NCT02085187

Brief Summary

Chronic obstructive pulmonary disease (COPD) is a widespread disease that can have a major impact on the lives of individuals. An essential element in the treatment of COPD is rehabilitation of which supervised training is an important part. However, not all individuals with severe COPD can participate in the rehabilitation provided by hospitals and municipal training centres due to distance to the training venues and transportation difficulties. The aim of the feasibility study was to evaluate an individualised home based training and counselling programme via video conference to patients with severe COPD after hospitalization with regard to safety, clinical outcomes, patients' perception, organisational aspects and economic aspects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 12, 2014

Completed
Last Updated

March 12, 2014

Status Verified

March 1, 2014

Enrollment Period

11 months

First QC Date

March 6, 2014

Last Update Submit

March 10, 2014

Conditions

Keywords

Pulmonary rehabilitationTrainingCounsellingTelemedicineVideoconferenceCOPDChronic diseaseInternet.

Outcome Measures

Primary Outcomes (9)

  • Clinical COPD Questionnaire (CCQ)

    A self-administered validated questionnaire measuring the health status of patients with COPD.

    Up to 3 weeks

  • Timed Up & Go test (TUG)

    Measuring the time in seconds (with 2 decimals), it takes a person to rise from an ordinary chair (with back and armrest), walk 3 meters, turn around and walk back to the chair and sit down again

    Up to 3 weeks

  • The five time sit to stand test (FTSST)

    Measures functional lower limb muscle strength, where the time in seconds (2 decimals) used for 5 times rising from a chair is measured.

    Up to 3 weeks

  • Patients' falls during training

    Up to 3 weeks

  • Need for acute contact to the general practitioner

    Up to 3 weeks

  • Patient subjective perception

    The patients submitted a postcard with information about their experience. The postcard was an open ended question and was printed with the text "Dear Department of rehabilitation. My experience of training and counselling by use of the Patient briefcase was … ".

    Up to 3 weeks

  • Costs per patient participating in the telemedicine rehabilitation

    This included renting of the "patient briefcase", establishing of a safe line for data transmission and use of hospital staff.

    Up to 3 weeks

  • Reimbursement to the hospital

    Estimated as the DRG (Diagnose Related Groups) value of the rehabilitation activity similar to the payment for the activity from the regional health system (The Region of Southern Denmark) to the hospital in accordance with health care financing system).

    Up to 3 weeks

  • Focus Group interview

    The perception of the hospital staff of the telemedicine intervention programme was assessed by a focus group interview with the occupational- and physiotherapists who carried out the telemedicine rehabilitation training and thus were familiar with the programme.

    Up to 3 weeks

Study Arms (1)

Telemedicine training and counselling

EXPERIMENTAL
Other: Telemedicine training and counselling

Interventions

Training and counselling by the physiotherapist consisted of 3 weekly sessions, lasting 30-45 minutes, over a 3 week period, i.e. a total of 9 supervised sessions. Heart rate and oxygen saturation were monitored during the exercise training. This included thoracic mobilization exercises, cardio training, strength training and breathing exercises. The training intensity was progressed continuously. There were 1-2 sessions with the occupational therapist, which consisted of training and counselling on energy conservation techniques. The first session was 60 minutes long and included assessment, counselling and training. This session was delivered in the second week of the intervention. The intervention concluded in the third week, with sessions of 30 minutes as required.

Telemedicine training and counselling

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • severe and very severe COPD (i.e. with an FEV1 (forced expiratory volume in 1 second) value under 50% of the predicted value, an FEV1/FVC (forced vital capacity) ratio \< 70%, MRC (Medical Research Council Dyspnoea Scale) grade 3)
  • ≥40 years
  • hospitalization with exacerbation of COPD
  • declined participation in the hospital based rehabilitation
  • participation in videoconference sessions with a nurse for one week immediately after discharge.

You may not qualify if:

  • inability to communicate via telephone and computer
  • systolic BP \<100mm Hg
  • X-rays of the thorax showing abnormalities suspicious of thoracic malignancy or lobar pneumonia
  • a diagnosis of cancer or recurrence of cancer within the last 5 years
  • hospitalization with septic shock, acute myocardial infarction (AMI) or other serious medical conditions (e.g. kidney disorder)
  • heart failure (EF\<30%)
  • if the patient did not wish to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (2)

  • Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.

  • Rosenbek Minet L, Hansen LW, Pedersen CD, Titlestad IL, Christensen JK, Kidholm K, Rayce K, Bowes A, Mollegard L. Early telemedicine training and counselling after hospitalization in patients with severe chronic obstructive pulmonary disease: a feasibility study. BMC Med Inform Decis Mak. 2015 Feb 7;15:3. doi: 10.1186/s12911-014-0124-4.

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveChronic Disease

Interventions

Counseling

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Lilian Møllegård, Reg. Nurce

    Odense University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistent Professor

Study Record Dates

First Submitted

March 6, 2014

First Posted

March 12, 2014

Study Start

January 1, 2012

Primary Completion

December 1, 2012

Study Completion

January 1, 2013

Last Updated

March 12, 2014

Record last verified: 2014-03

Locations