Dataset Information

HELPing older people with very severe chronic obstructive pulmonary disease (HELP-COPD): mixed-method feasibility pilot randomised controlled trial of a novel intervention.

ABSTRACT: Extending palliative care to those with advanced non-malignant disease is advocated, but the implications in specific conditions are poorly understood.We piloted a novel nurse-led intervention, HELPing older people with very severe chronic obstructive pulmonary disease (HELP-COPD), undertaken 4 weeks after discharge from hospital, which sought to identify and address the holistic care needs of people with severe COPD.This 6-month mixed-method feasibility pilot trial randomised (ratio 3:1) patients to HELP-COPD or usual care. We assessed the feasibility of using validated questionnaires as outcome measures and analysed the needs/actions recorded in the HELP-COPD records. Semi-structured interviews with a purposive sample of patients, carers and professionals explored the perceptions of HELP-COPD. Verbatim transcriptions and field notes were analysed using Normalisation Process Theory as a framework.We randomised 32 patients (24 to HELP-COPD); 19 completed the study (death=3, ill-health=4, declined=6). The HELP-COPD record noted a mean of 1.6 actions/assessment, mostly provision of information or self-help actions: only five referrals were made. Most patients were positive about HELP-COPD, discussing their concerns and coping strategies in all domains, but the questionnaires were burdensome for some patients. Adaptation to their slowly progressive disability and a strong preference to rely on family support was reflected in limited acceptance of formal services. Professionals perceived HELP-COPD as addressing an important aspect of care, although timing overlapped with discharge planning.The HELP-COPD intervention was well received by patients and the concept resonated with professionals, although delivery post discharge overlapped with existing services. Integration of brief holistic care assessments in the routine primary care management of COPD may be more appropriate.

SUBMITTER: Buckingham S

PROVIDER: S-EPMC4532154 | biostudies-literature | 2015 Apr

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

HELPing older people with very severe chronic obstructive pulmonary disease (HELP-COPD): mixed-method feasibility pilot randomised controlled trial of a novel intervention.

Buckingham Susan S Kendall Marilyn M Ferguson Susie S MacNee William W Sheikh Aziz A White Patrick P Worth Allison A Boyd Kirsty K Murray Scott A SA Pinnock Hilary H

NPJ primary care respiratory medicine 20150416

<h4>Background</h4>Extending palliative care to those with advanced non-malignant disease is advocated, but the implications in specific conditions are poorly understood.<h4>Aims</h4>We piloted a novel nurse-led intervention, HELPing older people with very severe chronic obstructive pulmonary disease (HELP-COPD), undertaken 4 weeks after discharge from hospital, which sought to identify and address the holistic care needs of people with severe COPD.<h4>Methods</h4>This 6-month mixed-method feasi ...[more]

PMID: 26028347

Similar Datasets

Project description:BackgroundJob loss, austerity measures, financial difficulties and house repossession contribute to the risk of self-harm and suicide during recessions. Navigating the benefits system and accessing sources of welfare and debt advice is a difficult experience for vulnerable people, further contributing to their distress. Whilst there is some evidence that advice-type interventions can lead to financial gain, there is mixed evidence for their effectiveness in improving mental health in those experiencing financial difficulties. There have been no interventions targeting those who have self-harmed due to economic hardship.MethodsOur aim was to determine the feasibility and acceptability of a brief psychosocial intervention (the 'HOPE' service) for people presenting to hospital emergency departments (ED) following self-harm or in acute distress because of financial, employment or welfare (benefit) difficulties. Nineteen people consented to random allocation to the intervention or control arm on a 2:1 basis. Participants randomised to the intervention arm (n =?13) received up to six sessions of 1:1 support provided by community support staff trained in Motivational Interviewing (MI). Control participants (n =?6) received a one-off session signposting them to relevant support organisations. Fourteen participants were followed up after 3 months. Participants and mental health workers took part in qualitative interviews. The acceptability of outcome measures including the PHQ-9, GAD-7, repeat self-harm, EQ5D-5 L and questions about debt, employment and welfare benefits were explored.ResultsInterviews indicated the main benefits of the service as the resolution of specific financial problems and receiving support when participants were feeling most vulnerable. Randomisation was acceptable to most participants although not always fully understood and control participants could be disappointed. Recruitment was slow (1-2 per month). The outcome measures were acceptable and appeared sensitive to change.DiscussionThe HOPE intervention is feasible and acceptable. There was evidence of need and it is a relatively inexpensive intervention. Refining aspects of the intervention would be straightforward. A full-scale RCT would be feasible, if broadened eligibility criteria led to increased recruitment and improvements were made to staff training and support.Trial registrationISRCTN58531248.

