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Results for 'randomised controlled trials'

Results 1 - 10 of 17

The Community Navigator Study: results from a feasibility randomised controlled trial of a programme to reduce loneliness for people with complex anxiety or depression

BRYNMOR Lloyd-Evans, et al

Background: Loneliness is common among people with mental health problems and predicts poorer recovery from depression and anxiety. Needs for support with loneliness and social relationships are often under-addressed in mental health services. The Community Navigator programme was designed to reduce loneliness for adults (aged 18 and above) with complex depression or anxiety who were using secondary mental health services. Acceptability and feasibility of the programme and a trial evaluation were tested in a feasibility randomised controlled trial with qualitative evaluation. Methods: Forty participants with depression or anxiety using secondary mental health services were recruited from mental health services in two London sites and randomised to receive: the Community Navigator programme over six months in addition to routine care (n = 30); or routine care (n = 10). Measures of loneliness, depression, other clinical and social outcomes and service use were collected at baseline and six-months follow-up. Levels of engagement in the programme and rates of trial recruitment and retention were assessed. Programme delivery was assessed through session logs completed by Community Navigators. The acceptability of the programme was explored through qualitative interviews (n = 32) with intervention group participants, their family and friends, programme providers and other involved staff. Results: Forty participants were recruited in four months from 65 eligible potential participants asked. No one withdrew from the trial. Follow-up interviews were completed with 35 participants (88%). Process records indicated the programme was delivered as intended: there was a median of seven meetings with their Community Navigator (of a maximum ten) per treatment group participant. Qualitative interviews indicated good acceptability of the programme to stakeholders, and potential utility in reducing loneliness and depression and anxiety. Conclusions: A definitive, multi-site randomised controlled trial is recommended to evaluate the effectiveness and cost-effectiveness of the Community Navigator programme for people with complex anxiety and depression in secondary mental health services.

Video calls for reducing social isolation and loneliness in older people: a rapid review (Review)

NOONE Chris, et al

A rapid review to assess the effectiveness of video calls for reducing social isolation and loneliness in older adults. The review also sought to address the effectiveness of video calls on reducing symptoms of depression and improving quality of life. Selection criteria: Randomised controlled trials (RCTs) and quasi‐RCTs (including cluster designs) were eligible for inclusion. Main results: Three cluster quasi-randomised trials, which together included 201 participants were included in this review. The included studies compared video call interventions to usual care in nursing homes. None of these studies were conducted during the COVID-19 pandemic. Each study measured loneliness using the UCLA Loneliness Scale. The evidence was very uncertain and suggests that video calls may result in little to no difference in scores on the Geriatric Depression Scale compared to usual care at three months' follow-up. Conclusion: Based on this review there is currently very uncertain evidence on the effectiveness of video call interventions to reduce loneliness in older adults. The review did not include any studies that reported evidence of the effectiveness of video call interventions to address social isolation in older adults. The evidence regarding the effectiveness of video calls for outcomes of symptoms of depression was very uncertain. Future research in this area needs to use more rigorous methods and more diverse and representative participants.

Home modifications to reduce injuries from falls in the Home Injury Prevention Intervention (HIPI) study: a cluster-randomised controlled trial

