Outpatient cardiac rehabilitation, Part VI: Scientific monitoring of the Multi-centre, prospective cohort study with two control groups (with/without phase III)

Research area: Rehabilitation and occupational therapy

Duration: September 2012 – June 2016
Publication: LBI-HTA Project report No. 90: https://eprints.aihta.at/1101/

Additional team: Heinz Tüchler
Language: German

Background:
Six- to twelve-month outpatient cardiac phase III rehabilitation following phase II is currently provided at a few sites in Austria. Eight outpatient cardiac rehabilitation centres of the working group on outpatient cardiac prevention and rehabilitation (AGAKAR) currently have temporary contracts with the Association of Austrian Health Insurance Providers. Phase III rehabilitation aims at preventing a decline of positive effects achieved in phase II (positive impact on cardiovascular risk factors) or even at a further improvement.

Research question:
The ongoing study is based upon numerous preliminary work of LBI-HTA (outpatient cardiac rehabilitation parts I to IV). The study protocol (part V) is online available as decision support document no. 50.1 The primary research question of the study is: Do patients with disadvantageous risk profile (at least three out of six risk factor categories out of the rehabilitation target area) who attend an additional phase III program after phase II (+PhIII) have at mean less risk factors out of the target area compared to patients without phase III (-PhIII) 18 months after end of phase II?

Activities:
Within project part V LBI-HTA was responsible for the preparation of the study protocol, the compilation of the questionnaires and the first submission to the ethics committees.  Moreover, we visited all participating inpatient rehabilitation centres to inform them about the planned study. In addition to the study protocol1 we prepared a handbook for patient recruitement2, which has also been published on LBI-HTAs document server.
Until the final data analysis and the preparation of the project report, which will be performed after the end of the study (2015), the Association of Austrian Health Insurance Providers (HVB) provides human/ financial resources for the study administration office and the data management.

LBI-HTA is responsible for:
• annual extension of the ethics committees´ votes,
• notification of ethics committees about potential protocol revisions,
• answering questions from participating centres (via study administration office) about patient recruitment
• continuous communication via email and as required by meetings with HVB
• repeated data quality checks on demand
• written feedback and oral presentation about T0 data when required
• development of the data evaluation scheme
There will be no interim analysis of results.

Time schedule:
Sept. 2012: start of patient recruitment
March 2013: first quality check of preliminary T0 data
April 2013: first prolongation ethics committee´s vote
Sept. 2013: second quality check of preliminary T0 data
April 2014: second prolongation ethics committee´s vote, end of patient recruitment
June 2014: start of quality check of complete T0 data
Nov. 2014: first quality check of preliminary T1 data
April 2015: third prolongation ethics committee´s vote
June 2015: end of observation period
July 2015: start of quality check of complete T1 data
Aug.-Oct. 2015: data analysis
Sept.-Nov. 2015: drafting of the report
Dec. 2015: internal and external review, layout

References:
1Piso, B. und Tüchler, H. (2012): Outpatient cardiac rehabilitation. Part V: Study protocol "Multi-centre, prospective cohort study with two control groups (with/without phase III)". Decision Support Document 50. Available at https://eprints.aihta.at/971/
2Piso, B. und Tüchler, H. (2012): Patient recruitement manual „Multi-centre, prospective cohort study with two control groups (with/without phase III)". Available at https://eprints.aihta.at/971/