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Clinical Trial
. 2013 Oct;13(10):2672-84.
doi: 10.1111/ajt.12393. Epub 2013 Aug 7.

Preventive intervention for living donor psychosocial outcomes: feasibility and efficacy in a randomized controlled trial

Affiliations
Clinical Trial

Preventive intervention for living donor psychosocial outcomes: feasibility and efficacy in a randomized controlled trial

M A Dew et al. Am J Transplant. 2013 Oct.

Abstract

There are no evidence-based interventions to prevent adverse psychosocial consequences after living donation. We conducted a single-site randomized controlled trial to examine the postdonation impact of a preventive intervention utilizing motivational interviewing (MI) to target a major risk factor for poor psychosocial outcomes, residual ambivalence (i.e. lingering hesitation and uncertainty) about donating. Of 184 prospective kidney or liver donors, 131 screened positive for ambivalence; 113 were randomized to (a) the MI intervention, (b) an active comparison condition (health education) or (c) standard care only before donation. Ambivalence was reassessed postintervention (before donation). Primary trial outcomes-psychosocial variables in somatic, psychological and family interpersonal relationship domains-were assessed at 6 weeks and 3 months postdonation. MI subjects showed the greatest decline in ambivalence (p = 0.050). On somatic outcomes, by 3 months postdonation MI subjects reported fewer physical symptoms (p = 0.038), lower rates of fatigue (p = 0.021) and pain (p = 0.016), shorter recovery times (p = 0.041) and fewer unexpected medical problems (p = 0.023). Among psychological and interpersonal outcomes, they had a lower rate of anxiety symptoms (p = 0.046) and fewer unexpected family-related problems (p = 0.045). They did not differ on depression, feelings about donation or family relationship quality. The findings suggest that the intervention merits testing in a larger, multisite trial.

Trial registration: ClinicalTrials.gov NCT01233700.

Keywords: Ambivalence; kidney donor; liver donor; living donor; psychosocial outcomes.

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Figures

Figure 1
Figure 1
Study procedures timeline.a aThe postdonation assessment timepoints in this initial efficacy study were selected for several reasons. The 6-week point was selected in order to begin to track donor outcomes after they had recovered from the immediate effects of surgery. Donors were followed through 3 months because other studies document negative psychosocial outcomes within this time frame.(10,11)
Figure 2
Figure 2
Study flowchart.
Figure 3
Figure 3
Effects of MI intervention on somatic outcomes domain at 6 weeks and 3 months postdonation. Each F compares MI subjects to all other subjects. F from linear model for continuous variables (effect size, d); F from general linear model with logit link function for dichotomous variables (effect size, odds ratio, OR). formula image MI formula image Enhanced Standard Care formula image Standard Care Only
Figure 4
Figure 4
Effects of MI intervention on psychological outcomes domain at 6 weeks and 3 months postdonation. Each F compares MI subjects to all other subjects. F from general linear model with logit link function for these dichotomous variables (effect size, odds ratio, OR). formula image MI formula image Enhanced Standard Care formula image Standard Care Only
Figure 5
Figure 5
Effects of MI intervention on family relationship domain at 6 weeks and 3 months postdonation. Each F compares MI subjects to all other subjects. F from linear model for continuous variable (effect size, d); F from general linear model with logit link function for dichotomous variables (effect size, odds ratio, OR). formula image MI formula image Enhanced Standard Care formula image Standard Care Only

References

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