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Acceptability of the method of administration of a patient-reported outcome measure (PROM) with stroke survivors, a randomised controlled trial protocol.

ABSTRACT: BACKGROUND:UK-wide national clinical guidelines promote routine 6-month post-stroke follow-up assessment. However, as part of this 6-month assessment little information is gathered from the patient's perspective. The means of collecting this patient-centred information might be served best by a patient-reported outcome measure (PROM) at the 6-month assessment time point. Currently, four different methods of 6-month follow-up assessment occur; the most common being face-to-face interview followed by telephone interview, postal questionnaire and online questionnaire. Therefore, this study will investigate if the acceptability of telephone, online or postal administration of a PROM at the 6-month post-stoke time point is not inferior to face-to-face administration. METHODS/DESIGN:A UK multicentre, blinded (analyst and researcher), pragmatic, non-inferiority study, with 80% power using a 2.5% non-inferiority margin was designed to compare the acceptability of three modes of administration (telephone interview, postal questionnaire and online questionnaire) compared with face-to-face interview administration of a PROM. We plan to approach and randomise a minimum of 808 potentially eligible participants, 202 participants per group. DISCUSSION:The aim of this ongoing research is to understand if there is a difference between face-to-face administration and the other three methods of administering a PROM as a patient-centred supplement to the 6-month review for stroke survivors. In utilising a pragmatic design, it is believed that this study will offer UK wide generalisable results, of the acceptability of the methods under investigation, to inform clinicians and commissioners of stroke services. TRIALS REGISTRATION:ClinicalTrials.gov: NCT03177161 . Registered on 6 June 2017.

SUBMITTER: Smith A

PROVIDER: S-EPMC6030753 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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Acceptability of the method of administration of a patient-reported outcome measure (PROM) with stroke survivors, a randomised controlled trial protocol.

Smith Alexander A Pennington Anna A Carter Ben B Gething Stephanie S Price Michelle M White James J Dewar Richard R Hewitt Jonathan J

Trials 20180703 1

<h4>Background</h4>UK-wide national clinical guidelines promote routine 6-month post-stroke follow-up assessment. However, as part of this 6-month assessment little information is gathered from the patient's perspective. The means of collecting this patient-centred information might be served best by a patient-reported outcome measure (PROM) at the 6-month assessment time point. Currently, four different methods of 6-month follow-up assessment occur; the most common being face-to-face interview ...[more]

PMID: 29970156

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Project description:BackgroundDue to a lack of an appropriate disease-specific patient-reported outcome (PRO) instrument for chronic heart failure including its social support and treatment aspects in China, this study was performed to develop a patient-reported outcome measure (PROM) for patients with chronic heart failure and evaluate its reliability, validity, and feasibility.MethodsAccording to the standard PROM guidelines established by the Food and Drug Administration, an item pool was formed by reviewing a large amount of relevant literature and interviewing patients with chronic heart failure about their main symptoms. Thus, the primary scale was created after adjusting the items and language with the help of patients and experts in the field. Next, 155 patients from 8 hospitals in different districts were recruited for a pilot survey using questionnaires containing these items. The patients' responses were analyzed using the classical test theory and item response theory to select high-quality items and determine the subdomains of the scale. This was followed by a formal investigation in the same eight hospitals. In total, 360 patients and 100 healthy subjects were included to evaluate the reliability, validity, and feasibility of the items. Through this process, the final scale was established.ResultsThe final scale comprised 12 subdomains with 57 items related to physical, psychological, social, and therapeutic areas. The data analysis results of the formal investigation showed that the PROM for chronic heart failure had good reliability, validity, and feasibility. Reliability was verified by Cronbach's alpha coefficient, which was 0.913 for the total scale, 0.903 for the physical domain, 0.941 for the psychological domain, 0.827 for the social domain, and 0.839 for the therapeutic domain. The construct validity results met the relative criteria of confirmatory factor analysis. Discriminant validity was represented by score comparisons of nine subdomains. The response rate and the effective rate of return of the CHF-PROM were 98.94% and 98.92%, respectively.ConclusionsThe final scale coincides with the theoretical framework and better reflects the overall quality of life of patients with chronic heart failure. This scale can be used as a valid instrument to evaluate clinical treatment and clinical trials of chronic heart failure.

Project description:BackgroundThe majority of stroke survivors experience long-term impairments. Regular physical activity and other lifestyle modifications play an important role in rehabilitation. Outpatient rehabilitation using telemedicine might be suitable to improve functional ability and long-term secondary prevention. The Strokecoach Intervention Program (SIP, Strokecoach GmbH, Cologne, Germany) comprises training, coaching and monitoring with the aim of improving or at least maintaining functional independence and preventing further stroke through more targeted physical activity. The SIP is provided as blended care, which refers to the integrated and coordinated delivery of healthcare services that combines traditional in-person interactions with technology-mediated interventions, optimizing the use of both face-to-face and virtual modalities to enhance patient outcomes.ObjectiveThe aim of this study was to evaluate the acceptance of the SIP by the participants and its practical application, as well as to obtain initial indications of effects of the SIP on the basis of patient-related outcome measures, blood pressure measurements and recording of physical activity in parallel with the intervention.MethodsData from individuals with stroke participating in the SIP were analyzed retrospectively. Within the SIP, participants received an application-based training program, were instructed to measure their blood pressure daily and to wear an activity tracker (pedometer). During the intervention period of either 6 or 12 weeks, the participants were supported and motivated by a personal coach via a messenger application. The primary outcomes of the analysis were recruitment, acceptance of and satisfaction with the SIP. Secondary outcomes included functional measures, mobility and health-related quality of life.ResultsA total of 122 individuals with stroke could be recruited for the SIP. A total of 96 out of 122 were able to start the program (54% female, mean age 54.8 (SD = 13.1), 6.1 (SD = 6.6) years after stroke onset) and 88 completed the SIP. Participants wore the activity tracker on 66% and tracked their blood pressure on 72% of their intervention days. A further analyzed subgroup of 38 participants showed small improvements in patient-reported outcomes such as health-related quality of life (SF-36) with an increase of 12 points in the subdomain mental health, vitality (12.6) and physical functioning (9.1). However, no statistically significant improvements were found in other performance-based measures (Timed Up and Go test, gait speed).ConclusionsThis study showed that a blended therapy approach for stroke survivors with mild to moderate impairments in the chronic phase is feasible and was highly accepted by participants, who benefitted from the additional coaching.

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Acceptability of the method of administration of a patient-reported outcome measure (PROM) with stroke survivors, a randomised controlled trial protocol.

Publications

Acceptability of the method of administration of a patient-reported outcome measure (PROM) with stroke survivors, a randomised controlled trial protocol.

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