Randomised Trial of Telehealth Consultations for Nursing Care of Chronic Obstructive Pulmonary Disease (COPD) Patients

NCT01178879 | Completed

• 1 other identifier: UNRS-20100030-2
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether telehealth nursing consultations of chronic obstructive pulmonary disease (COPD) patients are superior to hospital readmissions.

Conditions

COPD

Keywords

Telehealth; nurse consultation; outpatient clinic

Outcome Measures

Primary Outcomes (1)

• The number of readmissions

  at 26 weeks after discharge

Secondary Outcomes (5)

• The mortality rate

  at 26 weeks weeks after discharge

• The duration to the first readmission

  at 26 weeks after discharge

• The number of hospital readmissions with exacerbation

  at 26 weeks after discharge

• The number of days readmitted

  days 26 weeks after discharge

• The number of days readmitted with exacerbation

  days 26 weeks after discharge

Study Arms (2)

Telehealth consultation

EXPERIMENTAL

Telehealth nurse consultation plus treatment as usual

Behavioral: Telehealth consultation

Conventional

NO INTERVENTION

Treatment as usual

Interventions

Telehealth consultation BEHAVIORAL

The consultations are structured as outpatient sessions immediately after discharge. The content of the education deals with the regular treatment, prevention of exacerbation and how to live with the illness. The aim of the counseling is to increase the patient's empowerment and competence to take action. The patients have the consultations for 7 days followed by a telephone call. Each session is organized and individualised according to the patient's wishes and needs for education and counselling. The equipment consists of a computer with web camera, microphone and measurement equipment. A button to contact to the nurse at the hospital, an alarm button and a volume button. The results are transferred to the hospital by a secure internet line.

Also known as: Telehealth nurse consultation

Telehealth consultation

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic obstructive pulmonary disease (COPD) verified by spirometry.
• Exacerbation in COPD, defined as increased need for medicine, and increased dyspnea or increased expectorate or increased coughing.
• \> or 40 years old
• Living on Funen and islands
• Signed informed consent.

You may not qualify if:

• Not able to communicate via telephone and/or computer screen
• Previously received "The COPD suitcase", or participated in this protocol
• Systolic BT is \<100 mm Hg
• Saturation \< 90
• Thorax x-ray shows signs of malignant changes or lobar pneumonia
• Diagnosed with cancer or recurrence of cancer within the last five years
• Admitted with septic shock, acute myocardial infarction or other serious medical condition (for example renal disease)
• Diagnosed with heart failure (EF \< 30%)
• Refused to participate

Sponsors & Collaborators

• University of Southern Denmark: lead
• Odense University Hospital: collaborator
• Sygekassernes Helsefond: collaborator
• Danish Nurses Organisation: collaborator

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (5)

• Murray CJ, Lopez AD. Alternative projections of mortality and disability by cause 1990-2020: Global Burden of Disease Study. Lancet. 1997 May 24;349(9064):1498-504. doi: 10.1016/S0140-6736(96)07492-2.

  PMID: 9167458 BACKGROUND

• (2) Sundhedsstyrelsen. Genindlæggelser af ældre i Danmark 2008 - Nye tal fra Sundhedsstyrelsen. 1060. Ref Type: Internet Communication.

  BACKGROUND

• Eriksen N, Hansen EF, Munch EP, Rasmussen FV, Vestbo J. [Chronic obstructive pulmonary disease. Admission, course and prognosis]. Ugeskr Laeger. 2003 Sep 8;165(37):3499-502. Danish.

  PMID: 14531348 BACKGROUND

• Casas A, Troosters T, Garcia-Aymerich J, Roca J, Hernandez C, Alonso A, del Pozo F, de Toledo P, Anto JM, Rodriguez-Roisin R, Decramer M; members of the CHRONIC Project. Integrated care prevents hospitalisations for exacerbations in COPD patients. Eur Respir J. 2006 Jul;28(1):123-30. doi: 10.1183/09031936.06.00063205. Epub 2006 Apr 12.

  PMID: 16611656 BACKGROUND

• Finkelstein SM, Speedie SM, Potthoff S. Home telehealth improves clinical outcomes at lower cost for home healthcare. Telemed J E Health. 2006 Apr;12(2):128-36. doi: 10.1089/tmj.2006.12.128.

  PMID: 16620167 BACKGROUND

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

• Anne Dichmann Sorknaes, PhD student

  University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: August 9, 2010
• First Posted: August 10, 2010
• Study Start: May 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: June 28, 2013

Record last verified: 2013-06

Locations

DK (1)