KEALL Michael D, et al

Background: Despite the considerable injury burden attributable to falls at home among the general population, few effective safety interventions have been identified. This study tested the safety benefits of home modifications, including handrails for outside steps and internal stairs, grab rails for bathrooms, outside lighting, edging for outside steps, and slip-resistant surfacing for outside areas such as decks and porches. Methods: This study is a single-blind, cluster-randomised controlled trial of households from the Taranaki region of New Zealand. To be eligible, participants had to live in an owner-occupied dwelling constructed before 1980 and at least one member of every household had to be in receipt of state benefits or subsidies. This study randomly assigned households by electronic coin toss to either immediate home modifications (treatment group) or a 3-year wait before modifications (control group). Household members in the treatment group could not be masked to their assigned status because modifications were made to their homes. The primary outcome was the rate of falls at home per person per year that needed medical treatment, which was derived from administrative data for insurance claims. Coders who were unaware of the random allocation analysed text descriptions of injuries and coded injuries as all falls and injuries most likely to be affected by the home modifications tested. To account for clustering at the household level, this stanalysed all injuries from falls at home per person-year with a negative binomial generalised linear model with generalised estimating equations. Analysis was by intention to treat. This trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12609000779279. Findings: Of 842 households recruited, 436 (n=950 individual occupants) were randomly assigned to the treatment group and 406 (n=898 occupants) were allocated to the control group. After a median observation period of 1148 days (IQR 1085–1263), the crude rate of fall injuries per person per year was 0·061 in the treatment group and 0·072 in the control group (relative rate 0·86, 95% CI 0·66–1·12). The crude rate of injuries specific to the intervention per person per year was 0·018 in the treatment group and 0·028 in the control group (0·66, 0·43–1·00). A 26% reduction in the rate of injuries caused by falls at home per year exposed to the intervention was estimated in people allocated to the treatment group compared with those assigned to the control group, after adjustment for age, previous falls, sex, and ethnic origin (relative rate 0·74, 95% CI 0·58–0·94). Injuries specific to the home-modification intervention were cut by 39% per year exposed (0·61, 0·41–0·91). Interpretation: The findings suggest that low-cost home modifications and repairs can be a means to reduce injury in the general population. Further research is needed to identify the effectiveness of particular modifications from the package tested.

Cost-effectiveness of telecare for people with social care needs: the Whole Systems Demonstrator cluster randomised trial

HENDERSON Catherine, et al

Purpose of the study: to examine the costs and cost-effectiveness of ‘second-generation’ telecare, in addition to standard support and care that could include ‘first-generation’ forms of telecare, compared with standard support and care that could include ‘first-generation’ forms of telecare. Design and methods: a pragmatic cluster-randomised controlled trial with nested economic evaluation. A total of 2,600 people with social care needs participated in a trial of community-based telecare in three English local authority areas. In the Whole Systems Demonstrator Telecare Questionnaire Study, 550 participants were randomised to intervention and 639 to control. Participants who were offered the telecare intervention received a package of equipment and monitoring services for 12 months, additional to their standard health and social care services. The control group received usual health and social care. Primary outcome measure: incremental cost per quality-adjusted life year (QALY) gained. The analyses took a health and social care perspective. Results: cost per additional QALY was £297,000. Cost-effectiveness acceptability curves indicated that the probability of cost-effectiveness at a willingness-to-pay of £30,000 per QALY gained was only 16%. Sensitivity analyses combining variations in equipment price and support cost parameters yielded a cost-effectiveness ratio of £161,000 per QALY. Implications: while QALY gain in the intervention group was similar to that for controls, social and health services costs were higher. Second-generation telecare did not appear to be a cost-effective addition to usual care, assuming a commonly accepted willingness to pay for QALYs.

Interventions for preventing falls in older people living in the community (review)

