Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Feasibility & Effect of a Tele-rehabilitation Program for Chronic Obstructive Pulmonary Disease vs. Standard Rehabilitation
Brief Summary: Introduction In order to guarantee chronic patients and elderly a high quality service from health care organizations in the coming decades, new technologies have been implemented to treat patients from a distance. There is still a need for more studies on the efficacy and cost-effectiveness of tele-rehabilitation (TR) and its long-term effects needs also to be determined. To guarantee individuals with chronic obstructive pulmonary diseases (COPD) a high quality service from health care organizations in the coming decades and economically save the national health systems for an expensive bill for the treatment of COPD, new actions plans has to be taken into use. Hereby, more patients can be treated with less human resources while still sustaining or even improving today's services. The importance of such welfare action plans has to maintain a high quality of service that individuals with COPD are willing to accept. Here, TR seems to be a good welfare action plans. Despite proof of improved cost-effectiveness, no studies support the benefits of TR in COPD patient with respect to adherence, security, treatment efficacy and improved quality of life.

Aim To assess and compare the feasibility and effect of a tele-rehabilitation program with a new and innovative TR platform (NITRP) compared to standard treatment with respect to exercise capacity, quality of life and activities of daily living in patients with COPD.

Method and material The study is a prospective randomized controlled trial comparing the effects of tele-rehabilitation and conventional rehabilitation in patients with severe COPD. 54 patients fulfilling the inclusion criteria will be randomized in two groups to either a 8 week tele-rehabilitation program or a conventional COPD rehabilitation program at the hospital. Participants will be tested at baseline, 8 weeks, 3 and 6 months after cessation of the training programs. In the intervention group, a real- and a virtual physiotherapist agent will facilitate the rehabilitation.

Ethical considerations This study will not pose any risk to the patient as compared to current practice. Participation is voluntary and the patient may at any time withdraw from the study without consequences for future care or treatment. The questionnaires and the test methods used are clinically recognized instruments. Signed informed consent will be obtained from the all participants after verbal and written information and before the study starts. The study will not be initiated before approval from the Ethics Committee and the Data Protection Agency has been obtained. The study will follow the general research ethical rules as expressed in the Helsinki Declaration II.


Options:
A: Arm Label: Disease management program; Type: EXPERIMENTAL; Interventions: Other: Disease Management | Arm Label: Usual site management; Type: ACTIVE_COMPARATOR; Interventions: Other: Usual site management | Intervention Type: OTHER; Name: Disease Management; Assigned to Arm(s): Disease management program | Intervention Type: OTHER; Name: Usual site management; Assigned to Arm(s): Usual site management
B: Arm Label: Outreach visits; Type: EXPERIMENTAL; Interventions: Behavioral: Outreach visits | Arm Label: Control (late intervention); Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Outreach visits; Assigned to Arm(s): Outreach visits
C: Arm Label: control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: adherence to guideline; Type: OTHER; Interventions: Other: Implementation educational programme | Intervention Type: OTHER; Name: Implementation educational programme; Assigned to Arm(s): adherence to guideline
D: Arm Label: Intervention group "tele-rehabilitation"; Type: EXPERIMENTAL; Interventions: Combination Product: Tele Rehab | Arm Label: Control; Type: ACTIVE_COMPARATOR; Interventions: Combination Product: Tele Rehab | Intervention Type: COMBINATION_PRODUCT; Name: Tele Rehab; Assigned to Arm(s): Control, Intervention group "tele-rehabilitation"

Answer: D