Structured discharge planning for patients with diabetes mellitus type 2 and ischemic heart disease: a randomised controlled trial
| ISRCTN | ISRCTN33576922 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33576922 |
| Protocol serial number | 02-066 |
| Sponsor | National Council for Scientific and Technological Development (CNPq) (Brazil) |
| Funder | The National Council for Scientific and Technological Development (CNPq). CNPq is a foundation linked to the Brazilian Ministry of Science and Technology (MCT), that supports Brazilian research (Brazil). |
- Submission date
- 14/08/2005
- Registration date
- 26/08/2005
- Last edited
- 14/09/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Ricardo Kuchenbecker
Scientific
Scientific
Rua Landel de Moura, 1369
Porto Alegre
91920-150
Brazil
| Phone | +55 51 3268 8919 |
|---|---|
| rkuchen@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | SDDM |
| Study objectives | Inpatients with diabetes mellitus type 2 and ischemic heart disease that receive structured discharge plans have less frequent hospital unexpected readmissions comparing to patients that receive usual care |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Diabetes mellitus type 2 and ischemic heart disease (simultaneously) |
| Intervention | Structured discharge plan (educational intervention) delivered by trained nurses versus usual care |
| Intervention type | Other |
| Primary outcome measure(s) |
Hospital unexpected readmissions and emergency department visits |
| Key secondary outcome measure(s) |
Quality of life, length of stay, morbidity, mortality, healthcare costs, glycated hemoglobin, total cholesterol, aspirin use, statin use, hypoglicemic episodes |
| Completion date | 01/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 316 |
| Key inclusion criteria | >40 and <75 years old, clinical diagnosis of type 2 diabetes and ischemic heart disease |
| Key exclusion criteria | Homeless individuals, hospitalization for <48 hours, severe mental disease, pregnant, transplantation recipients, survival expected time <2 years due to non-cardiac illnesses, chronic renal failure with dialitic treatment |
| Date of first enrolment | 01/03/2003 |
| Date of final enrolment | 01/03/2006 |
Locations
Countries of recruitment
- Brazil
Study participating centre
Rua Landel de Moura, 1369
Porto Alegre
91920-150
Brazil
91920-150
Brazil
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |