MulTI-domain self-management in older People wiTh OstEoarthritis and multi-morbidities: protocol for the TIPTOE randomised controlled trial
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SUBMITTER: Deere R
PROVIDER: S-EPMC11344358 | biostudies-literature | 2024 Jan
REPOSITORIES: biostudies-literature
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Project description:PurposeOver half of individuals diagnosed with cancer are aged over 70 years, and more than 75% of those with cancer report at least one other medical condition. Having multiple conditions alongside cancer in old age may lower functional status, greater likelihood of treatment complications and less favourable prognoses. This qualitative study explored how older people with long-term chronic conditions manage their health and meet their health-related goals after they have completed treatment for cancer.MethodsOne-to-one face-to-face qualitative interviews were conducted with 8 older people and 2 informal caregivers based in the UK. Older adults were eligible to participate if they were over 70 and had completed primary cancer treatment with curative intent and had at least one other chronic health condition. A semi-structured interview schedule developed a priori based on Shippee's cumulative complexity model was used. We aimed to explore experiences that could influence self-management, utilisation of healthcare services and health outcomes. A framework analysis was used to describe and interpret the data.ResultsFour overarching themes were identified in the analysis. These themes related to factors that influenced the everyday health-related workload and capacity of the participants. These factors included their health, resources, and opportunities, as well their motivation and sense of perceived control over their lives.ConclusionsFragmented healthcare systems and relationships with healthcare professionals also influenced the participants' self-management of their health. Our findings highlight the interaction between an individuals' needs, capacity, treatment burden, and the services and resources available to them. These findings support calls to promote person-centred care to better support older adults to manage their health.
| S-EPMC8831683 | biostudies-literature
Project description:BackgroundExercise is recommended for all people with osteoarthritis. However, these recommendations are based on randomised clinical trials including people with an average age between 60 and 70 years, and these findings cannot reliably be generalised to people aged 80 years or older. Rapid loss of muscle occurs after 70 years of age, and older people are more likely to also have other health conditions that contribute to difficulties with daily activities and impact on their response to exercise. To improve care for people aged 80 or older with osteoarthritis, it is thought that a tailored exercise intervention targeting both osteoarthritis and any other health conditions they have, may be needed. The aim of this study will be to test if it is possible to conduct a randomised controlled trial (RCT) for people over 80 years of age with hip/knee osteoarthritis of a tailored exercise intervention.MethodsA multicentre, parallel, 2-group, feasibility RCT with embedded qualitative study, conducted in ≥ 3 UK NHS physiotherapy outpatient services. Participants (n ≥ 50) with clinical knee and/or hip osteoarthritis and ≥ 1 comorbidity will be recruited by screening referrals to participating NHS physiotherapy outpatient services, via screening of general practice records and via identification of eligible individuals from a cohort study run by our research group. Participants will be randomised (computer-generated: 1:1) to receive either: a 12-week education and tailored exercise intervention (TEMPO); or usual care and written information. The primary feasibility objectives are to estimate: (1) ability to screen and recruit eligible participants; (2) retention of participants, measured by the proportion of participants who provide outcome data at 14-week follow-up. Secondary quantitative objectives are to estimate: (1) participant engagement assessed by physiotherapy session attendance and home exercise adherence; (2) sample size calculation for a definitive RCT. One-to-one semi-structured interviews will explore the experiences of trial participants and physiotherapists delivering the TEMPO programme.DiscussionProgression criteria will be used to determine whether a definitive trial to evaluate the clinical and cost-effectiveness of the TEMPO programme is considered feasible with or without modifications to the intervention or trial design.Trial registrationISRCTN75983430. Registered 3/12/2021. https://www.isrctn.com/ISRCTN75983430.
