A Case Control Study to Assess the Effectiveness of Written Advice to Increase Physical Activity Given to Type II Diabetics by Nursing Staff During the Diabetic Annual Review in UK General Practice

Study Objectives

The objectives of this study are to evaluate whether incorporating a simple low-cost, low resource intervention into routine diabetic care in General Practice is effective in producing a sustained change in activity levels across significant numbers of patients. Even if the change in activity level is small on an individual patient level but is widespread across the practice's diabetic population then the intervention will be of value. The primary outcome will be measured using a validated self reporting questionnaire (SPAQ-Scottish Physical Activity Questionnaire) to measure changes in the amount of exercise undertaken. During routine diabetic care a wide range of information is recorded on the clinical system in part to satisfy QoF (Quality and Outcomes Framework) requirements it will be possible to further analyse the dataset by parameters such as age, sex and social class as well as seeing whether there is a change in blood pressure, weight, lipid profile and HbA1C (glycosylated haemoglobin- a measure of medium term diabetic control). The intervention is simple and if effective could form part of the routine ongoing care of Type II Diabetics. If extended over a longer period it might be possible to extract data relating the intervention to illness and death rates.

The delivery of an intervention, from a known Health Care Professional in a familiar setting, at an interview where the patient's expectation is to receive advice and hopefully therefore be receptive to that advice, with regular reinforcement as part of routine care may mean that the initial intervention can be straight forward. This study seeks to answer this question by deliberately choosing written information which was in an unsuccessful arm of a previous study ~ the Time2Act study.

The original study design was to record baseline activity levels in the target population with an appropriate assessment tool, carry the intervention and then record any changes in activity levels and biometric and biochemical parameters at intervals . This could have been considered as an audit and part of 'normal care' and therefore some investigators might argue that formal patient consent was not required. However following discussions with the team at Queen Mary's University of London (QMUL) this would weaken the study as it would be difficult to assess the effects of any confounding factors. The presence of a control group would make the study more valid. A randomized controlled trial (RCT) would have been the ideal design but constraints of time and outcomes measured by a questionnaire would have required a larger than practical study of long duration. A Case Control study was therefore chosen and will act as a pilot for follow up work.

Inclusion and Exclusion Criteria