Physical Activity Advice in Diabetics at Annual Review (PAADAR)
Recruitment status was Not yet recruiting
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Purpose
Type II diabetes is an important condition with a UK prevalence of 3.54% affecting approximately 2.5 million people across the country. Diabetics have a fivefold increased risk of cardiovascular disease and over 65% of diabetics will die from coronary heart disease or stroke. Exercise is one of the management tools along with medication and weight reduction available to improve diabetic control reducing morbidity and mortality. Exercise promotion might be more effective at a population level if it could be incorporated in a simple form as part of pre-existing routine care. This case control study seeks to assess the effectiveness of written exercise advice given to Type II diabetics at the time of their annual review. The study will be open to all Type II diabetics in a single general practice attending their routine nurse led annual review. The intervention uses leaflets prepared as part of a previous study the Time2Act study and assessment will be by self-reported questionnaires. Follow up will be over 12 months but the study design will allow for longer durations. Previous studies have demonstrated the effectiveness of exercise as an intervention but have often been hospital-based and used exercise interviews as the main intervention rather than incorporating exercise advice into structures already established in routine Primary Care. If this study demonstrates that a simple intervention carried out as part of routine care has a positive effect if only at a low level then disseminating this knowledge across the country would bring significant benefits to Type II diabetics.
| Condition | Intervention |
|---|---|
|
Diabetes |
Behavioral: Leaflet Behavioral: Exercise Advice Behavioral: Normal Care |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | 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 |
- SPAQ score [ Time Frame: 12 months ] [ Designated as safety issue: No ]Increased Physical Activity
| Estimated Enrollment: | 80 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Exercise advice
Behavioural
|
Behavioral: Leaflet
Advice Leaflet
Behavioral: Exercise Advice
Leaflet
|
|
Normal Care
Normal care
|
Behavioral: Normal Care
Normal Care
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult Type 2 diabetics
Exclusion Criteria:
- non ambulatory
- within 6 months diagnosis
Contacts and Locations| United Kingdom | |
| Ship Street Surgery | Not yet recruiting |
| East Grinstead, Sussex, United Kingdom, Rh19 4EA | |
| Principal Investigator: Jerry D Hill | |
| Principal Investigator: | Jerry D Hill, MRCGP | National Health Service, United Kingdom |
More Information
No publications provided
| Responsible Party: | Dr J D HILL, Ship Street Surgery |
| ClinicalTrials.gov Identifier: | NCT01351181 History of Changes |
| Other Study ID Numbers: | 007489 |
| Study First Received: | May 9, 2011 |
| Last Updated: | May 9, 2011 |
| Health Authority: | United Kingdom: National Health Service |
Keywords provided by Ship Street Surgery:
|
Diabetes |
Additional relevant MeSH terms:
|
Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013