| S-EPMC10067159 | biostudies-literature
Project description:BackgroundOsteoarthritis (OA) is not curable, but the symptoms can be managed through self-management programs (SMPs). Owing to the growing burden of OA on the health system and the need to ensure high-quality integrated services, delivering SMPs through digital technologies could be an economic and effective community-based approach.ObjectiveThis study aims to analyze the effectiveness of digital-based structured SMPs on patient outcomes in people with OA.MethodsA total of 7 web-based and 3 gray literature databases were searched for randomized controlled trials assessing digital-based structured SMPs on self-reported outcomes including pain, physical function, disability, and health-related quality of life (QoL) in people with OA. Two reviewers independently screened the search results and reference lists of the identified papers and related reviews. Data on the intervention components and delivery and behavioral change techniques used were extracted. A meta-analysis, risk of bias sensitivity analysis, and subgroup analysis were performed where appropriate. The Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach was used to assess the quality of evidence.ResultsA total of 8 studies were included in this review involving 2687 patients with knee (n=2); knee, hip, or both (n=5); and unspecified joint (n=1) OA. SMPs were delivered via telephone plus audio and video, internet, or mobile apps. Studies reported that digital-based structured SMPs compared with the treatment as usual control group (n=7) resulted in a significant, homogeneous, medium reduction in pain and improvement in physical function (standardized mean difference [SMD] -0.28, 95% CI -0.38 to -0.18 and SMD -0.26, 95% CI -0.35 to -0.16, respectively) at posttreatment. The digital-based structured SMP effect on pain and function reduced slightly at the 12-month follow-up but remained to be medium and significant. The posttreatment effect of digital-based structured SMPs was small and significant for disability, but nonsignificant for QoL (SMD -0.10, 95% CI -0.17 to 0.03 and SMD -0.17, 95% CI -0.47 to 0.14, respectively; each reported in 1 study only). The 12-month follow-up effect of the intervention was very small for disability and QoL. The quality of evidence was rated as moderate for pain and physical function and low and very low for disability and QoL, respectively, using the GRADE approach.ConclusionsDigital-based structured SMPs may result in improvement in pain and physical function that is largely sustained at the 12-month follow-up in people with knee and hip OA. The effects on disability and QoL are smaller and less clear. The quality of evidence is moderate to low, and further research is required to confirm the findings of the review and assess the effects of digital-based structured SMPs on other health-related outcomes.
| S-EPMC7428148 | biostudies-literature
Project description:BackgroundOsteoarthritis is the leading cause of disability in older adults. Evidence of effectiveness for self-management of hand osteoarthritis is lacking.MethodsIn this randomised, factorial trial, we evaluated the effectiveness of joint protection versus no joint protection, and hand exercise versus no hand exercise in adults, 50 years of age or older, with hand osteoarthritis. Following a population survey (n=12 297), eligible individuals were randomly assigned (1:1:1:1) to: leaflet and advice; joint protection; hand exercise; joint protection plus hand exercise. Joint protection and hand exercises were delivered by nine occupational therapists, over four group sessions. The primary outcome was the OARSI/OMERACT responder criteria at 6 months. Outcomes were collected blind to allocation (3, 6, 12 m). Analysis was by intention to treat.ResultsOf 257 participants randomised (65:62:65:65) (mean age (SD) 66 years (9.1); female 66%) follow-up was 85% at 6 m (n=212). Baseline characteristics and loss to follow-up were similar between groups. There were no reported treatment side effects. At 6 m 33% assigned joint protection were responders compared with 21% with no joint protection (p=0.03). Of those assigned hand exercises, 28% were responders compared with 25% with no exercises (n.s.). Differences in secondary outcomes were not statistically significant, except for improvement in pain self-efficacy with joint protection (3 m p=0.002; 6 m p=0.001; 12 m p=0.03).ConclusionsThese findings show that occupational therapists can support self-management in older adults with hand osteoarthritis, and that joint protection provides an effective intervention for medium term outcome. (Funded by the Arthritis Research UK ISRCTN 33870549).
| S-EPMC4283664 | biostudies-literature
Project description:ObjectiveTo explore and describe older African Americans' patterns and perceptions of managing chronic osteoarthritis pain.MethodsA convergent parallel mixed-methods design incorporating cross-sectional surveys and individual, semistructured interviews.SettingOne hundred ten African Americans (≥50 years of age) with clinical osteoarthritis (OA) or provider-diagnosed OA from communities in northern Louisiana were enrolled.ResultsAlthough frequency varied depending on the severity of pain, older African Americans actively used an average of seven to eight self-management strategies over the course of a month to control pain. The average number of self-management strategies between high and low education and literacy groups was not statistically different, but higher-educated adults used approximately one additional strategy than those with high school or less. To achieve pain relief, African Americans relied on 10 self-management strategies that were inexpensive, easy to use and access, and generally perceived as helpful: over-the-counter (OTC) topicals, thermal modalities, land-based exercise, spiritual activities, OTC and prescribed analgesics, orthotic and assistive devices, joint injections, rest, and massage and vitamins.ConclusionsThis is one of the first studies to quantitatively and qualitatively investigate the self-management of chronic OA pain in an older African American population that happened to be a predominantly higher-educated and health-literate sample. Findings indicate that Southern-dwelling African Americans are highly engaged in a range of different self-management strategies, many of which are self-initiated. Although still an important component of chronic pain self-management, spirituality was used by less than half of African Americans, but use of oral nonsteroidal anti-inflammatory drugs and opioids was relatively high.
