Primary care practice based care management for chronically ill patients

ISRCTN	ISRCTN56104508
DOI	https://doi.org/10.1186/ISRCTN56104508
Protocol serial number	190/09
Sponsor	University Hospital Heidelberg (Germany)
Funders	General Local Health Insurance (Allgemeine Ortskrankenkasse [AOK]) Baden-Wuerttemberg (Germany), General Local Health Insurance (Allgemeine Ortskrankenkasse [AOK]) Bundesverband (Germany)

Submission date: 20/10/2010
Registration date: 24/11/2010
Last edited: 04/02/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Joachim Szecsenyi
Scientific

University Hospital Heidelberg
Department of General Practice and Health Services Research
Voßstrasse 2
Heidelberg
69115
Germany

Study information

Primary study design	Interventional
Study design	Open multicentre cluster randomised controlled clinical trial
Secondary study design	Cluster randomised trial
Study type	Participant information sheet
Scientific title	Primary care practice based care management for chronically ill patients: An open multicentre cluster randomised controlled trial
Study acronym	PraCMan
Study objectives	Primary care practice based care management reduces the number of all-cause hospitalisations in a population of chronically ill patients at high risk for future hospitalisation. The intervention will improve patients' quality of life, self-management and clinical status.
Ethics approval(s)	1. The Ethical Commitee of the University Hospital Heidelberg, 30/07/2010, ref: S-232/2010 2. The Ethical Committee of the Federal Medical Association Baden-Wuerttemberg, 31/08/2010, ref: B-F-2010-043
Health condition(s) or problem(s) studied	Chronic disease management; Type 2 diabetes mellitus; Chronic obstructive pulmonary disease; Chronic heart failure and comorbid conditions
Intervention	Care management delivered by teams of primary care physicians and trained health care assistants compared to usual care. Care management consists of comprehensive assessment of medical and non-medical needs, individualised care planning and goal setting, self-management support and care coordination and regular telephone monitoring of symptoms and self-management. The intervention period is 12 months.
Intervention type	Other
Primary outcome measure(s)	Number of all-cause hospitalisations within 12 months of intervention/control
Key secondary outcome measure(s)	1. Health related quality of life (SF-12, EQ5D) 2. Medication adherence 3. Self-management 4. Patient reported delivery of chronic care elements (PACIC) 5. Health care costs 6. Contacts with specialists/generalists and supportive services 7. Mortality 8. Clinical status 9. Depression All outcomes will be assessed at 12 and 24 months.
Completion date	31/12/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	2700
Key inclusion criteria	1. Adults (18 years+) with any of the following index conditions and a high predicted likelihood of hospitalisation based on insurance claims data analysis: 1.1. Type 2 diabetes 1.2. Chronic obstructive pulmonary disease 1.3. Chronic heart failure 2. Beneficiaries of a GP-centred care contract of the General Regional Health Fund (AOK) 3. Listed in one of the participating practices
Key exclusion criteria	1. Active cancer disease (under ongoing radio- or chemotherapy) 2. Undergoing dialysis 3. Moderate to severe dementia 4. Concurrent participation in other clinical trials 5. Living in nursing homes 6. Physical, mental or other conditions that hinder active participaton in the trial
Date of first enrolment	01/10/2010
Date of final enrolment	31/12/2012

Locations

Countries of recruitment

Germany

Study participating centre

University Hospital Heidelberg

Heidelberg
69115
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2016		Yes	No
Protocol article	protocol	29/06/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

04/02/2016: Publication reference added.