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. |
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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. |
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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. |
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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, ..): |
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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. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |