Contact information
Type
Scientific
Primary contact
Dr Ricardo Kuchenbecker
ORCID ID
Contact details
Rua Landel de Moura
1369
Porto Alegre
91920-150
Brazil
+55 51 3268 8919
rkuchen@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
02-066
Study information
Scientific title
Acronym
SDDM
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
Hospital unexpected readmissions and emergency department visits
Secondary outcome measures
Quality of life, length of stay, morbidity, mortality, healthcare costs, glycated hemoglobin, total cholesterol, aspirin use, statin use, hypoglicemic episodes
Overall trial start date
01/03/2003
Overall trial end date
01/03/2006
Reason abandoned
Eligibility
Participant inclusion criteria
>40 and <75 years old, clinical diagnosis of type 2 diabetes and ischemic heart disease
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
316
Participant 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
Recruitment start date
01/03/2003
Recruitment end date
01/03/2006
Locations
Countries of recruitment
Brazil
Trial participating centre
Rua Landel de Moura, 1369
Porto Alegre
91920-150
Brazil
Sponsor information
Organisation
National Council for Scientific and Technological Development (CNPq) (Brazil)
Sponsor details
SEPN 507
Bloco
Brasilia
70740-901
Brazil
+55 61 21089000
comunicacao@cnpq.br
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
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).
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