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A mixed-methods feasibility study of an arts-based intervention for patients receiving maintenance haemodialysis.

ABSTRACT: BACKGROUND:Haemodialysis can negatively impact quality of life and mental health. Arts-based interventions used successfully in other settings to improve health and well-being, could help address the impact of haemodialysis. This study aimed to evaluate the feasibility and acceptability of conducting a randomised controlled trial (RCT) of an arts-based intervention for patients receiving haemodialysis. METHODS:A parallel convergent mixed-methods design was used, including a pilot cluster RCT and qualitative process evaluation. Phase 1 evaluated recruitment and retention rates through a pilot cluster RCT at a single haemodialysis unit in Northern Ireland. Participants included patients who received haemodialysis for ESKD, were over the age of 18 and had the capacity to consent. These participants were randomised to the intervention or control group according to their haemodialysis shift. The intervention involved six one-hour, one-to-one facilitated arts sessions during haemodialysis. Phase 2 explored intervention and trial acceptability through a qualitative process evaluation using semi-structured interviews based on the RE-AIM framework. Participants included 13 patients who participated in phase 1 of the study, including 9 participants from the experimental group and four participants from the control group, and nine healthcare professionals who were present on the unit during implementation. RESULTS:Out of 122 outpatient haemodialysis patients, 94 were assessed as eligible for participation. Twenty-four participants were randomised, meaning 80% of the target sample size was recruited and the attrition rate at 3?months was 12.5% (n?=?3). Participants viewed the arts as more accessible and enjoyable than anticipated following implementation. All participants who started the intervention (n?=?11) completed the full six sessions. Qualitative benefits of the intervention suggest improvements in mental well-being. Patient choice and facilitation were important factors for successful implementation. CONCLUSION:An arts-based intervention for patients receiving haemodialysis is acceptable for both patients and healthcare professionals, and a definitive trial is feasible. The intervention may help improve mental-wellbeing in patients receiving haemodialysis, but this requires further investigation in a definitive trial. TRIAL REGISTRATION:The trial was prospectively registered on clinicaltrials.gov on 14/8/2018, registration number NCT03629496 .

SUBMITTER: Carswell C

PROVIDER: S-EPMC7678271 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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A mixed-methods feasibility study of an arts-based intervention for patients receiving maintenance haemodialysis.

Carswell Claire C Reid Joanne J Walsh Ian I Johnston William W McAneney Helen H Mullan Robert R Lee Jenny B JB Nelson Hugh H Matthews Michael M Weatherup Elizabeth E Spencer Andrea A Michelo Jean J Quail Anne A Kielty Grainne G Mackenzie Alistair A Elliott Jenny J Arbuckle Nicola N Wilson Anna A Noble Helen H

BMC nephrology 20201119 1

<h4>Background</h4>Haemodialysis can negatively impact quality of life and mental health. Arts-based interventions used successfully in other settings to improve health and well-being, could help address the impact of haemodialysis. This study aimed to evaluate the feasibility and acceptability of conducting a randomised controlled trial (RCT) of an arts-based intervention for patients receiving haemodialysis.<h4>Methods</h4>A parallel convergent mixed-methods design was used, including a pilot ...[more]