| S-EPMC7963201 | biostudies-literature
Project description:IntroductionFalls among people with multiple sclerosis (PwMS) are common and associated with injuries, fear of falling and low health-related quality of life. Considerations of behavioural, environmental, psychological and physical influences (including ambulation status) are needed to meet fall prevention needs for PwMS. Thus, using a codesign process involving key stakeholders a novel online self-management fall prevention intervention was created specifically for ambulatory and non-ambulatory PwMS. The feasibility, acceptability, fidelity and outcome of this complex intervention will be explored. Findings will inform a future full-scale randomised controlled trial.Methods and analysisA mixed-method design will be used. Forty-eight PwMS, stratified for ambulation level, will be randomised to control (n=24) or intervention (n=24). Both groups will receive a brochure about fall risk factors and fall prevention. The intervention is group-based (eight PwMS in each group); will be delivered online; and involve six, 2-hour weekly sessions and a booster session 8 weeks after the sixth session. Each intervention group will be led by a trained facilitator. Data collection will be performed at baseline, and after seven and 18 weeks. Outcome measures will capture data on fall prevention behaviours, fear of falling, falls self-efficacy, social and everyday activities, perceived impact of MS and number of falls. Feasibility of recruitment process, data collection procedures, outcome measures, and delivery, and intervention acceptability, fidelity and outcomes will be evaluated. Both quantitative and qualitative methods will be used.Ethics and disseminationEthical approval has been obtained from the Swedish Ethical Review Authority (registration number 2021-04817). Results will be disseminated in peer-review journals, at conferences, research meetings, in social media and through the patient organisation Neuro Sweden.Trial registration numberNCT04317716.
| S-EPMC9272100 | biostudies-literature
Project description:With ageing, older people can become frail, and this has been shown to be associated with a decrease in well-being. Observational studies provide evidence of a positive effect of coping resources on well-being. The question is: can coping resources be improved in vulnerable older people? The Chronic Disease Self-Management Program (CDSMP) is a target group-specific intervention which aims to promote the self-management of older people who are confronted with deteriorating health. The aim of this study was to review intervention studies focusing on the CDSMP and to draw conclusions on the benefits of the program. A systematic search was conducted in PubMed and PsychINFO to identify randomized controlled trials (RCTs) focusing on the CDSMP. Nine RCTs focusing on relatively young older adults, 75% of whom with an average age between 49 and 65 years, were included. We found that the CDSMP was consistently beneficial for Health behaviour, especially with regard to the variables of exercise and self-care. For Health status, the majority of studies only showed improvement in the domain of health distress. Most of the studies that investigated Self-efficacy showed convincing improvement in self-efficacy, cognitive symptom management and mental stress management. In Health care utilization, there was no significant decrease. On the whole, the studies showed that CDSMP led to an increase in physical exercise, a decrease in health distress, an improvement in self-care, and it had a beneficial effect on self-efficacy.
| S-EPMC2776941 | biostudies-other
Project description:ObjectiveTo determine the feasibility of conducting a randomised controlled trial (RCT) of a peer mentorship intervention to improve self-management of osteoarthritis (OA).DesignSix-month parallel group non-blinded randomised feasibility trial.SettingOne secondary care and one primary care UK National Health Service Trust.ParticipantsFifty adults aged ≥55 years old with hip and/or knee OA.InterventionsParticipants were allocated 1:1 to the intervention or control group using an online randomisation service. Intervention group participants received usual care (information resources) and up to eight community-based self-management support sessions delivered by a peer mentor (trained volunteer with hip and/or knee OA). Control group participants received usual care only.Outcome measuresKey feasibility outcomes were participant and peer mentor recruitment and attrition, intervention completion and the sample size required for a definitive RCT. Based on these feasibility outcomes, four success criteria for proceeding to a definitive RCT were prespecified. Patient-reported outcomes were collected via questionnaires at baseline, 8 weeks and 6 months.ResultsNinety-six individuals were screened, 65 were eligible and 50 were randomised (25 per group). Of the 24 participants who commenced the intervention, 20 completed it. Four participants did not complete the 6-month questionnaire. Twenty-one individuals were eligible for the peer mentor role, 15 were trained and 5 withdrew prior to being matched with a participant. No intervention-related harms occurred. Allowing for 20% attrition, the sample size required for a definitive RCT was calculated as 170 participants. The intervention group showed improvements in self-management compared with the control group.ConclusionsThe feasibility outcomes achieved the prespecified criteria for proceeding to an RCT. The exploratory analyses suggest peer mentorship may improve OA self-management. An RCT of the OA peer mentorship intervention is therefore warranted with minor modifications to the intervention and trial procedures.Trial registration numberISRCTN:50675542.