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:BackgroundAccumulating evidence supports the role of a Mediterranean diet (MD) in cognition, with a greater adherence to a MD associated with reduced dementia risk. It is important to understand how best to achieve behaviour change towards a MD, particularly in non-Mediterranean and high-risk populations. The aim of this study was to evaluate the feasibility of a MD and lifestyle education intervention (THINK-MED) among older adults with cognitive impairment.MethodsQualitative interviews (Phase I), conducted with mild cognitive impairment (MCI) participants, evaluated the intervention materials to allow refinement before pilot testing. THINK-MED was a 12-month, pilot RCT (Phase II) whereby MCI participants were randomised into one of three groups: education on one occasion vs education staged and supported by a dietitian vs control. The primary outcome was a change in MD score. Secondary outcome measurements were collected to gather data on variability of the outcomes to inform a full trial power calculation and to test their acceptability. Slower recruitment rates necessitated a change in primary outcome to a revised focus primarily on feasibility. A sub-study of the same THINK-MED intervention and data collection measures was also conducted among community-dwelling participants with subjective cognitive impairment (SCI) (NCT03569319).ResultsA total of 20 participants (n = 15 MCI; n = 5 SCI) were enrolled in the THINK-MED study. However, there were 10 (50%) participants (n = 9 MCI; n = 1 SCI) who withdrew from the study. Although, those who remained in the intervention rated and evaluated their experience as generally positive, recruitment and retention, especially from a MCI population, was extremely challenging. This highlights the complex needs of this heterogeneous clinical cohort. Recruiting participants from a community-based sample with SCI was more feasible, reaching a wider audience in a shorter time period. There were challenges relating to data collection and incompleteness, with the occurrence of missing data particularly among the questionnaire-based assessments.ConclusionsOwing to the challenges with recruitment and retention of older adults with cognitive impairment in this study, it is difficult to confirm if this intervention is feasible. This research has highlighted considerations for a future trial, including a review of the recruitment strategies used and prioritisation of the outcome measures assessed.Trial registrationClinical trials registration NCT03265522 / NCT03569319.

Project description:ObjectivesPilot feasibility randomised controlled trial (RCT) for the singing groups for people with aphasia (SPA) intervention to assess: (1) the acceptability and feasibility of participant recruitment, randomisation and allocation concealment; (2) retention rates; (3) variance of continuous outcome measures; (4) outcome measure completion and participant burden; (5) fidelity of intervention delivery; (6) SPA intervention costs; (7) acceptability and feasibility of trial and intervention to participants and others involved.DesignA two-group, assessor-blinded, randomised controlled external pilot trial with parallel mixed methods process evaluation and economic evaluation.SettingThree community-based cohorts in the South-West of England.ParticipantsEligible participants with post-stroke aphasia were randomised 1:1 to SPA or control.InterventionThe manualised SPA intervention was delivered over 10 weekly singing group sessions, led by a music facilitator and assisted by an individual with post-stroke aphasia. The intervention was developed using the Information-Motivation-Behavioural skills model of behaviour change and targeted psychosocial outcomes. Control and intervention participants all received an aphasia information resource pack.Outcome measuresCollected at baseline, 3 and 6 months post-randomisation, candidate primary outcomes were measured (well-being, quality of life and social participation) as well as additional clinical outcomes. Feasibility, acceptability and process outcomes included recruitment and retention rates, and measurement burden; and trial experiences were explored in qualitative interviews.ResultsOf 87 individuals screened, 42 participants were recruited and 41 randomised (SPA=20, control=21); 36 participants (SPA=17, control=19) completed 3-month follow-up, 34 (SPA=18, control=16) completed 6-month follow-up. Recruitment and retention (83%) were acceptable for a definitive RCT, and participants did not find the study requirements burdensome. High fidelity of the intervention delivery was shown by high attendance rates and facilitator adherence to the manual, and participants found SPA acceptable. Sample size estimates for a definitive RCT and primary/secondary outcomes were identified.ConclusionsThe SPA pilot RCT fulfilled its objectives, and demonstrated that a definitive RCT of the intervention would be both feasible and acceptable.Trial registration numberNCT03076736.

Project description:OBJECTIVES:To pilot a peer-based intervention for people living with HIV who used substances, had challenges with antiretroviral adherence and would be discharged from hospital to community. STUDY DESIGN:A community-based, quasi-experimental pilot intervention study designed to assess feasibility, acceptability and connection to a community-based HIV organisation. SETTING:This study was conducted in Toronto, Canada, at Casey House (CH; hospital for people living with HIV) in collaboration with the AIDS Committee of Toronto (ACT; community-based HIV organisation). PARTICIPANTS:People living with HIV who were CH inpatient between 1 April 2017 and 31 March 2018, struggled with antiretroviral adherence, actively used substances and would be discharged to community were eligible. Forty people met criteria, 19 were approached by an inpatient nurse and 17 consented. Average age was 48.8 years (SD=11.4), 58.8% were male and participants averaged 7.8 physical and mental health comorbidities (SD=3.1). INTERVENTION:Titled 'The ART of Conversation', the three-pronged personalised intervention was developed through input from CH clients and ACT volunteers, all living with HIV. Intervention components were (a) predischarge goal-setting (adherence, substance use and self-identified goal) with the study nurse; (b) predischarge meeting with an HIV+ peer volunteer (PV) and (c) nine postdischarge phone calls between PV and participant, once per day for 3 days, then once per week for 6 weeks. PRIMARY OUTCOMES:Feasibility was measured through proportion of eligible participants recruited and PV availability. Acceptability was assessed through participant interviews at three times (preintervention, post-intervention and 6 weeks follow-up) and through PV call logs. Client records determined connection to ACT within the study timeframe. RESULTS:Twelve participants completed the intervention and nine connected with ACT. Predischarge goal-setting and PV meeting were both feasible and acceptable. Postdischarge phone calls were a challenge as half of completers missed at least one call. CONCLUSIONS:Although predischarge goal-setting and PV meeting were feasible, methods to maintain connection following discharge require further investigation.

