| Popis: |
Background: A feasibility study was conducted to implement the TIPPS intervention for pregnant women to enhance infant birthweight in a conflict area in a LMIC. The decision tool, ADePT examines the methodological factors, identified in a feasibility study, that may require modification for a full trial. Objectives: To use the ADePT decision tool to evaluate if the feasibility study had achieved its objectives and to identify the need for intervention, clinical context and trial design modification.Basic research design: Feasibility study: a one-arm, pre-test-post-test design. The ADePT framework was applied to evaluate the findings from the feasibility study.Clinical setting: Primary healthcare clinic located in Gaza City, Palestine. Participants: 25 pregnant women in their first trimester and clinic staff.Interventions: The TIPPS periodontal health intervention delivered by ante-natal nurses.Main outcome measures: ADePT checklist: sample size estimation, recruitment, consent, intervention adherence, intervention acceptability, costs and duration, completion and appropriateness of outcome assessments, retention, logistics and synergy between protocol components.Results: 25 pregnant women attended the baseline and 22 completed the second follow-up appointment. Data acquisition of the primary and secondary outcomes was mainly successful, the adherence and acceptability of the intervention was noted. The participants stated the value of the intervention. The clinic staff voiced concerns regarding time and costs of nurses providing the TIPPS intervention. This allowed suggestions to be made regarding modification of trial design and context of implementation. Conclusions: The ADePT evaluation showed it was possible to progress to full trial with modifications in trial design. |
