Blixen 2001.
Methods | An open, prospective, randomised controlled study evaluating the use of an asthma education program specifically targeted for African Americans compared with no education (control group). | |
Participants |
Inclusion criteria: African‐American adults aged between 18 to 50 years hospitalised overnight at a single hospital with a primary diagnosis of asthma Exclusion criteria: No information described Participants were identified and approached whilst hospitalised with an asthma episode. Verbal consent was obtained from those who wished to participate. A face‐to‐face baseline interview was arranged (whilst still hospitalised). Following baseline interview, participants were randomly assigned to either the intervention or control group. Telephone interviews were conducted at 3 and 6 months consisting of the same questions asked at baseline plus additional information about any asthma events since the last interview. Number approached: n = 40 Number declined: n = 12 Number consented and randomised: n = 28 (n = 14 intervention group and n = 14 control group) Baseline: Intervention group n = 14, Control group n = 14 3 month follow‐up: Intervention group n = 10, Control group n = 11 6 month follow‐up: Intervention group n = 7, Control group n = 6 |
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Interventions |
Recruitment dates: July to November 1997 Sample size: n = 30 (15 per arm) Intervention group: received three one‐hour individual asthma self‐management educational sessions with a nurse educator while hospitalised with a primary diagnosis of asthma. The aim of the sessions was to teach patients the rationale and skills required to manage asthma as a chronic inflammatory process rather than an episodic crisis‐driven process. During these educational sessions, participants received a number of resources as outlined. 1. Workbook (Learn Asthma Control in Seven Days) which was modified to be culturally appropriate to African Americans. This included a discussion on handling the stressors common to many African Americans. The goals of the educational intervention were to;
To achieve these goals a video on MDI technique and peak flow monitoring was shown during the educational sessions. The video featured a well‐known African‐American asthma researcher (Dr Marvella Ford). Participants rehearsed the demonstration until appropriate technique was mastered, and which included:
2. Participants were shown a video on MDI‐technique and peak flow monitoring. The video, "Managing Your Asthma: Understanding Proper Inhaler and Peak Flow Technique" was produced by Glaxo‐Wellcome and featured an African‐American asthma specialist showing African‐American patients how to use MDIs and Peak flow meters. Participants then rehearsed the demonstration until the technique was mastered. Participants were given the video, a peak flowmeter and a spacer for an MDI to take home. Written materials to reinforce the concepts and self‐management techniques introduced in the educational sessions were mailed to the intervention group participants at 3 and 6 months. Control group: were asked to continue with their usual care and follow‐up, which represented the 'generic' asthma programme. |
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Outcomes |
Outcome measures
Outcome assessments were performed by telephone interview at three and six months post intervention. |
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Notes |
Lost to follow‐up at final assessment: n = 15 Funding: The Nursing Research Program‐Clinical Applications Research‐GlaxoWellcome and The Agency for Health Care Policy and Research |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of randomisation was not described by authors |
Allocation concealment (selection bias) | Unclear risk | Study authors did not describe method of allocation concealment and how this was maintained |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding of participants was not possible after randomisation, given the nature of the intervention compared to the control group |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The randomisation status of participants at 3 and 6 months interviews were concealed by using a different trained interviewer who did not participate in the education program and was not aware of randomisation status |
Incomplete outcome data (attrition bias) All outcomes | High risk | Attrition was high, with only 13/28 (46%) participants able to be contacted for the 6‐month post discharge follow‐up interview due to disconnected phone or moving without a forwarding address |
Selective reporting (reporting bias) | Low risk | Descriptive data reported. Intention‐to‐treat analysis not used |
Other bias | Unclear risk | Education intervention aimed to optimise anti‐inflammatory therapy by improving metered dose inhalation and peak flow ‐ data not reported in paper |