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. 2006 Oct 18;2006(4):CD004510. doi: 10.1002/14651858.CD004510.pub3

Tu 1993.

Methods DETAILS OF STUDY
AIM OF INTERVENTION: to increase self‐care knowledge, improve metabolic control and reduce self‐care behavioral deficits.
AIM OF STUDY: to determine the effect of telephone follow‐up on diabetes self‐care knowledge, blood glucose levels, and changes in self‐care behaviors of the elderly subjects.
STUDY DESIGN: CCT.
METHODS OF RECRUITMENT OF PARTICIPANTS: a convenience sample was recruited from inpatients of a diabetic hospital.
INCLUSION CRITERIA FOR PARTICIPATION IN STUDY: 60 years and older/ diabetes mellitus 2/ successfully completed an inpatient diabetes education program during their hospitalisation/ intact cognitive functioning/ able to perform self‐care activities independently/ are being followed by primary physician in the diabetes clinic.
EXCLUSION CRITERIA FOR PARTICIPATION IN STUDY: complex medical conditions (heart failure, end‐stage renal disease, advanced cancer, major surgery,..).
INFORMED CONSENT OBTAINED? yes.
ETHICAL APPROVAL? yes.
FUNDING: yes.
ASSESSMENT OF STUDY QUALITY
ALLOCATION CONCEALMENT: unclear.
EPOC‐ QUALITY CRITERIA 2002: C.high risk of bias.
METHOD OF GENERATING RANDOMISATION SCHEDULE: not specified.
METHOD OF CONCEALMENT OF ALLOCATION: not specified.
BLINDING: 
 ·PARTICIPANTS: no. 
 ·PROVIDER/S: no. 
 ·OUTCOME ASSESSOR/S: no.
INTENTION TO TREAT ANALYSIS: not stated.
BASELINE COMPARABILITY OF INTERVENTION AND CONTROL GROUPS: not stated.
STATISTICAL METHODS AND THEIR APPROPRIATENESS: t‐test/chi‐square.
CONSUMER INVOLVEMENT: not stated.
Participants DESCRIPTION: diabetes patients.
GEOGRAPHIC LOCATION: USA.
SETTING: discharged home from an acute care setting.
NUMBER OF PARTICIPANTS: 
 ELIGIBLE: 36. 
 RANDOMISED TO INTERVENTION: 16. 
 RANDOMISED TO CONTROL: 12. 
 INCLUDED IN ANALYSIS INTERVENTION GROUP: 15. 
 INCLUDED IN ANALYSIS CONTROL GROUP: 12.
AGE: RANGE OR MEAN (SD): 65 (6.5).
GENDER (% MALE): 33.
ETHNICITY: 52% white.
PRINCIPAL HEALTH PROBLEM OR DIAGNOSIS: diabetes 2.
OTHER HEALTH PROBLEM/S: not specified.
TREATMENT RECEIVED/RECEIVING: education program.
OTHER SOCIAL/DEMOGRAPHIC DETAILS: 63% had 12 years of education.
Interventions DETAILS OF INTERVENTION: subjects in the experimental group were contacted by either the primary investigator or a trained research assistant (both nurses) within 24 to 48 hours after discharge from hospital. The telephone calls were repeated at weekly intervals for 3 weeks, thus a total of 4 calls were made. Each call consisted of assessing the diabetic client's self care knowledge and practice of self‐care activities or behaviours; supplemental instructions were provided when indicated.
DETAILS OF CONTROL: usual care.
CO‐INTERVENTION? no.
DETAILS OF CO‐INTERVENTIONS:
DELIVERY OF INTERVENTION 
 Frequency: 4. 
 First time at day 1‐2 after discharge. 
 Period: 4.
PROVIDERS: nurse.
INTERVENTION QUALITY: unclear.
FIDELITY/INTEGRITY: good.
Outcomes NUMBER OF OUTCOMES: 3
OUTCOME / TOOL / TOOL VALIDATED / METHOD OF ASSESSMENT / TIME OF ASSESSMENT 
 A.Psycho‐social health of patients (uncertainty, anxiety, informational needs, mood, coping, quality of life, social activity, ..):
B.Physical health of patients (eg. functional status, self‐care, self‐efficacy, independence, ..): Selfcare deficits / self‐developed / no / telephone interview / 6 weeks after discharge. Blood glucose level / Hba1c‐level / unclear / blood sample / 3 months after discharge.
C.Other consumer oriented outcomes (eg. treatment adherence, knowledge, adverse events, ..): Knowledge / Diabetes knowledge scale (Dunn,1984) / yes / telephone interview / 6 weeks after discharge.
D. Health service delivery oriented outcomes (eg. hospital readmission, health services utilization, ..):
Notes ·CHANGES IN TRIAL PROTOCOL
·CONTACT WITH AUTHOR
·POWER CALCULATION?
·RECORD IF THE STUDY WAS TRANSLATED FROM A LANGUAGE OTHER THAN ENGLISH.
·RECORD IF THE STUDY WAS A DUPLICATE PUBLICATION.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Unclear risk B ‐ Unclear