Primary care practice based care management for chronically ill patients
| ISRCTN | ISRCTN56104508 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56104508 |
| Secondary identifying numbers | 190/09 |
- 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
Scientific
University Hospital Heidelberg
Department of General Practice and Health Services Research
Voßstrasse 2
Heidelberg
69115
Germany
Study information
| Study design | Open multicentre cluster randomised controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient 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 | 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 study start date | 01/10/2010 |
| Completion date | 31/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
69115
Germany
Sponsor information
University Hospital Heidelberg (Germany)
Hospital/treatment centre
Hospital/treatment centre
Im Neuenheimer Feld 672
Heidelberg
69120
Germany
| Website | http://www.klinikum.uni-heidelberg.de/ |
|---|---|
"ROR" |
https://ror.org/013czdx64 |
Funders
Funder type
Government
General Local Health Insurance (Allgemeine Ortskrankenkasse [AOK]) Baden-Wuerttemberg (Germany)
No information available
General Local Health Insurance (Allgemeine Ortskrankenkasse [AOK]) Bundesverband (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 29/06/2011 | Yes | No | |
| Results article | results | 01/03/2016 | Yes | No |
Editorial Notes
04/02/2016: Publication reference added.