PMID: 33213413

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Project description:BackgroundEnd-stage kidney disease is a life-changing illness. Many patients require haemodialysis, a treatment that impacts profoundly on quality of life and mental health. Arts-based interventions have been used in other healthcare settings to improve mental health and quality of life; therefore, they may help address the impact of haemodialysis by improving these outcomes. However, there is a lack of evidence assessing their effectiveness in this population and few randomised controlled trials (RCTs) evaluating the effectiveness of complex arts-based interventions.MethodsThe aims of this study are to establish the feasibility of a cluster RCT of an arts-based intervention for patients with end-stage kidney disease whilst receiving haemodialysis through a cluster randomised pilot study, explore the acceptability of the intervention with a process evaluation and explore the feasibility of an economic evaluation. The study will have three phases. The first phase consists of a cluster randomised pilot study to establish recruitment, participation and retention rates. This will involve the recruitment of 30 participants who will be randomly allocated through cluster randomisation according to shift pattern to experimental and control group. The second phase will be a qualitative process evaluation to establish the acceptability of the intervention within a clinical setting. This will involve semi-structured interviews with 13 patients and three focus groups with healthcare professionals. The third phase will be a feasibility economic evaluation to establish the best methods for data collection within a future cluster RCT.DiscussionArts-based interventions have been shown to improve quality of life in healthcare settings, but there is a lack of evidence evaluating arts-based interventions for patients receiving haemodialysis. This study aims to assess the feasibility of a future cluster RCT assessing the impact of an arts-based intervention on the wellbeing and mental health of patients receiving haemodialysis and identify the key factors leading to successful implementation. The hope is this study will inform a trial that can influence future healthcare policy by providing robust evidence for arts-based interventions within the haemodialysis setting.Trial registrationThe trial was prospectively registered on clinicaltrials.gov on 14/8/2018, registration number NCT03629496.

Project description:ObjectivesFrailty is highly prevalent in haemodialysis (HD) patients, leading to poor outcomes. This study aimed to determine whether a randomised controlled trial (RCT) of intradialytic exercise is feasible for frail HD patients, and explore how the intervention may be tailored to their needs.DesignMixed-methods feasibility.Setting and participantsPrevalent adult HD patients of the CYCLE-HD trial with a Clinical Frailty Scale Score of 4-7 (vulnerable to severely frail) were eligible for the feasibility study.InterventionsParticipants in the exercise group undertook 6 months of three times per week, progressive, moderate intensity intradialytic cycling (IDC).OutcomesPrimary outcomes were related to feasibility. Secondary outcomes were falls incidence measured from baseline to 1 year following intervention completion, and exercise capacity, physical function, physical activity and patient-reported outcomes measured at baseline and 6 months. Acceptability of trial procedures and the intervention were explored via diaries and interviews with n=25 frail HD patients who both participated in (n=13, 52%), and declined (n=12, 48%), the trial.Results124 (30%) patients were eligible, and of these 64 (52%) consented with 51 (80%) subsequently completing a baseline assessment. n=24 (71% male; 59±13 years) dialysed during shifts randomly assigned to exercise and n=27 (81% male; 65±11 years) shifts assigned to usual care. n=6 (12%) were lost to follow-up. The exercise group completed 74% of sessions. 27%-89% of secondary outcome data were missing. Frail HD patients outlined several ways to enhance trial procedures. Maintaining ability to undertake activities of daily living and social participation were outcomes of primary importance. Participants desired a varied exercise programme.ConclusionsA definitive RCT is feasible, however a comprehensive exercise programme may be more efficacious than IDC in this population.Trial registration numbersISRCTN11299707; ISRCTN12840463.

