Developing care pathways for remote monitoring

Not Applicable

Completed

• Conditions: Topic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular; Circulatory System; Heart failure

• Registration Number: ISRCTN47114929
• Lead Sponsor: Southampton University Hospitals NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-23
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

All participants:
1. Be on stable medical therapy for 6 weeks prior to recruitment
2. Have the ability to independently comprehend and complete QOL Questionnaires
3. Have an episode of New York Heart Association (NHYA) class III heart failure
4. Be on optimal medical therapy
5. Male and female, lower age limit of 16 years

Group 2 additional criteria:
6. Must be implanted with a Medtronic Device that has the optivol feature
7. Have had a cardiac device implanted for at least 3 months prior to recruitment
8. Will have had no device related complications

Exclusion Criteria

1. If unable to use the technology due to mental or physical limitations
2. Less than 16 years old
3. Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of Life is measured uisng the Living with Heart failure Minnesota Life Score and 36-item short form health survey (SF-36) at baseline, 1, 3 and 6 months

Secondary Outcome Measures

Name	Time	Method
o secondary outcome measures