Chair-based yoga programme for older adults with multimorbidity: RCT with embedded economic and process evaluations.

Background: Older adults with multimorbidity experience impaired health-related quality of life and treatment burden. Yoga has the potential to improve several aspects of health and well-being. The British Wheel of Yoga's Gentle Years Yoga© programme was developed specifically for older adults, including those with chronic conditions. A pilot trial demonstrated feasibility of using Gentle Years Yoga in this population, but there was limited evidence of its effectiveness and cost-effectiveness. Objective: To determine the effectiveness and cost-effectiveness of the Gentle Years Yoga programme in addition to usual care versus usual care alone in older adults with multimorbidity. Design: Pragmatic, multisite, individually randomised controlled trial with embedded economic and process evaluations. Setting: Participants were recruited from 15 general practices in England and Wales from July 2019 with final follow-up in October 2022. Participants: Community-dwelling adults aged 65 years and over with multimorbidity, defined as two or more chronic health conditions from a predefined list. Interventions: All participants continued with any usual care provided by primary, secondary, community and social services. The intervention group was offered a 12-week programme of Gentle Years Yoga. Main outcome measures: The primary outcome and end point were health-related quality of life measured using the EuroQol-5 Dimensions, five-level version utility index score over 12 months. Secondary outcomes were health-related quality of life, depression, anxiety, loneliness, incidence of falls, adverse events and healthcare resource use. Results: The mean age of the 454 randomised participants was 73.5 years; 60.6% were female, and participants had a median of three chronic conditions. The primary analysis included 422 participants (intervention, n = 227 of 240, 94.6%; usual care, n = 195 of 214, 91.1%). There was no statistically or clinically significant difference in the EuroQol-5 Dimensions, five-level version utility index score over 12 months: the predicted mean score for the intervention group was 0.729 (95% confidence interval 0.712 to 0.747) and for usual care it was 0.710 [95% confidence interval (CI) 0.691 to 0.729], with an adjusted mean difference of 0.020 favouring intervention (95% CI -0.006 to 0.045, p = 0.14). No statistically significant differences were observed in secondary outcomes, except for the pain items of the Patient-Reported Outcomes Measurement Information System-29. No serious, related adverse events were reported. The intervention cost £80.85 more per participant (95% CI £76.73 to £84.97) than usual care, generated an additional 0.0178 quality-adjusted life-years per participant (95% CI 0.0175 to 0.0180) and had a 79% probability of being cost-effective at the National Institute for Health and Care Excellence threshold of £20,000 per quality-adjusted life-year gained. The intervention was acceptable to participants, with seven courses delivered face to face and 12 online. Limitations: Self-reported outcome data raise the potential for bias in an unblinded trial. The COVID-19 pandemic affected recruitment, follow-up and the mode of intervention delivery. Conclusions: Although the Gentle Years Yoga programme was not associated with any statistically significant benefits in terms of health-related quality of life, mental health, loneliness or falls, the intervention was safe, acceptable to most participants and highly valued by some. The economic evaluation suggests that the intervention could be cost-effective. Future work: Longer-term cost-effectiveness modelling and identifying subgroups of people who are most likely to benefit from this type of intervention. Trial registration: This trial is registered as ISRCTN13567538. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 17/94/36) and is published in full in Health Technology Assessment; Vol. 28, No. 53. See the NIHR Funding and Awards website for further award information.

