Kraft 2012.
| Methods |
Parallel randomised controlled clinical trial Randomisation ratio: 1:1 Superiority design |
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| Participants | 26 participants; mean age 79.8 (SD 7.3) years; 10 male; 16 female Inclusion criteria: weight loss > 10% in previous 6 months; BMI < 21 kg/m2; albumin < 35g/L Exclusion criteria: malignancy, dementia, liver cirrhosis, dialysis‐dependent kidney insufficiency; insufficient cognitive ability; receiving professional care at home or living in a nursing home Diagnostic criteria: malnourished on discharge from hospital |
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| Interventions | Intervention group received an oral nutritional supplement and telemedicine monitoring comprising daily assessment of weight, compliance with supplement prescription and state of health. Responses triggered a range of nutritional management actions by a nurse employed by the tele‐medicine centre Number of trial centres: 1 Treatment before trial: not stated |
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| Outcomes | Outcomes reported in abstract of publication: weight and BMI | |
| Study details |
Run‐in period: none Was trial terminated early: no |
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| Publication details |
Language of publication: English Funding: non‐commercial and commercial funding ‐ Ministry of Social Affairs and Health, Western Pomerania, Germany and Nutricia (Germany) Publication status: peer review journal |
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| Stated aim for study | Quote from publication: "To evaluate the feasibility and explore the patients acceptance of the tele‐medical concept" | |
| Notes | ‐ | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk |
Quote from paper: "Patients were randomized consecutively into the intervention and control group" Comment: insufficient details of the method provided |
| Allocation concealment (selection bias) | Unclear risk | Comment: not described |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: not described |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: not described |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: high risk because of high attrition rate in the intervention group i.e. intervention (N = 13) 8 withdrew; control (N = 13) 3 withdrew; all withdrawals accounted for |
| Selective reporting (reporting bias) | Low risk | Comment: all outcome measures reported |
| Other bias | Low risk | Comment: baseline characteristics fully described; intervention and usual cares comparable |