Project description:BackgroundTreatment and prevention guidelines highlight the key role of health information and evidence-based psychosocial interventions for adolescent depression. Digital health technologies and psychoeducational interventions have been recommended to help engage young people and to provide accurate health information, enhance self-management skills, and promote social support. However, few digital psychoeducational interventions for adolescent depression have been robustly developed and evaluated in line with research guidance.ObjectiveWe aimed to evaluate the feasibility, acceptability, and potential impact of a theory-informed, co-designed digital intervention program, MoodHwb.MethodsWe used a mixed methods (quantitative and qualitative) approach to evaluate the program and the assessment process. Adolescents with or at elevated risk of depression and their parents and carers were recruited from mental health services, school counselors and nurses, and participants from a previous study. They completed a range of questionnaires before and after the program (related to the feasibility and acceptability of the program and evaluation process, and changes in mood, knowledge, attitudes, and behavior), and their Web usage was monitored. A subsample was also interviewed. A focus group was conducted with professionals from health, education, social, and youth services and charities. Interview and focus group transcripts were analyzed using thematic analysis with NVivo 10 (QSR International Pty Ltd).ResultsA total of 44 young people and 31 parents or carers were recruited, of which 36 (82%) young people and 21 (68%) parents or carers completed follow-up questionnaires. In all, 19 young people and 12 parents or carers were interviewed. Overall, 13 professionals from a range of disciplines participated in the focus group. The key themes from the interviews and groups related to the design features, sections and content, and integration and context of the program in the young person's life. Overall, the participants found the intervention engaging, clear, user-friendly, and comprehensive, and stated that it could be integrated into existing services. Young people found the "Self help" section and "Mood monitor" particularly helpful. The findings provided initial support for the intervention program theory, for example, depression literacy improved after using the intervention (difference in mean literacy score: 1.7, 95% CI 0.8 to 2.6; P<.001 for young people; 1.3, 95% CI 0.4 to 2.2; P=.006 for parents and carers).ConclusionsFindings from this early stage evaluation suggest that MoodHwb and the assessment process were feasible and acceptable, and that the intervention has the potential to be helpful for young people, families and carers as an early intervention program in health, education, social, and youth services and charities. A randomized controlled trial is needed to further evaluate the digital program.

Project description:BackgroundPatients with postmenopausal nonmetastatic estrogen receptor-positive breast cancer often experience a reduced quality of life after primary treatment. The disease and treatment trajectory consists of surgery followed by chemotherapy or radiation therapy. Upon this, maintenance hormone therapy with an aromatase inhibitor can result in several physical and psychosocial symptoms. Optimal symptom control during maintenance therapy is central to maintaining the patient's quality of life.ObjectiveThis study aims to (1) develop an electronic symptom management tool for patients with postmenopausal early breast cancer receiving maintenance aromatase inhibitors with an endocrine aspect and (2) assess the feasibility, acceptability, and usability of the pilot version of the Bone@BC app. Furthermore, longitudinally, symptom prevalence and quality of life for patients with postmenopausal nonmetastatic estrogen receptor-positive breast cancer will be explored.MethodsThis study follows a multistage research plan. In stage 1, a systematic literature review to establish an overview of aromatase inhibitor-related symptoms reported by postmenopausal women with nonmetastatic estrogen receptor-positive breast cancer will be completed. In stage 2, a comprehensive overview of symptoms related to aromatase inhibitors (letrozole, exemestane, and anastrozole) will be performed (eg, by reviewing medical leaflets and guidelines). In stage 3, an electronic app with a user-friendly Patient Concern Inventory list to comprise symptoms and concerns will be developed. Last, in stage 4, a convergent mixed methods feasibility study of the pilot version of the Bone@BC app will be conducted. A total of 45 patients with postmenopausal nonmetastatic estrogen receptor-positive breast cancer will use the app daily for symptom identification and respond to 6 serial patient-reported outcome measurements for 12 weeks. Finally, semistructured interviews will be performed. The primary outcome includes consent rate, attrition rate, retention rates, technical issues, and adherence, assessed using preestablished criteria on feasibility and a mixed methods approach for exploring acceptability. A patient advisory board consisting of 5 women with breast cancer is recruited to include their perspectives and experiences in the planning, organization, implementation, and dissemination of the research throughout the project.ResultsAt the time of submitting this paper (January 2024), a total of 23 patients have been included in the stage 2 medical audit over the recruitment period of 3 months (November 2022 to February 2023), and 19 patients have been enrolled in stage 2, the semistructured patient interviews.ConclusionsThis protocol describes a study investigating the feasibility, acceptability, and usability of the symptom management tool Bone@BC developed for patients with breast cancer with an endocrine aspect.Trial registrationClinicalTrails.gov NCT05367830; https://clinicaltrials.gov/ct2/show/NCT05367830.International registered report identifier (irrid)DERR1-10.2196/49549.