It is common for older adults to have two or more long-term health conditions. These conditions affect quality of life differently, with some people feeling well and others needing healthcare support. The Gentle Years Yoga programme was developed to improve quality of life for older adults, including those with long-term health conditions. We wanted to see how well the programme worked and if it offered good value for money for the NHS. We tested whether offering a 12-week course of Gentle Years Yoga improved the quality of life and reduced anxiety, depression, loneliness and falls for people aged 65 years and over who had two or more long-term health conditions. We recruited 454 people through general practices across England and Wales, with 240 people selected at random to be invited to take part in the Gentle Years Yoga programme and the other 214 to continue with their usual care and not be offered Gentle Years Yoga. The average age of participants was 74 years, nearly two-thirds were female and the number of long-term health conditions participants had ranged from two to nine (average was three). They completed four questionnaires over a 12-month period. We also interviewed some of the participants and the yoga teachers to find out how the approach worked in practice. The yoga was delivered either face to face or online. We did not find any significant benefits in terms of quality of life, anxiety, depression, loneliness or falls. At interview, some yoga participants noted no or a modest impact on their health or lifestyle, while others described Gentle Years Yoga as transformative, having substantial impacts and improvements on their physical health and emotional well-being. Because running the yoga classes was relatively inexpensive and some insignificant benefits were seen, the Gentle Years Yoga programme may be good value for money.

Effectiveness and cost-effectiveness of offering a chair-based yoga programme in addition to usual care in older adults with multiple long-term conditions: a pragmatic, parallel group, open label, randomised controlled trial.

Background: People with multiple long-term conditions are more likely to have poorer health-related quality of life (HRQOL). Yoga has the potential to improve HRQOL. Gentle Years Yoga© (GYY) is a chair-based yoga programme for older adults. We investigated the effectiveness and cost-effectiveness of the GYY programme in older adults with multiple long-term conditions. Methods: In this pragmatic, multi-site, open, randomised controlled trial, we recruited adults aged ≥65 years with ≥2 long-term conditions from 15 primary care practices in England and Wales. Participants were randomly assigned to usual care control or a 12-week, group-based, GYY programme delivered face-to-face or online by qualified yoga teachers. The primary outcome was HRQOL (EQ-5D-5L) over 12 months. Secondary outcomes included anxiety, depression, falls, loneliness, healthcare resource use, and adverse events. Results: Between October 2019 and October 2021, 454 participants were randomised between the intervention (n=240) and control (n=214) groups. Seven GYY courses were delivered face-to-face and 12 courses were delivered online. The mean number of classes attended among all intervention participants was nine (SD 4, median 10). In our intention-to-treat analysis (n=422), there was no statistically significant difference between trial groups in the primary outcome of HRQOL (adjusted difference in mean EQ-5D-5L = 0.020 [favouring intervention]; 95% CI -0.006 to 0.045, p=0.14). There were also no statistically significant differences in key secondary outcomes. No serious, related adverse events were reported. The incremental cost-effectiveness ratio was £4,546 per quality-adjusted life-year (QALY) and the intervention had a 79% probability of being cost-effective at a willingness-to-pay threshold of £20,000 per QALY. The intervention was acceptable to most participants and perceived as useful by some. Conclusions: The offer of a 12-week chair-based yoga programme in addition to usual care did not improve HRQOL in older adults with multiple long-term conditions. However, the intervention was safe, acceptable, and probably cost-effective.

Enclosing a pen in a postal questionnaire follow-up to increase response rate: a study within a trial.

Background: Poor response rates to follow-up questionnaires can adversely affect the progress of a randomised controlled trial and the validity of its results. This embedded 'study within a trial' aimed to investigate the impact of including a pen with the postal 3-month questionnaire completed by the trial participants on the response rates to this questionnaire. Methods: This study was a two-armed randomised controlled trial nested in the Gentle Years Yoga (GYY) trial. Participants in the intervention group of the GYY trial were allocated 1:1 using simple randomisation to either receive a pen (intervention) or no pen with their 3-month questionnaire (control). The primary outcome was the proportion of participants sent a 3-month questionnaire who returned it. Secondary outcomes were time taken to return the questionnaire, proportion of participants sent a reminder to return the questionnaire, and completeness of the questionnaire. Binary outcomes were analysed using logistic regression, time to return by Cox Proportional Hazards regression and number of items completed by linear regression. Results: There were 111 participants randomised to the pen group and 118 to the no pen group who were sent a 3-month questionnaire. There was no evidence of a difference in return rates between the two groups (pen 107 (96.4%), no pen 117 (99.2%); OR 0.23, 95% CI 0.02 to 2.19, p=0.20). Furthermore, there was no evidence of a difference between the two groups in terms of time to return the questionnaire (HR 0.90, 95% CI 0.69 to 1.18, p=0.47), the proportion of participants sent a reminder (OR 0.85, 95% CI 0.48 to 1.53, p=0.60) nor the number of items completed (mean difference 0.51, 95% CI -0.04 to 1.06, p=0.07). Conclusion: The inclusion of a pen with the postal 3-month follow-up questionnaire did not have a statistically significant effect on response rate.

