Physical Activity Advice in Diabetics at Annual Review
PAADAR
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
1 other identifier
interventional
80
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes
Started Jun 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2011
CompletedFirst Posted
Study publicly available on registry
May 10, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedMay 10, 2011
May 1, 2011
1.5 years
May 9, 2011
May 9, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
SPAQ score
Increased Physical Activity
12 months
Study Arms (2)
Exercise advice
EXPERIMENTALBehavioural
Normal Care
OTHERNormal care
Interventions
Eligibility Criteria
You may qualify if:
- Adult Type 2 diabetics
You may not qualify if:
- non ambulatory
- within 6 months diagnosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ship Street Surgery
East Grinstead, Sussex, Rh19 4EA, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jerry D Hill, MRCGP
National Health Service, United Kingdom
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 9, 2011
First Posted
May 10, 2011
Study Start
June 1, 2011
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
May 10, 2011
Record last verified: 2011-05