Telemedical Training for Chronically Ill COPD Patients: a Cross Sectoral Study

NCT02754232 | Withdrawn DMC

• 1 other identifier: TT2016
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Problem: Training is an important part of the treatment and rehabilitation of patients with chronic obstructive pulmonary disease (COPD) because training can increase the patient's muscle mass, lead to higher physical performance, reduce difficulties in breathing and hereby increase the patients' capacity to make use of the medical treatment. Rehabilitation is provided by hospitals training centres/outpatient clinics. However, the transport is too tiring for the patients, which is why they decline taking part in it. This can mean a worsening of their condition and an increase in readmissions. Solution:

• To develop a better treatment for patients with severe COPD: Telemedical training of patients with COPD in teams.
• To develop a cross-sectoral practice for the telemedical training patients will use, thus decreasing the readmissions of OUH's patients with severe COPD
• To optimize the patient's journey in and across sector borders by using Lean methods. Perspective: The study is expected to contribute to improving treatment of severely ill patients with COPD cross-sectorally. The results are expected to contribute to reducing readmissions and raising the level of evidence in telemedical research on training patients with severe COPD. The study's findings may be of use in relation to other patient groups who have difficulties coming to training. Background: This research project has its starting point in a pilot project. Its goal was to determine whether severely ill COPD patients could train at home and earlier than normal. Evaluation showed patients found it reassuring to train with the help of the COPD briefcase. They found it increased their physical and mental well-being. Method: To gain knowledge of the effect of telemedical training. The patient's strength, daily activity level and quality of life will be measured by conducting a randomized controlled trial including 125 patients - 62 in the intervention group and 62 in the control group. Qualitative research methods will be used to explore the user perspective concerning patients, family and health professionals. The method is critical psychological practice research. A Lean method consultant from University Hospital Odense (OUH) will be involved in developing the best clinical pathway for the patients and the professionals.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Physical training; Telemedicine; Daily activities; Cross sectoral

Outcome Measures

Primary Outcomes (1)

• The Stand up - sit down five times test (FTSST)

  The FTSST test (Stand up - sit down five times) is a function test, which measures lower body strength. It gives a picture of the ability to get up from a chair, which is a daily activity. The smallest relevant change is 2,7 seconds (Reuben and Siu, 1990). Whether patients continue rehabilitation training in the municipal sphere, after telemedical training is completed is also noted.

  7 weeks

Secondary Outcomes (7)

• The Clinical COPD Questionnaire (CCQ)

  3 and 7 weeks, 3 and 6 months

• The Activities of Daily Living Questionnaire (ADL - Q)

  7 weeks, 3 and 6 months

• Physical Activity Scale

  3 and 7 weeks, 3 and 6 months

• The Stand up - sit down five times test (FTSST)

  3 weeks, 3 and 6 months

• Readmissions

  3 and 6 months

Other Outcomes (3)

• Participation in municipial or private training

  3 and 7 weeks, 3 and 6 months

• The total cost of treatment compared with effectiveness

  7 weeks,3 and 6 months

• System Usability Scale (SUS)

  7 weeks

Study Arms (2)

Telemedical training

ACTIVE COMPARATOR

Patients in the intervention group will receive telemedical training 21 times, three times weekly for seven weeks. During the first three weeks the regional physiotherapists will be responsible for the training. Municipal occupational -and physiotherapists will manage the last four weeks' training.

Other: Telemedical training

The usual training or no training

NO INTERVENTION

Patients in the control-group will receive no telemedical training. They will be discharged to the municipal sphere with a rehabilitation plan, where they have the possibility to receive training.

Interventions

Telemedical training OTHER

Intervention will involve resistance training and anaerobic training

Telemedical training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with severe and very severe COPD, that is FEV1/FVC under 0,7, FEV1 under 50 % of the expected value and grade three and above on the Medical Research Council Dyspnoea Scale (MRC- Dyspnoea Scale).
• The patients have rejected OUH's offer of training at the hospital.
• The patients must be mobile enough to complete the training.
• The patients are motivated to participate in individual adjusted telemedical training in teams.
• The patients have at the same time been offered Telemedical consultations by a nurse
• The patients biggest problem concerning physical activity has to be their shortness of breath
• The patients live in either Svendborg or Odense

You may not qualify if:

• patients with lacking ability to communicate via telephone and/or computer screen, severe kidney insufficiency or cardiac insufficiency, saturation less than 88 % and possibly malignant changes in lung(s).

Sponsors & Collaborators

• Odense University Hospital: lead
• TREFOR: collaborator
• CoLab Denmark: collaborator
• Region of Southern Denmark: collaborator
• University of Southern Denmark: collaborator
• Danish Lung Association: collaborator

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kristian Kidholm, Ass professor

  University Hospital Odense

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.d. student

Study Record Dates

• First Submitted: April 21, 2016
• First Posted: April 28, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: August 26, 2016

Record last verified: 2016-08