| S-EPMC8296761 | biostudies-literature
Project description:BackgroundPatient education, hand exercises, and the use of assistive devices are recommended as first-line treatments for individuals with hand osteoarthritis (OA). However, the quality of care services for this patient group is suboptimal in primary care.ObjectiveThe overarching goal was to develop and evaluate feasibility of an app-based self-management intervention for people with hand OA. This feasibility study aims to assess self-reported usability and satisfaction, change in outcomes and quality-of-care, exercise adherence and patients' experiences using the app.MethodsThe development and feasibility testing followed the first 2 phases of the Medical Research Council framework for the development and evaluation of complex interventions and were conducted in close collaboration with patient research partners (PRPs). A 3-month pre-post mixed methods design was used to evaluate feasibility. Men and women over 40 years of age diagnosed with painful, symptomatic hand OA were recruited. Usability was assessed using the System Usability Scale (0-100), while satisfaction, usefulness, pain, and stiffness were evaluated using a numeric rating scale (NRS score from 0 to 10). The activity performance of the hand was measured using the Measure of Activity Performance of the Hand (MAP-Hand) (1-4), grip strength was assessed with a Jamar dynamometer (kg), and self-reported quality of care was evaluated using the Osteoarthritis Quality Indicator questionnaire (0-100). Participants were deemed adherent if they completed at least 2 exercise sessions per week for a minimum of 8 weeks. Focus groups were conducted to explore participants' experiences using the app. Changes were analyzed using a paired sample t test (mean change and 95% CI), with the significance level set at P<.05.ResultsThe first version of the Happy Hands app was developed based on the needs and requirements of the PRPs, evidence-based treatment recommendations, and the experiences of individuals living with hand OA. The app was designed to guide participants through a series of informational videos, exercise videos, questionnaires, quizzes, and customized feedback over a 3-month period. The feasibility study included 71 participants (mean age 64 years, SD 8; n=61, 86%, women), of whom 57 (80%) completed the assessment after 3 months. Usability (mean 91.5 points, SD 9.2 points), usefulness (median 8, IQR 7-10), and satisfaction (median 8, IQR 7-10) were high. Significant improvements were observed in self-reported quality of care (36.4 points, 95% CI 29.7-43.1, P<.001), grip strength (right: 2.9 kg, 95% CI 1.7-4.1; left: 3.2 kg, 95% CI 1.9-4.6, P<.001), activity performance (0.18 points, 95% CI 0.11-0.25, P<.001), pain (1.7 points, 95% CI 1.2-2.2, P<.001), and stiffness (1.9 points, 95% CI 1.3-2.4, P=.001) after 3 months. Of the 71 participants, 53 (75%) were adherent to the exercise program. The focus groups supported these results and led to the implementation of several enhancements in the second version of the app.ConclusionsThe app-based self-management intervention was deemed highly usable and useful by patients. The results further indicated that the intervention may improve quality of care, grip strength, activity performance, pain, and stiffness. However, definitive conclusions need to be confirmed in a powered randomized controlled trial.Trial registrationNCT05150171.
| S-EPMC11558211 | biostudies-literature
Project description:BackgroundClinical practice guidelines recommend exercise as the first line of management for hip osteoarthritis, yet high-quality evidence from Cochrane reviews suggest only slight benefits for pain and physical function; and no benefit on quality of life (low-quality evidence). However, the scope of physical impairments identified in people with hip osteoarthritis may not have been adequately addressed with targeted rehabilitation options in previous randomised controlled trials (RCTs). Potential targeted options include gait retraining to address spatio-temporal impairments in walking; motor control training to address deep gluteal (gluteus minimus) dysfunction; and progressive, high-intensity resistance exercises to address atrophy of the gluteal muscles. The aim of this study is to investigate the effect of a targeted gluteal rehabilitation programme that incorporates gait retraining, motor control and progressive, high-intensity resistance-strength training, to address physical activity levels and self-reported physical function in people with mild to moderate disability from hip osteoarthritis.MethodsNinety people diagnosed with mild to moderately disabling hip osteoarthritis will be recruited and randomised to receive one of two exercise programmes (sham or GHOst programme). Interventions will be 12 weeks in duration, with weekly, supervised physiotherapy sessions, and daily home exercises. Both groups will receive standardised education. Outcomes will be assessed at baseline, 7 weeks, 13 weeks (primary time-point) and 25 weeks. The primary outcome will be self-reported physical function measured with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Secondary outcomes include physical activity measured with a tri-axial accelerometer, physical function tests, self-reported physical activity, isometric hip-muscle strength tests, hip-related patient-reported outcome measures, pain thoughts and depressive symptoms, quality of life, global rating of change, gluteal-muscle activity (electromyography (EMG)) and gluteal-muscle size and adiposity (magnetic resonance imaging (MRI)).DiscussionThis will be the first study to compare a targeted gluteal rehabilitation programme to a sham exercise programme. The targeted GHOst programme includes exercises designed to address gait impairments as well as gluteal-muscle atrophy and dysfunction.Trial registrationAustralian New Zealand Clinical Trials Registry, ID: ACTRN12617000970347 . Registered retrospectively on 5 July 2017. Protocol version 3.0.
| S-EPMC6149073 | biostudies-literature