Project description:BackgroundDigital mental health interventions may help middle-aged and older adults with depression overcome barriers to accessing traditional care, but few studies have investigated their use in this population.ObjectiveThis pilot study examines the feasibility, acceptability, and potential efficacy of the Meru Health Program, an 8-week mobile app-delivered intervention.MethodsA total of 20 community-dwelling middle-aged and older adults (age: mean 61.7 years, SD 11.3) with elevated depressive symptoms participated in a single-arm pilot study investigating the Meru Health Program, an app-delivered intervention supported by remote therapists. The program primarily uses mindfulness and cognitive behavioral skills to target depressive symptoms. A semistructured interview was completed at the baseline to establish current psychiatric diagnoses. Depressive symptoms were measured using the Patient Health Questionnaire and Patient-Reported Outcomes Measurement Information System (PROMIS) depression measures. Anxiety symptoms were measured using the Generalized Anxiety Disorder Scale and the PROMIS Anxiety measure. User experience and acceptability were examined through surveys and qualitative interviews.ResultsIn total, 90% (18/20) of the participants completed the program, with 75% (15/20) completing at least 7 of the 8 introductory weekly lessons. On average, participants completed 60 minutes of practice and exchanged 5 messages with their therapists every week. The app was rated as helpful by 89% (17/19) participants. Significant decreases in depressive (P=.03) and anxiety symptom measures (P=.01) were found; 45% (9/20) of participants showed clinically significant improvement in either depressive symptoms or anxiety symptoms.ConclusionsThe findings suggest that the commercially available Meru Health Program may be feasible, acceptable, and potentially beneficial to middle-aged and older adults. Although larger controlled trials are needed to demonstrate efficacy, these findings suggest that digital health interventions may benefit adults of all ages.

Project description:BackgroundPsychological research examining the nature and workings of gratitude has burgeoned over the past two decades. However, few studies have considered gratitude in the palliative care context. Based on an exploratory study which found that gratitude was correlated with better quality of life and less psychological distress in palliative patients, we designed and piloted a gratitude intervention where palliative patients and a carer of their choice wrote and shared a gratitude letter with each other. The aims of this study are to establish the feasibility and acceptability of our gratitude intervention and provide a preliminary assessment of its effects.MethodsThis pilot intervention study adopted a mixed-methods, concurrent nested, pre-post evaluation design. To assess the intervention's effects, we employed quantitative questionnaires on quality of life, quality of relationship, psychological distress, and subjective burden, as well as semi-structured interviews. To assess feasibility, we considered patients and carers' eligibility, participation and attrition rates, reasons for refusal to participate, appropriateness of intervention timeframe, modalities of participation, and barriers and facilitators. Acceptability was assessed through post-intervention satisfaction questionnaires.ResultsThirty-nine participants completed the intervention and twenty-nine participated in interviews. We did not find any statistically significant pre/post intervention changes for patients, but found significant decrease in psychological distress for carers in terms of depression (median = 3 at T0, 1.5 at T1, p = .034) and total score (median = 13 at T0, 7.5 at T1, p = .041). Thematic analysis of interviews indicates that overall, the intervention had: (1) multiple positive outcomes for over a third of interviewees, in the form of positive emotional, cognitive, and relational effects; (2) single positive outcomes for nearly half of interviewees, who experienced emotional or cognitive effects; (3) no effect on two patients; and (4) negative emotional effects on two patients. Feasibility and acceptability indicators suggest that the intervention was well received by participants, and that it should adopt flexible modalities (e.g. writing or dictating a gratitude message) to ensure that it is feasible and adapted to individual needs and preferences.ConclusionsLarger scale deployment and evaluation of the gratitude intervention, including a control group, is warranted in order to have a more reliable evaluation of its effectiveness in palliative care.

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A mixed-methods feasibility study of an arts-based intervention for patients receiving maintenance haemodialysis.

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A mixed-methods feasibility study of an arts-based intervention for patients receiving maintenance haemodialysis.

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