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DOI 10.1186/s13063-015-0628-y

Медицинская библиотека · Trials · 2015

Mixed methods feasibility study for a trial of blood pressure telemonitoring for people who have had stroke/transient ischaemic attack (TIA).

Hanley Janet, Fairbrother Peter, Krishan Ashma, McCloughan Lucy, Padfield Paul, Paterson Mary, Pinnock Hilary, Sheikh Aziz, Sudlow Cathie, Todd Allison, McKinstry Brian

Клиническое исследование I фазыКлиническое исследование II фазыСтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАПеревод пока не подготовлен

Аннотация

BACKGROUND

Good blood pressure (BP) control reduces the risk of recurrence of stroke/transient ischaemic attack (TIA). Although there is strong evidence that BP telemonitoring helps achieve good control, none of the major trials have considered the effectiveness in stroke/TIA survivors. We therefore conducted a feasibility study for a trial of BP telemonitoring for stroke/TIA survivors with uncontrolled BP in primary care.

METHOD: Phase 1 was a pilot trial involving 55 patients stratified by stroke/TIA randomised 3:1 to BP telemonitoring for 6 months or usual care. Phase 2 was a qualitative evaluation and comprised semi-structured interviews with 16 trial participants who received telemonitoring and 3 focus groups with 23 members of stroke support groups and 7 carers.

RESULTS

Overall, 125 patients (60 stroke patients, 65 TIA patients) were approached and 55 (44%) patients were randomised including 27 stroke patients and 28 TIA patients. Fifty-two participants (95%) attended the 6-month follow-up appointment, but one declined the second daytime ambulatory blood pressure monitoring (ABPM) measurement resulting in a 93% completion rate for ABPM - the proposed primary outcome measure for a full trial. Adherence to telemonitoring was good; of the 40 participants who were telemonitoring, 38 continued to provide readings throughout the 6 months. There was a mean reduction of 10.1 mmHg in systolic ABPM in the telemonitoring group compared with 3.8 mmHg in the control group, which suggested the potential for a substantial effect from telemonitoring. Our qualitative analysis found that many stroke patients were concerned about their BP and telemonitoring increased their engagement, was easy, convenient and reassuring.

CONCLUSIONS

A full-scale trial is feasible, likely to recruit well and have good rates of compliance and follow-up.

TRIAL REGISTRATION: ISRCTN61528726 15/12/2011.

Для цитирования: Hanley Janet, Fairbrother Peter, Krishan Ashma, McCloughan Lucy, Padfield Paul, Paterson Mary, Pinnock Hilary, Sheikh Aziz, Sudlow Cathie, Todd Allison, McKinstry Brian. Mixed methods feasibility study for a trial of blood pressure telemonitoring for people who have had stroke/transient ischaemic attack (TIA).. Trials. 2015. DOI: 10.1186/s13063-015-0628-y.

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