Trial Outcomes & Findings for Health Literacy in Patients With Congestive Heart Failure (NCT NCT00508716)
NCT ID: NCT00508716
Last Updated: 2015-04-15
Results Overview
Number of participants who are re-hospitalized or die within 90 days of discharge
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
124 participants
Primary outcome timeframe
90 days
Results posted on
2015-04-15
Participant Flow
Recruited from inpatients at a small community Hospital March 1, 2007-July 31 2010.
Participant milestones
| Measure |
Usual Care
Usual Care - Education about CHF by Primary Nurse on discharge. No teach-back is used in this arm.
|
Tailored Low Health Literacy Intervention
Tailored Intervention for patients with low health literacy and nurse-directed teachback: Educational leaflet which has been developed for low-health literacy patients. Adminstered by dedicated Nurse-educator. Nurse-educator asks Patient for "teachback after Intervention". This means that the Patient repeats in his/her own words the Information received. Education ends once Patient has been able to repeat the Information back.
Health Literacy-Tailored Education: Intervention group receives a visit from a nurse educator who, using the teach back method of educating patients, provides counseling on their disease methods of controlling their disease. A video is also viewed to reinforce the materials.
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
63
|
|
Overall Study
COMPLETED
|
61
|
63
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Health Literacy in Patients With Congestive Heart Failure
Baseline characteristics by cohort
| Measure |
Usual Care
n=61 Participants
CHF Education by usual Nurse without teach-back or Video.
|
Tailored Intervention for Patients With Low Health Literacy an
n=63 Participants
Tailored Intervention for patients with low health literacy and nurse-directed teachback
Health Literacy-Tailored Education: Intervention group receives a visit from a nurse educator who, using the teach back method of educating patients, provides counseling on their disease methods of controlling their disease. A video is also viewed to reinforce the materials.
|
Total
n=124 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
44 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
61 participants
n=5 Participants
|
63 participants
n=7 Participants
|
124 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 90 daysNumber of participants who are re-hospitalized or die within 90 days of discharge
Outcome measures
| Measure |
Usual Care
n=61 Participants
Usual Care - Education about CHF by Primary Nurse on discharge. No teach-back is used in this arm.
|
Tailored Low Health Literacy Intervention
n=63 Participants
Tailored Intervention for patients with low health literacy and nurse-directed teachback: Educational leaflet which has been developed for low-health literacy patients. Adminstered by dedicated Nurse-educator. Nurse-educator asks Patient for "teachback after Intervention". This means that the Patient repeats in his/her own words the Information received. Education ends once Patient has been able to repeat the Information back.
Health Literacy-Tailored Education: Intervention group receives a visit from a nurse educator who, using the teach back method of educating patients, provides counseling on their disease methods of controlling their disease. A video is also viewed to reinforce the materials.
|
|---|---|---|
|
Re-hospitalization or Death
|
48 participants
|
48 participants
|
Adverse Events
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Teilored Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place