|- candidate number||23391|
|- NTR Number||NTR5624|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||13-nov-2015|
|- Secondary IDs||NL54328.099.15 METC Leeuwarden|
|- Public Title||COPD coaching intervention Friesland|
|- Scientific Title||A coaching intervention to reduce re-hospitalization of severe COPD patients|
|- hypothesis||A coaching intervention reduces the re-hospitalization rate of severe COPD patients|
|- Healt Condition(s) or Problem(s) studied||COPD, Hospitalization|
|- Inclusion criteria||COPD patients (≥18 years) hospitalized because of an exacerbation who have had a previous hospitalization no longer than one year ago. |
|- Exclusion criteria||Subjects with COPD with predominant mental health problems
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-apr-2016|
|- planned closingdate||31-mrt-2019|
|- Target number of participants||120|
|- Interventions||One intervention will be implemented and studied, namely a coaching intervention. The coach’ main function will be to: educate the patient in order to stimulate self-management, monitor health status of the patient and facilitate coordination of care among different providers. |
|- Primary outcome||Re-hospitalization rate|
|- Secondary outcome||Type and number of treatments, both within and outside hospital, questionnaire outcomes (CCQ, SeMaS, SGRQ, MRC, HADS), 6 minutes walking test, medication use, co-morbidity, organizational barriers, purchasing practices.|
|- Timepoints||T0. Inclusion of patient. Analysis of patient medical record
T0-T+1 year. Multiple home coaching sessions, questionnaires, medical check-ups, make informal care plan
T+2 years. Final evaluation session by coach.
|- Trial web site||-|
|- status||recruitement status not public|
|- CONTACT FOR PUBLIC QUERIES|| Bart Noort|
|- CONTACT for SCIENTIFIC QUERIES|| Bart Noort|
|- Sponsor/Initiator ||Medisch Centrum Leeuwarden (MCL)|
(Source(s) of Monetary or Material Support)
|NWO, Medisch Centrum Leeuwarden, De Friesland Zorgverzekeraar|
|- Publications||A paper in a peer reviewed scientific healthcare (management) journal|
|- Brief summary||Rationale: Patients with severe COPD frequently get hospitalized because of too late recognition of severe symptoms, lack of coordinated and integrated care and few preventive activities aimed at health and social problems. Implementation of focused coaching activities may take away these flaws and thereby reduce re-hospitalizations.
Objective: This study aims to investigate the process and outcome of the implementation of a coaching intervention in COPD care in the Friesland province.
Study design: Before-and-after intervention study.
Study population: Intervention (coaching) group: COPD patients (≥18 years) hospitalized because of an exacerbation who have had a previous hospitalization.
Intervention (if applicable): The intervention group will receive coaching aimed at improving self-management and coordination of care.
Main study parameters/endpoints: Type and number of treatments, both within and outside hospital, time between hospitalizations, questionnaire outcomes (CCQ, SeMaS, SGRQ, MRC, HADS), 6 minutes walking test, medication use, co-morbidity, organizational barriers, purchasing practices.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will receive 7 home visits and 3 phone calls by the coach. During the coaching sessions patients will receive: feedback on health status, coaching on disease-management, training on medication use and multiple questionnaires will be filled in. In case of treatment by a physiotherapist, a six minutes walking test will be conducted twice.
For the questions related to the process and organization of the coach implementation, multiple stakeholders (medical professionals, insurer associates, care provider managers) will be interviewed. If relevant, also patients will be interviewed.
|- Main changes (audit trail)|
|- RECORD||13-nov-2015 - 27-feb-2016|