Yoga for older adults with multimorbidity (the Gentle Years Yoga Trial): study protocol for a randomised controlled trial.

BACKGROUND: Multimorbidity is common in older adults and associated with high levels of illness burden and healthcare expenditure. The evidence base for how to manage older adults with multimorbidity is weak. Yoga might be a useful intervention because it has the potential to improve health-related quality of life, physical functioning, and several medical conditions. The British Wheel of Yoga's Gentle Years Yoga© (GYY) programme was developed specifically for older adults, including those with chronic medical conditions. Data from a pilot trial suggested feasibility of using GYY in this population, but its effectiveness and cost-effectiveness remain uncertain. METHODS: This is a multi-site, individually randomised, superiority trial with an embedded process evaluation and an economic analysis of cost-effectiveness. The trial will compare an experimental strategy of offering a 12-week GYY programme against a control strategy of no offer in community-dwelling adults aged 65 or over who have multimorbidity, defined as having two or more chronic conditions from a predefined list. The primary outcome is health-related quality of life measured using the EQ-5D-5L, the primary endpoint being the overall difference over 12 months. Both groups will continue to be able to access their usual care from primary, secondary, community, and social services. Participants, care providers, and yoga teachers will not be blinded to the allocated intervention. Outcome measures are primarily self-reported. The analysis will follow intention-to-treat principles. DISCUSSION: This pragmatic randomised controlled trial will demonstrate if the GYY programme is an effective, cost-effective, and viable addition to the management of older adults with multimorbidity. TRIAL REGISTRATION: ISRCTN ISRCTN13567538 . Registered on 18 March 2019.

A 2x2 randomised factorial SWAT of the use of a pen and small, financial incentive to improve recruitment in a randomised controlled trial of yoga for older adults with multimorbidity.

Background: Monetary and other incentives may increase recruitment to randomised controlled trials. Methods: This was a 2x2 factorial 'study within a trial' of including a pen and/or £5 with a postal recruitment pack to improve randomisation rate (primary outcome) into the host Gentle Years Yoga trial in older adults with multimorbidity. Secondary outcomes: return, and time to return, of screening form, and the cost per additional participant recruited. Binary data were analysed using logistic regression and time to return data using Cox proportional hazards regression.  Results: 818 potential host trial participants included. Between those sent a pen (n=409) and not sent a pen (n=409), there was no evidence of a difference in the likelihood of being randomised (15 (3.7%) versus 11 (2.7%); OR 1.38, 95% CI 0.63-3.04), in returning a screening form (66 (16.1%) versus 61 (14.9%); OR 1.10, 95% CI 0.75-1.61) nor in time to return the screening form (HR 1.09, 95% CI 0.77-1.55). There was evidence of improved screening return rates (77 (18.8%) versus 50 (12.2%); OR 1.67, 95% CI 1.13-2.45) and time to return screening form (HR 1.56, 95% CI 1.09-2.22) but not randomisation (14 (3.4%) versus 12 (2.9%); OR 1.18, 95% CI 0.54-2.57) in those sent £5 (n=409) compared with those not sent £5 (n=409). No significant interaction effects between the interventions were observed. The cost per additional participant recruited was £32 for the pen and £1000 for the £5 incentive. Conclusion: Including a small, monetary incentive encouraged increased and faster response to the recruitment invitation but did not result in more participants being randomised into the host trial. Since it is relatively costly, we do not recommend this intervention for use to increase recruitment in this population. Pens are cheaper but did not provide evidence of benefit. Further studies may be required.

