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Completed

NCT Number: NCT00705302

Patient Education in Patients With Chronic Obstructive Pulmonary Disease (COPD) - Effect and Costs

The aim of this study is to determine the long term effect of a self-help group in a patient education program for patients with chronic obstructive pulmonary disease (COPD).

Completed

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Public Health and General Practice, Norwegian University of Science and Technology

Trondheim, N-7491, Norway

About this study

Pulmonary rehabilitation is aimed to increase the level of health of patients with COPD by increasing their self care ability. A recent updated systematic review concluded that evidence strongly supports respiratory rehabilitation as part of the spectrum of management of patients with chronic obstructive pulmonary disease (COPD). Studies of pulmonary rehabilitation programs lasting up to 18 months show that effects are mainly maintained throughout the duration of the program. The long term effect, however, is mostly studied for programs of shorter durations. Some of the studies with shorter duration have found that the achieved benefit was lost or diminished during the follow up period, while others have found that the effect has been maintained up to 18 months. Our necessity in the rehabilitative field is to find strategies to maintain benefits during time.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • (FEV1) lower that 75% of predicted
  • the ability to participate in physical activity
  • not been hospitalized the last month.

Exclusion criteria

  • contraindications for physical activity

Treatment and study plan

Group training with self-help group

Behavioral

Combined educational and exercise program for pulmonary rehabilitation, with (1) or without(2 a self-help group. The educational part consists firstly of two days with group meetings with information from medical doctor, pharmacist, psychologist, ergonomist, nurse, social worker, physiotherapist and a clinical nutritional physiologist. One more day will be held after 3 months and it is the participants themselves who decide on the content of these days. An experienced patient will participate throughout the course. The exercise part consists of group training twice a week for 3 months with 10-15 participants in each group. Patients will instead of five of the group training sessions, participate in a self-help group.

Group training

Behavioral

Combined educational and exercise program for pulmonary rehabilitation. The educational part consists firstly of two days with group meetings with information from medical doctor, pharmacist, psychologist, ergonomist, nurse, social worker, physiotherapist and a clinical nutritional physiologist. One more day will be held after 3 months and it is the participants themselves who decide on the content of these days. An experienced patient will participate throughout the course. The exercise part consists of group training twice a week for 3 months with 10-15 participants in each group.

Primary outcomes

  1. St. George's Respiratory Questionnaire (SGRQ) - Total score

    Time frame: Baseline, 3, 6 and 12 months

Secondary outcomes

  1. Modified Borg scale (MBS) pre, during and post 6MWT

    Time frame: Baseline, 3, 6 and 12 months

  2. Patient Activation Measure (PAM)

    Time frame: Baseline, 3, 6 and 12 months

  3. The Perceived Quality of Life Scale

    Time frame: Baseline, 3, 6 and 12 months

  4. 6 minute walk test (6MWT)

    Time frame: Baseline, 3, 6 and 12 months

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Registry information

Official study title

A Randomised Controlled Trial of the Effect of a Patient Education Program for Patients With Chronic Obstructive Pulmonary Disease (COPD)

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Jun 26, 2008
Registry last updated
Feb 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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