| Objective:Through the systematic evaluation and analysis of the non-pharmacological interventions for post stroke fatigue(PSF).Construction of the comprehensive intervention program of PSF during acute phase based on the theory of symptom management,so as to improve the fatigue severity,self-efficacy and quality of life of patients.Methods:Part 1:Construction of intervention program for post-stroke fatigue during acute phase.Through the previous cross-sectional study on the incidence and factors of PSF during acute phase and the systematic evaluation and analysis of risk factors for PSF based on the research group,based on the literature retrieval and systematic evaluation of non-drug intervention measures of PSF,the first draft of intervention plan was developed combined with the theory of symptom management,then revise the intervention program by Delphi expert consultation method,and evaluate the safety,feasibility and effectiveness of the intervention program through the pilot studies,and form the final complete version of PSF comprehensive intervention program in acute stage.Part 2:Clinical empirical study of intervention program was constructed for post-stroke fatigue during acute phase based on symptom management theory.Selected 120 cases of PSF(FSS≥36)who met the inclusion criteria during acute phase in neurology department of a third class a hospital in Zhuhai.The 120 cases were divided into two groups by random number generator of SPSS22.0 software:the treatment group(60 cases)and the control group(60 cases).The control group adopts conventional treatment and nursing care,and the treatment group adopts a comprehensive intervention program based on symptom management theory on the basis of the control group.Collect the general data and clinical characteristics related data of the research subjects within 24 hours of admission,fatigue severity scale(FSS),stroke self-efficacy scale(SSEQ)and stroke specific quality of life scale(SS-QOL)were used to assess the fatigue severity,self-efficacy and quality of daily life of patients before intervention,2 weeks and 4weeks after intervention.Results:Part 1:After the literature search process,23 articles were included,and 18articles were included in the risk assessment of bias,and the results of methodological quality assessment were all Grade B.On the basis of literature review and symptom management theory,the first draft of comprehensive intervention plan for PSF in acute stage was constructed:(1)Objects of intervention:patients diagnosed with PSF in acute stage.(2)Implementers:trained and qualified nurses;(3)Intervention time:4weeks,1time/d,20-30min/time;(4)Intervention place:Neurology ward;(5)Intervention content:symptom assessment,cognitive intervention,psychological intervention,behavior therapy,sleep management,diet guidance.The first draft of intervention plan was designed as Delphi expert consultation questionnaire.20 experts from Guangdong,Chongqing,Anhui and Liaoning were selected to participate in Delphi expert consultation in the fields of Neurology,Rehabilitation medicine,Psychology,Nutrition and Clinical nursing,etc.The effective response rate of two rounds of consultation was 100%.The expert familiarity(CS)was 0.80,the expert judgment basis(CA)was 0.93,and the expert group authority coefficient(CR)was 0.87.The coordination coefficients of the first level indicators of the two rounds of expert consultation were 0.18(x~2=17.64,P=0.003)and 0.21(x~2=21.12,P=0.05),respectively;The coordination coefficients of secondary indicators were 0.10(x~2=61.78,P=0.001)and 0.11(x~2=72.15,P<0.001),respectively.The mean of importance assignment in two rounds was greater than 4.0,and the coefficient of variation was less than 0.25.Finally,a revised draft of the acute-phase PSF comprehensive intervention plan with6 first-level indicators and 52 second-level indicators was formed.A Pilot study was conducted on 10 study subjects that met the inclusion criteria,and the result feedback verified that the intervention content was feasible,effective,and safe and reliable to operate;and the final draft of the acute-phase PSF comprehensive intervention plan was formed.Part 2:(1)A total of 109 study subjects completed the 4-week intervention measures;55 cases in the treatment group and 54 cases in the control group.Before the intervention,There was no statistically significant difference in the baseline information,FSS score,SSEQ score,SS-QOL total score,and each dimension of SS-QOL scale scores between the two groups before intervention(P>0.05).(2)After 2 weeks and 4 weeks of intervention,the results of intention-to-treat(ITT)and per protocol(PP)showed that the FSS scores of the treatment group were significantly lower than those of the control group(P<0.05);SSEQ scores,SS-QOL total scores were significantly higher than those of the control group(P<0.05).After 2 weeks of intervention,the ITT results showed that the two groups had no difference in SS-QOL scale dimensional thinking,upper limb function,and visual acuity scores(P>0.05),and the differences in the scores of other dimensions were statistically significant(P<0.05);the PP results It shows that there is no difference in dimensional thinking score only(P>0.05).(3)Two methods of ITT and PP using repeated measures ANOVA and generalized estimation equation analysis results show FSS score,SSEQ score,SS-QOL total score within the time effect(baseline,intervention 2 weeks,intervention 4 weeks),interaction effect(group×time),between groups(treatment group and control group),the difference is statistical significance(P<0.05).There was no statistically significant difference in the interaction of SS-QOL dimensional thinking,upper limb function,and visual acuity(P>0.05),and there was an interaction in the scores of the other dimensions(P<0.05);the differences in the intra-group effects of all dimensions were statistically significant(P>0.05);The results of ITT showed that the differences in the effects of the dimensions of energy,family role,language,activity ability,and work/labor were statistically significant(P<0.05),while the differences in the effects of the other dimensions were not statistically significant(P>0.05);The PP results showed that the effect of different interventions on energy,family role,language,activity ability,personality,vision,work/labor scores was statistically significant(P<0.05),and the differences in scores of other dimensions were not statistically significant(P>0.05).(4)The treatment group was compared in pairs at different time points;the results of ITT and PP showed that the FSS score,SSEQ score,and SS-QOL total score all changed significantly over time(P<0.05).Except for dimensional thinking and visual acuity scores,there was no difference between the intervention for 2 weeks and the intervention for 4 weeks(P>0.05),and the other dimensions changed over time(P<0.05).Conclusion:(1)A qualitative analysis of non-pharmaceutical interventions for PSF through systematic evaluation can provide evidence-based basis for constructing intervention programs to improve the fatigue level of patients with acute stroke.(2)A comprehensive intervention program based on symptom management theory can improve the fatigue level of patients,and improve the self-efficacy and quality of daily life of patients during acute stage. |