10 Prescriptions an Hour. Group Treatment and Physical Activity Referral in a Primary Health Care Setting
10PAR
Randomized Controlled Trial of Group Treatment With Physical Activity Referral in a Primary Health Care Setting
1 other identifier
interventional
105
1 country
1
Brief Summary
The purpose of this study is to determine the effects of group treatment including physical activity referral (PAR) on level of physical activity and quality of life in patients diagnosed with type 2 diabetes and/or hypertension in a primary health care setting
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable type-2-diabetes
Started Mar 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
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 18, 2011
CompletedFirst Posted
Study publicly available on registry
May 20, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedNovember 27, 2012
October 1, 2012
1.3 years
May 18, 2011
November 23, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Physical activity level
Physical activity level is measured with an Actigraph GTM1/3. Overall physical activity, and total accumulated time and bouts of time in different categories of physical activity, will be determined according to count thresholds. Additonally subjective measurements of physical acidity are made using a questionnaire were questions about self-reported physical activity are reported (the International Physical Activity Questionnaire; IPAQ). Subjectively measured physical activity will be expressed as MET-minutes/week.
Up to 1 year
Secondary Outcomes (1)
Quality of life, measured using the EQ-5D questionnaire
1 year
Study Arms (2)
Group treatment and PAR
EXPERIMENTALUsual care
NO INTERVENTIONInterventions
Group treatment (8-12 patients per group) involving an empowerment-based process and the 5-A model and including PAR. Two group sessions, 6 months apart. The estimated total time for both group sessions together is 100 minutes.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of hypertension or type 2 diabetes since 10-09-2009 at St Hans Primary Health Care Center, Lund, Sweden
You may not qualify if:
- Dementia
- Psychosis
- Drug abuse
- Mental retardation
- Inability to walk without assistance
- Inability to speak Swedish
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Region Skanelead
Study Sites (1)
Center for Primary Health Care Research, Lund University/Region Skane
Malmo, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2011
First Posted
May 20, 2011
Study Start
March 1, 2011
Primary Completion
June 1, 2012
Study Completion
September 1, 2012
Last Updated
November 27, 2012
Record last verified: 2012-10