Adapted yoga to improve physical function and health-related quality of life in physically-inactive older adults: a randomised controlled pilot trial.

BACKGROUND: Yoga is a holistic therapy of expanding popularity, which has the potential to produce a range of physical, mental and social benefits. This trial evaluated the feasibility and effects of an adapted yoga programme on physical function and health-related quality of life in physically-inactive older adults. METHODS: In this randomised controlled pilot trial, 52 older adults (90% female; mean age 74.8 years, SD 7.2) were randomised 1:1 to a yoga programme or wait-list control. The yoga group (n = 25) received a physical activity education booklet and were invited to attend ten yoga sessions during a 12-week period. The control group (n = 27) received the education booklet only. Measures of physical function (e.g., Short Physical Performance Battery; SPPB), health status (EQ-5D) and mental well-being (Warwick-Edinburgh Mental Well-being Scale; WEMWBS) were assessed at baseline and 3 months. Feasibility was assessed using course attendance and adverse event data, and participant interviews. RESULTS: Forty-seven participants completed follow-up assessments. Median class attendance was 8 (range 3 to 10). At the 3-month follow-up, the yoga group had a higher SPPB total score compared with the control group (mean difference 0.9, 95% confidence interval [CI] -0.3 to 2.0), a faster time to rise from a chair five times (mean difference - 1.73 s, 95% CI -4.08 to 0.62), and better performance on the chair sit-and-reach lower-limb flexibility test (mean difference 5 cm, 95% CI 0 to 10). The yoga group also had superior health status and mental well-being (vs. control) at 3 months, with mean differences in EQ-5D and WEMWBS scores of 0.12 (95% CI, 0.03 to 0.21) and 6 (95% CI, 1 to 11), respectively. The interviews indicated that participants valued attending the yoga programme, and that they experienced a range of benefits. CONCLUSIONS: The adapted yoga programme appeared to be feasible and potentially beneficial in terms of improving mental and social well-being and aspects of physical function in physically-inactive older adults. An appropriately-powered trial is required to confirm the findings of the present study and to determine longer-term effects. TRIAL REGISTRATION: ClinicalTrials.gov NCT02663726 .

Caring at home until death: enabled determination.

PURPOSE: The importance of family caregivers in providing palliative care at home and in supporting a home death is well supported. Gaining a better understanding of what enables palliative family caregivers to continue caring at home for their family members until death is critical to providing direction for more effective support. The purpose of the study was to describe the experiences of bereaved family caregivers whose terminally ill family members with advanced cancer were successful in achieving a desired home death. METHOD: A qualitative interpretive descriptive approach was used. Data were collected using semi-structured, audio-recorded interviews conducted in-person or via telephone in addition to field notes and reflective journaling. The study took place in British Columbia, Canada, and included 29 bereaved adult family caregivers who had provided care for a family member with advanced cancer and experienced a home death. RESULTS: Four themes captured the experience of caring at home until death: context of providing care, supportive antecedents to providing care, determination to provide care at home, and enabled determination. Factors that enabled determination to achieve a home death included initiation of formal palliative care, asking for and receiving help, augmented care, relief or respite, and making the healthcare system work for the ill person. CONCLUSIONS: Clarifying caregiving goals and supporting the factors that enable caregiver determination appear to be critical in enhancing the likelihood of a desired home death.

A social media approach to inform youth about breast cancer and smoking: an exploratory descriptive study.