GILLESPIE Lesley D., et al

Background: Approximately 30 per cent of people over 65 years of age living in the community fall each year. This is an update of a Cochrane review first published in 2009.Objective: To assess the effects of interventions designed to reduce the incidence of falls in older people living in the community. Search methods: this review searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (February 2012), CENTRAL (The Cochrane Library2012, Issue 3), MEDLINE (1946 to March 2012), EMBASE (1947 to March 2012), CINAHL (1982 to February 2012), and online trial registers. Selection criteria: Randomised trials of interventions to reduce falls in community-dwelling older people. Main results: this review included 159 trials with 79,193 participants. Most trials compared a fall prevention intervention with no intervention or an intervention not expected to reduce falls. The most common interventions tested were exercise as a single intervention (59 trials) and multifactorial programmes (40 trials). Findings: Group and home‐based exercise programmes, usually containing some balance and strength training exercises, effectively reduced falls, as did Tai Chi. Overall, exercise programmes aimed at reducing falls appear to reduce fractures. Multifactorial interventions assess an individual's risk of falling, and then carry out treatment or arrange referrals to reduce the identified risks. Overall, current evidence shows that this type of intervention reduces the number of falls in older people living in the community but not the number of people falling during follow‐up. These are complex interventions, and their effectiveness may be dependent on factors yet to be determined. Interventions to improve home safety appear to be effective, especially in people at higher risk of falling and when carried out by occupational therapists. An anti‐slip shoe device worn in icy conditions can also reduce falls. Taking vitamin D supplements does not appear to reduce falls in most community‐dwelling older people, but may do so in those who have lower vitamin D levels in the blood before treatment. Some medications increase the risk of falling. Three trials in this review failed to reduce the number of falls by reviewing and adjusting medications. A fourth trial involving family physicians and their patients in medication review was effective in reducing falls. Gradual withdrawal of a particular type of drug for improving sleep, reducing anxiety, and treating depression (psychotropic medication) has been shown to reduce falls. Cataract surgery reduces falls in women having the operation on the first affected eye. Insertion of a pacemaker can reduce falls in people with frequent falls associated with carotid sinus hypersensitivity, a condition which causes sudden changes in heart rate and blood pressure. In people with disabling foot pain, the addition of footwear assessment, customised insoles, and foot and ankle exercises to regular podiatry reduced the number of falls but not the number of people falling. The evidence relating to the provision of educational materials alone for preventing falls is inconclusive.

The effectiveness of interventions for reducing subjective and objective social isolation among people with mental health problems: a systematic review

MA Ruimin, et al

Purpose: Subjective and objective social isolation are important factors contributing to both physical and mental health problems, including premature mortality and depression. This systematic review evaluated the current evidence for the effectiveness of interventions to improve subjective and/or objective social isolation for people with mental health problems. Primary outcomes of interest included loneliness, perceived social support, and objective social isolation. Methods: Three databases were searched for relevant randomised controlled trials (RCTs). Studies were included if they evaluated interventions for people with mental health problems and had objective and/or subjective social isolation (including loneliness) as their primary outcome, or as one of a number of outcomes with none identified as primary. Results: In total, 30 RCTs met the review’s inclusion criteria: 15 included subjective social isolation as an outcome and 11 included objective social isolation. The remaining four evaluated both outcomes. There was considerable variability between trials in types of intervention and participants’ characteristics. Significant results were reported in a minority of trials, but methodological limitations, such as small sample size, restricted conclusions from many studies. Conclusion: The evidence is not yet strong enough to make specific recommendations for practice. Preliminary evidence suggests that promising interventions may include cognitive modification for subjective social isolation, and interventions with mixed strategies and supported socialisation for objective social isolation. This study highlights the need for more thorough, theory-driven intervention development and for well-designed and adequately powered RCTs.

The impact of telehealth on use of hospital care and mortality: research summary


The impact of telehealth on hospital use, patient admission and mortality were evaluated in three trial sites in England. The sites were from the Department of Health’s Whole System Demonstrator pilots. The evaluation focused on the use of telehealth to people with chronic obstructive pulmonary disease, diabetes or heart failure. It used a large randomised controlled trial which included over 3,000 participants (1,584 control and 1,570 intervention) in which groups of patients either received the telehealth intervention or acted as controls by receiving their usual care. Statistically significant differences in rates of emergency hospital admission and mortality were found during the twelve months of the trial between control and intervention groups. For intervention patients, the overall costs of hospital care (including emergency admissions, elective admissions and outpatient attendances) were £188 per patient less than those for controls. However, this cost difference was not statistically significant. As well as summarising the main findings the research summary highlights the limitations of the research and other issues that need to be considered in relation to the findings.