Project description:BackgroundFrailty is associated with adverse health outcomes in people with chronic kidney disease (CKD). Evidence supporting targeted interventions is needed. This pilot randomised controlled trial (RCT) aimed to inform the design of a definitive RCT evaluating the effectiveness of a home-based exercise intervention for pre-frail and frail older adults with CKD.MethodsParticipants were recruited from nephrology outpatient clinics to this two-arm parallel group mixed-methods pilot RCT. Inclusion criteria were: ≥65 years old; CKD G3b-5; and Clinical Frailty Scale score ≥4. Participants categorised as pre-frail or frail using the Frailty Phenotype were randomised to a 12-week progressive multi-component home-based exercise programme or usual care. Primary outcome measures included eligibility, recruitment, adherence, outcome measure completion and participant attrition rate. Semi-structured interviews were conducted with participants to explore trial and intervention acceptability.ResultsSix hundred and sixty-five patients had an eligibility assessment with 217 (33%; 95% CI 29, 36) eligible. Thirty-five (16%; 95% CI 12, 22) participants were recruited. Six were categorised as robust and withdrawn prior to randomisation. Fifteen participants were randomised to exercise and 14 to usual care. Eleven (73%; 95% CI 45, 91) participants completed ≥2 exercise sessions/week. Retained participants completed all outcome measures (n = 21; 100%; 95% CI 81, 100). Eight (28%; 95% CI 13, 47) participants were withdrawn. Fifteen participated in interviews. Decision to participate/withdraw was influenced by perceived risk of exercise worsening symptoms. Participant perceived benefits included improved fitness, balance, strength, well-being, energy levels and confidence.ConclusionsThis pilot RCT demonstrates that progression to definitive RCT is possible provided recruitment and retention challenges are addressed. It has also provided preliminary evidence that home-based exercise may be beneficial for people living with frailty and CKD.Trial registrationISRCTN87708989; https://clinicaltrials.gov/.

Project description:BackgroundComprehensive Geriatric Assessment (CGA)is a widely accepted intervention for frailty and can be cost-effective within a primary care setting.ObjectiveTo explore the feasibility of identifying older adults with frailty and assess the subsequent implementation of a tailored CGA with care and support plan by Advanced Nursing Practitioners (ANPs).MethodsA mixed-method parallel randomised controlled trial was conducted. Participants were recruited from two General Practice (GP) centres between January and June 2019. Older adults with confirmed frailty, as assessed by practice nurses, were randomised, using a web service, to the intervention or treatment-as-usual (TAU) groups for six months with an interim and a final review. Data were collected on feasibility, health service usage, function, quality of life, loneliness, and participants' experience and perception of the intervention. Non-parametric tests were used to analyse within and between-group differences. P-values were adjusted to account for type I error. Thematic analysis of qualitative data was conducted.ResultsOne hundred sixty four older adults were invited to participate, of which 44.5% (n = 72) were randomised to either the TAU (n = 37) or intervention (n = 35) groups. All participants in the intervention group were given the baseline, interim and final reviews. Eight participants in each group were lost to post-intervention outcome assessment. The health service use (i.e. hospital admissions, GP/emergency calls and GP/Accident Emergency attendance) was slightly higher in the TAU group; however, none of the outcome data showed statistical significance between-group differences. The TAU group showed a deterioration in the total functional independence and its motor and cognition components post-intervention (p < .05), though the role limitation due to physical function and pain outcomes improved (p < .05). The qualitative findings indicate that participants appreciated the consistency of care provided by ANPs, experienced positive therapeutic relationship and were connected to wider services.DiscussionFrailty identification and intervention delivery in the community by ANPs were feasible. The study shows that older adults with frailty living in the community might benefit from intervention delivered by ANPs. It is suggested to examine the cost-effectiveness of the intervention in sufficiently powered future research.Trial registrationsThe protocol is available at clinicaltirals.gov, ID: NCT03394534; 09/01/2018.

Dataset Information

HELPing older people with very severe chronic obstructive pulmonary disease (HELP-COPD): mixed-method feasibility pilot randomised controlled trial of a novel intervention.

Publications

HELPing older people with very severe chronic obstructive pulmonary disease (HELP-COPD): mixed-method feasibility pilot randomised controlled trial of a novel intervention.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets