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. 2023 May 31;2023(5):CD014513. doi: 10.1002/14651858.CD014513

Tu 1993.

Study characteristics
Methods Diabetes self‐care knowledge, behaviors, and metabolic control of older adults‐‐the effect of a post educational follow‐up program
RCT (NA clusters and NA providers), conducted in 1) Patients were recruited from inpatients of a diabetic hospital in a southeastern health sciences centre, Birmingham, Alabama. Follow‐up intervention via telephone. 2) Telephone made by the primary investigator or a trained research assistant. Instructions on reportable symptoms were emphasised and referrals were made when indicated (e.g. calling the dietitian for additional help with dietary regime). In United States of America.
2 arms: 1. Control (usual care: inpatient education programme) (control arm) and 2. Intervention (inpatient education programme and telephone follow‐up) (intervention arm)
Participants Control arm N: 15
Intervention arm N: 16, NA, NA
Diabetes type: 2
Mean age: 65.44 ± 11.65
% Male: 33.33
Longest follow‐up: 3 months
Interventions Control arm: (usual care: in patient education programme)
Intervention arm: (in patient education programme and telephone follow‐up)
1) Case management
2) Patient education
3) Promotion of self‐management
Outcomes Glycated haemoglobin
Harms
Funding source This study was supported by the Dean’s new investigator research award in geriatric nursing, School of Nursing, University of Alabama at Birmingham, Birmingham, Alabama
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Method not reported. The participants were randomly assigned to an experimental group (EG) or a control group (CG).
Allocation concealment (selection bias) Unclear risk Not reported.
Patient's baseline characteristics (selection bias) Low risk Table 1. Data reported. No P values but in text: there was no significant difference in demographic and disease‐related variables between the two groups.
Patient's baseline outcomes (selection bias) Unclear risk No outcome data are reported at baseline.
Incomplete outcome data (attrition bias) High risk They lost 3/15 (20%) patients in the control group and 1/16 (6%) patients in the intervention group. During the course of the study, 1 participant in the experimental group and 3 participants in the control group developed major medical conditions and were unable to complete the study. Thus, the final sample included 27 participants. Unbalanced numbers of lost and high number in the control group.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Unclear risk HbA1c was objectively measured. Hypoglycaemia was self‐reported by patients. Unlikely that patients were blinded. Quote: "If insulin reactions (hypoglycaemia) had occurred, data were obtained regarding the frequency, time, and the relationship of the reaction to meals, snacks, and/or activity level. Measures for preventing hypoglycaemic reactions were reviewed with the participants."
Selective reporting (reporting bias) Unclear risk No registered or published protocol. No baseline data for HbA1c and hypoglycaemia. Results match methods for other outcomes.
Risk of contamination (other bias) Low risk Patient RCT. Unlikely that control patients received follow‐up calls. The only phone call made to participants in the control group was to administer the DKN test and to assess behavioural deficits during the week of the posttest.
Other bias Low risk None identified.