Tobacco exposure during periods of breast development has been shown to increase risk of premenopausal breast cancer. An urgent need exists, therefore, to raise awareness among adolescent girls about this new evidence, and for adolescent girls and boys who smoke to understand how their smoking puts their female peers at risk for breast cancer. The purpose of this study was to develop two youth-informed, gender specific YouTube-style videos designed to raise awareness among adolescent girls and boys about tobacco exposure as a modifiable risk factor for breast cancer and to assess youths' responses to the videos and their potential for inclusion on social media platforms. Both videos consisted of a combination of moving text, novel images, animations, and youth-friendly music. A brief questionnaire was used to gather feedback on two videos using a convenience sample of 135 youth in British Columbia, Canada. The overall positive responses by girls and boys to their respective videos and their reported interest in sharing these videos via social networking suggests that this approach holds potential for other types of health promotion messaging targeting youth. The videos offer a promising messaging strategy for raising awareness about tobacco exposure as a modifiable risk factor for breast cancer. Tailored, gender-specific messages for use on social media hold the potential for cost-effective, health promotion and cancer prevention initiatives targeting youth.

Designing Tailored Messages about Smoking and Breast Cancer: A Focus Group Study with Youth.

The purpose of this study was to design an approach to supporting the development of gender- and Aboriginal-specific messages regarding the link between tobacco exposure and breast cancer, drawing on youth perspectives. Focus groups were held with 18 girls (8 First Nations and Métis) and 25 boys (12 First Nations and Métis) to solicit advice in the design of messages. Transcribed data were analyzed for themes. Girls preferred messages that included the use of novel images, a personal story of breast cancer, and ways to avoid secondhand smoke. Boys endorsed messages that were "catchy" but not "cheesy" and had masculine themes. First Nations and Métis participants confirmed the use of Aboriginal symbols in messages as signalling their relevance to youth in their communities. The results can be used as a guide in developing tailored health promotion messages. Challenges in developing gender-appropriate messages for youth are described.

Notre étude visait à mettre au point une approche propice à la création de messages axés sur le lien entre l'exposition au tabac et le cancer du sein, qui s'adresseraient aux jeunes Autochtones de chaque sexe et s'inspireraient de leurs perspectives. Nous avons tenu des groupes de discussion formés de 18 filles (issues de huit Premières nations et du peuple métis) et de 25 garçons (issus de 12 Premières nations et du peuple métis), dans le but d'obtenir leur avis sur cette question. Les données transcrites ont été analysées pour en dégager les thèmes principaux. Chez les filles, on préfère des messages qui proposent des images originales, une histoire personnelle sur le cancer du sein et des conseils sur les façons d'éviter de s'exposer à la fumée secondaire. Les garçons préfèrent quant à eux des messages « accrocheurs ¼, qui ne sont pas « de mauvais goût ¼ et comportent des thèmes masculins. Tous et toutes ont jugé que le recours à des symboles autochtones dans les messages était pertinent pour les jeunes de leurs communautés. Ces résultats pourront servir de guide en vue de créer des messages ciblés axés sur la promotion de la santé. On explique les difficultés que présente la formulation de messages adaptés en fonction du sexe des jeunes.

The Older Persons' Transitions in Care (OPTIC) study: pilot testing of the transition tracking tool.

BACKGROUND: OPTIC is a mixed method Partnership for Health System Improvement (http://www.cihr-irsc.gc.ca/e/34348.html) study focused on improving care for nursing home (NH) residents who are transferred to and from emergency departments (EDs) via emergency medical services (EMS). In the pilot study we tested feasibility of concurrently collecting individual resident data during transitions across settings using the Transition Tracking Tool (T3). METHODS: The pilot study tracked 54 residents transferred from NHs to one of two EDs in two western Canadian provinces over a three month period. The T3 is an electronic data collection tool developed for this study to record data relevant to describing and determining success of transitions in care. It comprises 800+ data elements including resident characteristics, reasons and precipitating factors for transfer, advance directives, family involvement, healthcare services provided, disposition decisions, and dates/times and timing. RESULTS: Residents were elderly (mean age = 87.1 years) and the majority were female (61.8%). Feasibility of collecting data from multiple sources across two research sites was established. We identified resources and requirements to access and retrieve specific data elements in various settings to manage data collection processes and allocate research staff resources. We present preliminary data from NH, EMS, and ED settings. CONCLUSIONS: While most research in this area has focused on a unidirectional process of patient progression from one care setting to another, this study established feasibility of collecting detailed data from beginning to end of a transition across multiple settings and in multiple directions.

