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

Primary Purpose

Type 2 Diabetes, Hypertension

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Group treatment and PAR
Sponsored by
Region Skane
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Group treatment, Physical activity referral, Type 2 diabetes, Hypertension

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group treatment and PAR

Usual care

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 18, 2011
Last Updated
November 23, 2012
Sponsor
Region Skane
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1. Study Identification

Unique Protocol Identification Number
NCT01357304
Brief Title
10 Prescriptions an Hour. Group Treatment and Physical Activity Referral in a Primary Health Care Setting
Acronym
10PAR
Official Title
Randomized Controlled Trial of Group Treatment With Physical Activity Referral in a Primary Health Care Setting
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Skane

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Hypertension
Keywords
Group treatment, Physical activity referral, Type 2 diabetes, Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group treatment and PAR
Arm Type
Experimental
Arm Title
Usual care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Group treatment and PAR
Intervention Description
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.
Primary Outcome Measure Information:
Title
Physical activity level
Description
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.
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
Quality of life, measured using the EQ-5D questionnaire
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Center for Primary Health Care Research, Lund University/Region Skane
City
Malmö
Country
Sweden

12. IPD Sharing Statement

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