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

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

Study Overview

• Status: Completed
• Conditions: Hypertension; Type 2 Diabetes
• Intervention / Treatment: Behavioral: Group treatment and PAR

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.

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Malmö, Sweden
    • Center for Primary Health Care Research, Lund University/Region Skane

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life, measured using the EQ-5D questionnaire	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.	1 year

Collaborators and Investigators

• Sponsor: Region Skane

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: May 18, 2011
• First Submitted That Met QC Criteria: May 19, 2011
• First Posted (Estimate): May 20, 2011

Study Record Updates

• Last Update Posted (Estimate): November 27, 2012
• Last Update Submitted That Met QC Criteria: November 23, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Hypertension; Type 2 diabetes; Group treatment; Physical activity referral
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hypertension; Diabetes Mellitus, Type 2
• Other Study ID Numbers: Dnr 2011/95