Perceptions of cannabis as a stigmatized medicine: a qualitative descriptive study.

BACKGROUND: Despite its increasing prevalence and acceptance among the general public, cannabis use continues to be viewed as an aberrant activity in many contexts. However, little is known about how stigma associated with cannabis use affects individuals who use cannabis for therapeutic purposes (CTP) and what strategies these individuals employ to manage associated stigma. The aim of this Canadian study was to describe users' perceptions of and responses to the stigma attached to using CTP. METHODS: Twenty-three individuals who were using CTP for a range of health problems took part in semi-structured interviews. Transcribed data were analyzed using an inductive approach and comparative strategies to explore participants' perceptions of CTP and identify themes. RESULTS: Participant experiences of stigma were related to negative views of cannabis as a recreational drug, the current criminal sanctions associated with cannabis use, and using cannabis in the context of stigmatizing vulnerability (related to existing illness and disability). Strategies for managing the resulting stigma of using CTP included: keeping CTP 'undercover'; educating those who did not approve of or understand CTP use; and using cannabis responsibly. CONCLUSIONS: Understanding how individuals perceive and respond to stigma can inform the development of strategies aimed at reducing stigma associated with the use of CTP and thereby address barriers faced by those using this medicine.

Older Persons' Transitions in Care (OPTIC): a study protocol.

BACKGROUND: Changes in health status, triggered by events such as infections, falls, and geriatric syndromes, are common among nursing home (NH) residents and necessitate transitions between NHs and Emergency Departments (EDs). During transitions, residents frequently experience care that is delayed, unnecessary, not evidence-based, potentially unsafe, and fragmented. Furthermore, a high proportion of residents and their family caregivers report substantial unmet needs during transitions. This study is part of a program of research whose overall aim is to improve quality of care for frail older adults who reside in NHs. The purpose of this study is to identify successful transitions from multiple perspectives and to identify organizational and individual factors related to transition success, in order to inform improvements in care for frail elderly NH residents during transitions to and from acute care. Specific objectives are to: 1. define successful and unsuccessful elements of transitions from multiple perspectives; 2. develop and test a practical tool to assess transition success; 3. assess transition processes in a discrete set of transfers in two study sites over a one year period; 4. assess the influence of organizational factors in key practice locations, e.g., NHs, emergency medical services (EMS), and EDs, on transition success; and 5. identify opportunities for evidence-informed management and quality improvement decisions related to the management of NH - ED transitions. METHODS/DESIGN: This is a mixed-methods observational study incorporating an integrated knowledge translation (IKT) approach. It uses data from multiple levels (facility, care unit, individual) and sources (healthcare providers, residents, health records, and administrative databases). DISCUSSION: Key to study success is operationalizing the IKT approach by using a partnership model in which the OPTIC governance structure provides for team decision-makers and researchers to participate equally in developing study goals, design, data collection, analysis and implications of findings. As preliminary and ongoing study findings are developed, their implications for practice and policy in study settings will be discussed by the research team and shared with study site administrators and staff. The study is designed to investigate the complexities of transitions and to enhance the potential for successful and sustained improvement of these transitions.

Health effects of using cannabis for therapeutic purposes: a gender analysis of users' perspectives.

The purpose of this qualitative study was to describe how individuals who self-report therapeutic use of cannabis perceive its health effects. Data from 23 individual interviews were transcribed and analyzed. Understandings of gendered roles and identities were used to explore the data and interpret differences in perceptions. Descriptions of the health benefits of cannabis for therapeutic purposes included cannabis as life preserving, a disease therapy, a medicine for the mind, a means for self-management, and a way to manage addiction. Self-management of risks focused on the potential effects of excessive use, smoking-related risks, and purchasing precautions. Although the reports of women and men were similar in many respects, there were important differences in patterns and practices of use that reflected gender influences. Insights from the study provide direction for developing gender-specific information to support decision making and usage for therapeutic users.