Condition category
Not Applicable
Date applied
20/10/2010
Date assigned
24/11/2010
Last edited
04/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.pracman.org

Contact information

Type

Scientific

Primary contact

Prof Joachim Szecsenyi

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

190/09

Study information

Scientific title

Primary care practice based care management for chronically ill patients: An open multicentre cluster randomised controlled trial

Acronym

PraCMan

Study hypothesis

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

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

Study design

Open multicentre cluster randomised controlled clinical trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

Number of all-cause hospitalisations within 12 months of intervention/control

Secondary outcome measures

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.

Overall trial start date

01/10/2010

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

2700

Participant 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

Recruitment start date

01/10/2010

Recruitment end date

31/12/2012

Locations

Countries of recruitment

Germany

Trial participating centre

University Hospital Heidelberg
Heidelberg
69115
Germany

Sponsor information

Organisation

University Hospital Heidelberg (Germany)

Sponsor details

Im Neuenheimer Feld 672
Heidelberg
69120
Germany

Sponsor type

Hospital/treatment centre

Website

http://www.klinikum.uni-heidelberg.de/

Funders

Funder type

Government

Funder name

General Local Health Insurance (Allgemeine Ortskrankenkasse [AOK]) Baden-Wuerttemberg (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

General Local Health Insurance (Allgemeine Ortskrankenkasse [AOK]) Bundesverband (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21714883
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26833209

Publication citations

  1. Protocol

    Freund T, Peters-Klimm F, Rochon J, Mahler C, Gensichen J, Erler A, Beyer M, Baldauf A, Gerlach FM, Szecsenyi J, Primary care practice-based care management for chronically ill patients (PraCMan): study protocol for a cluster randomized controlled trial [ISRCTN56104508]., Trials, 2011, 12, 163, doi: 10.1186/1745-6215-12-163.

  2. Results

    Freund T, Peters-Klimm F, Boyd CM, Mahler C, Gensichen J, Erler A, Beyer M, Gondan M, Rochon J, Gerlach FM, Szecsenyi J, Medical Assistant-Based Care Management for High-Risk Patients in Small Primary Care Practices: A Cluster Randomized Clinical Trial, Ann Intern Med, 2016 , doi: 10.7326/M14-2403.

Additional files

Editorial Notes

04/02/2016: Publication reference added.