Condition category
Nutritional, Metabolic, Endocrine
Date applied
14/08/2005
Date assigned
26/08/2005
Last edited
14/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.cnpq.br

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

Publication citations

Additional files

Editorial Notes