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10 Prescriptions an Hour. Group Treatment and Physical Activity Referral in a Primary Health Care Setting (10PAR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Region Skane
ClinicalTrials.gov Identifier:
NCT01357304
First received: May 18, 2011
Last updated: November 23, 2012
Last verified: October 2012
History of Changes
  Purpose

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


Condition Intervention
Type 2 Diabetes
Hypertension
 Behavioral: Group treatment and PAR

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Group Treatment With Physical Activity Referral in a Primary Health Care Setting

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Region Skane:

Primary Outcome Measures:
  • Physical activity level [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Quality of life, measured using the EQ-5D questionnaire [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    EQ-5D, a validated instrument that classifies health according to five items (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), each of which has three alternatives ("no problem", "moderate problem" and "severe problem"). Combining the answers gives an index with a score of between 0.59 and 1.0.


Enrollment: 105
Study Start Date: March 2011
Study Completion Date: September 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group treatment and PAR Behavioral: Group treatment and PAR
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.
No Intervention: Usual care

Detailed Description:

A sedentary lifestyle and low levels of physical activity in populations are major health problems today and contribute substantially to poor health and diseases such as type 2 diabetes and hypertension. An increased and systematic effort to increase physical activity in the Swedish population in general, and in patients with type 2 diabetes/hypertension in particular, is important. Written prescriptions of physical activity with follow-up (i.e., PAR), is a cost-efficient way to increase physical activity in individuals.

The aim of this trial is to study whether physical activity is increased by a group method involving PARs in patients with hypertension and/or type 2 diabetes compared with a control group that receives usual care in the same primary care setting. Follow-up will be performed at 6 and 12 months.

This trial is being conducted to determine whether it is possible to offer PARs to more patients in a way that requires less effort and resources. The intervention in this study requires 10 minutes of a health care worker's time per patient during a 6-month period. Each patient requires 100 minutes with an instructor who oversees the group intervention.

Group treatment is given 3 weeks after baseline and at 6 months. Follow-up at 12 months involves data collection, but no intervention.

An empowerment process, with the 5-A-model as framework, will be used in the clinical intervention.

All participants will be required to fill in questionnaires and wear an ActiGraph GTM1/GTM3 for 7 days at baseline and at 6 and 12 months.

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of hypertension or type 2 diabetes since 10-09-2009 at St Hans Primary Health Care Center, Lund, Sweden

Exclusion criteria:

  • Dementia
  • Psychosis
  • Drug abuse
  • Mental retardation
  • Inability to walk without assistance
  • Inability to speak Swedish
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01357304

Locations
Sweden
Center for Primary Health Care Research, Lund University/Region Skane
Malmö, Sweden
Sponsors and Collaborators
Region Skane
  More Information

No publications provided

Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT01357304     History of Changes
Other Study ID Numbers: Dnr 2011/95
Study First Received: May 18, 2011
Last Updated: November 23, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Region Skane:
Group treatment
Physical activity referral
Type 2 diabetes
Hypertension

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypertension
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013