Impact of individualised music listening intervention on persons with dementia: A systematic review of randomised controlled trials

GAVIOLA Minah Amor, et al

Objective: To summarise the evidence regarding the impact of individualised music listening on persons with dementia. Methods: Six electronic databases (CINAHL, Medline, ProQuest, PsycINFO, Music Periodicals and Cochrane) were searched up to July 2018 for randomised controlled trials (RCTs) evaluating the efficacy of individualised music listening compared to other music and non–music‐based interventions. Results: Four studies were included. Results showed evidence of a positive impact of individualised music listening on behavioural and psychological symptoms of dementia (BPSDs) including agitation, anxiety and depression and physiological outcomes. Evidence for other outcomes such as cognitive function and quality of life was limited. Conclusions: The limited evidence suggests individualised music listening has comparable efficacy to more resource‐intensive interventions. However, there was a small number of RCTs and some outcomes were evaluated by a single study. This limits the conclusions drawn, warranting more RCTs evaluating other outcomes beyond the BPSDs.

Health at home: a new health and wellbeing model for social housing tenants


Explores how housing support services and community-based health services can deliver effective services at lower cost; encourage self-care for the most vulnerable customers and reduce dependency on direct support; work with other agencies to ensure a coordinated response to the residents’ complex and multiple health needs. The report sets out the findings of a study which aimed to test a person-centred support model using a randomised control trial of 261 general needs residents aged over 50. The service model employed health navigators and volunteers to coach and connect residents with the relevant health, housing and community services they need. The study used to measurement tools to assess impact: the Patient Activation Measure (PAM) and Coaching for Activation (CFA). The study found that three months of intervention with those who started in PAM Level 2 was sufficient to move them up, on average, an entire PAM level. This increase in activation was sustained for at least nine months after the intervention ended, suggesting that participants gained the skills and confidence to effectively manage their health without further support after the initial intensive intervention. This is significant as one of the largest studies into cost reductions from PAM level changes in the United States found that patients who moved from Level 2 to Level 3 reduced their annual healthcare costs by 12%. Existing evidence also indicates that when people become more active in self-care, they benefit from better health outcomes, and fewer unplanned health admissions. The report concludes that there is a clear and compelling case for continuing to support integrated care and strengthen links between the health and housing agendas.

Precious memories: a randomized controlled trial on the effects of an autobiographical memory intervention delivered by trained volunteers in residential care homes

WESTERHO Gerben J., et al

Objectives: This study assesses the effects of an autobiographical memory intervention on the prevention and reduction of depressive symptoms in older persons in residential care. Trained volunteers delivered the intervention. Methods: A randomized controlled trial was carried out with depressive symptoms as the primary outcome. The experimental condition received the intervention Precious Memories one-on-one, whereas the control condition had individual unstructured contacts with a volunteer. Participants were 86 older persons living in residential care. There were three measurements: pre-intervention, post-intervention (2 months after the first measurement), and follow-up (8 months after the first measurement). Besides depressive symptoms, the retrieval of specific positive memories was measured as a process variable. Anxiety, loneliness, well-being, and mastery were assessed as secondary outcomes. Results: Depressive symptoms improved equally in the intervention and the control condition at post-measurement. Participants with clinically relevant depressive symptoms also maintained the effects at follow-up in both conditions. The retrieval of specific positive memories improved more in the autobiographical memory intervention, although this was not maintained at follow-up. Anxiety and loneliness improved equally well in both conditions, but no effects were found for well-being or mastery. Conclusion: It is concluded that volunteers can deliver the intervention and contribute to the mental health of this highly vulnerable group of older adults.

Results 1 - 10 of 17


Moving Memory

Moving Memory Practice example about how the Moving Memory Dance Theatre Company is challenging perceived notions of age and ageing.

Chatty Cafe Scheme

Chatty Cafe Scheme Practice example about how the Chatty Cafe Scheme is helping to tackle loneliness by bringing people of all ages together

Oomph! Wellness

Oomph! Wellness Practice example about how Oomph! Wellness is supporting staff to get older adults active and combat growing levels of social isolation


KOMP Practice example about how KOMP, designed by No Isolation is helping older people stay connected with their families

LAUGH research project

LAUGH research project Practice example about a research project to develop highly personalised, playful objects for people with advanced dementia
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