0.2 (SD 15.9) mm Hg. Reduction in diastolic: group 1, −2.0 (SD 8.7) mm Hg; group 2, −1.8 (SD 8.7) mm Hg; group 3, −0.7 (SD 8.0) mm Hg. Target blood pressure: group 1, 26/49, group 2, 33/54, group 3, 24/57 |
WHO MONICA=World Health Organization Monitoring Trends and Determinants in Cardiovascular Disease ; UKPDS= United Kingdom Prospective Diabetes Study.
*Good quality studies.