Personalised exercise therapy and self-management support for people with multimorbidity: feasibility of the MOBILIZE intervention.

BACKGROUND: Exercise therapy is safe and effective in people with single conditions, but the feasibility in people with two or more conditions is unclear. Therefore, the aim was to evaluate the feasibility of exercise therapy and self-management in people with multimorbidity prior to a randomised, controlled trial (RCT). METHODS: This was a mixed-methods feasibility study performed in two general hospitals and one psychiatric hospital. 20 adult patients (8 females; mean age (SD) 67 (6.9)) with at least two long-term conditions and a score of ≥ 3 on Disease Burden Impact Scale for at least one condition (at least moderate limitations of daily activities) and of ≥ 2 for at least one other condition. Patients with unstable health conditions, at risk of serious adverse events (SAE) or with terminal conditions were excluded. Participants received 12 weeks of exercise (18 60-min group-based and 6 home-based sessions) and self-management support (6 90-min group-based sessions) supervised by physiotherapists. Pre-defined progression to RCT criteria were the primary outcomes and included recruitment rate (acceptable 20 participants in 3 months), retention through follow-up (75% retention), compliance (75% complete > 9 of exercise and > 3 self-management sessions), outcome burden (80% do not find outcomes too burdensome), improvement in quality of life (EQ-5D-5L) and function (6-min walk test; ≥ 50% experience clinically relevant improvements) and intervention-related SAEs (No SAEs). Furthermore, a purposeful sample including eleven participants and two facilitators were interviewed about their experiences of participating/facilitating. Qualitative data was analysed using thematic analysis. RESULTS: Recruitment rate (20 in 49 days), retention (85%), outcome burden (95%), and SAEs (0 related to intervention) were acceptable, while compliance (70%) and improvements (35% in quality of life, 46% in function) were not (amendment needed before proceeding to RCT). The intervention was found acceptable by both participants and physiotherapists with some barriers among participants relating to managing multiple chronic conditions while caring for others or maintaining a job. Physiotherapists expressed a need for additional training. CONCLUSIONS: Exercise therapy and self-management are feasible in people with multimorbidity. The subsequent RCT, amending the intervention according to progression criteria and feedback, will determine whether the intervention is superior to usual care alone. TRIAL REGISTRATION: ClinicalTrials.gov registration: NCT04645732 Open Science Framework https://osf.io/qk6yg/.

Feasibility and implementation fidelity of a co-designed intervention to promote in-hospital mobility among older medical patients-the WALK-Copenhagen project (WALK-Cph).

BACKGROUND: Mobility interventions can prevent functional decline among older patients, but implementation of such interventions may be complicated by barriers in the clinical setting. The WALK-Copenhagen project (WALK-Cph) is aimed at promoting a 24-h mobility among older medical patients during hospitalization. The WALK-Cph intervention was co-designed by researchers and stakeholders to tailor the intervention to the clinical context. The aim of this study was to investigate the feasibility and implementation fidelity of the WALK-Cph intervention before evaluating clinical effectiveness in a randomized controlled trial (ClinicalTrials.gov NCT03825497). METHODS: The WALK-Cph intervention consisted of six components: a welcome folder explaining the importance of in-hospital activity, a WALK-plan prescribing up to three daily walking sessions during and after hospitalization, a WALK-path in the hallway that patients were motivated to use daily, exercise posters in the hallways and bedrooms, self-service on beverages and clothes, and discharge with a WALK-plan. The present study reports on phase 2 of WALK-Cph and consists of a feasibility and a fidelity component. The study was conducted at the two WALK-Cph intervention departments after the initiation of the WALK-Cph intervention. A cohort of older medical patients (+65) was recruited for the feasibility study to assess recruitment and data collection procedures and the method for assessment of activity. Simultaneously, implementation fidelity was assessed by observing clinical practice and intervention delivery at the intervention departments. RESULTS: A feasibility cohort of 48 patients was included. Inclusion was considered feasible with recruitment rates between 62% and 70% of all eligible patients. Also, data collection was conducted without obstacles, and all patients accepted to wear activity monitors. The fidelity observations showed that three of the six intervention components were partially implemented as planned whereas three components were not implemented as planned. CONCLUSION: The WALK-Cph intervention was found feasible, and although the intervention was not implemented with fidelity, the level of fidelity was considered sufficient to continue with further testing of the WALK-Cph intervention in a large-scale trial. TRIAL REGISTRATION: ClinicalTrials.gov NCT03825497 (retrospectively registered). Protocol PubMed ID (PMID): 29523569.

Adaptations and modifications to a co-designed intervention and its clinical implementation: a qualitative study in Denmark.

BACKGROUND: There is a long-standing debate in implementation research on whether adaptations to evidence-based interventions (EBIs) are desirable in health care. If an intervention is adapted and not delivered as conceived and planned, it is said to have low fidelity. The WALK-Cph project was developed based on the assumption that involving stakeholders in co-design processes would facilitate the fidelity of an intervention to increase the mobility of acutely admitted older medical patients and its implementation in two hospitals in Denmark. The purpose of this study is to describe and analyse adaptations and modifications that were made to the co-designed WALK-Cph intervention and its implementation. METHODS: This study used a qualitative design. An ethnographic field study was performed using participant observations, workshops and semi-structured interviews. Data were analysed twice using the Framework Method. The first analysis was based on the frameworks from Stirman, Moore and Proctor. The second analysis, a retrospective modifications analysis, was based on the Adaptation-Impact Framework. RESULTS: Many different types of adaptations and modifications were made to the WALK-Cph intervention and its implementation plan. Most of the modifications were made on the contents of the intervention. In total, 44 adaptations and modifications were made, of which 21 were planned (adaptations) and 23 were made haphazardly (modifications). Most of the content and context adaptations and modifications made on the intervention had a mixed result regarding enhanced fidelity. The retrospective modifications analysis showed that modifications were ongoing and both situationally and contextually shaped. CONCLUSIONS: Although an extensive co-design process was carried out to facilitate the fidelity of the WALK-Cph intervention, this study showed that many adaptations and modifications were still made to both the intervention and its implementation plan. It could indicate that the co-design process had a small effect or that adaptations and modifications are ongoing and both situationally and contextually shaped, which challenge the assumption and the desire to be able to plan and control changes.

Is Promotion of Mobility in Older Patients Hospitalized for Medical Illness a Physician's Job?-An Interview Study with Physicians in Denmark.

: The aim of this study was to identify the most common barriers and facilitators physicians perceive regarding their role in the promotion of mobility in older adults hospitalized for medical illness as part of on an intervention to promote mobility. Twelve physicians at two medical departments were interviewed face-to-face using semi-structed interviews based on the Theoretical Domains Framework. The physicians' perceived barriers to promoting mobility were: the patients being too ill, the department's interior does not fit with mobility, a culture of bedrest, mobility not being part their job, lack of time and resources and unwillingness to accept an extra workload. The facilitators for encouraging mobility were enhanced cross-professional cooperation focusing on mobility, physician encouragement of mobility and patient independence in e.g., picking up beverages and clothes. The identified barriers and facilitators reflected both individual and social influences on physicians' behaviors to achieve increased mobility in hospitalized older medical patients and suggest that targeting multiple levels is necessary to influence physicians' propensity to promote mobility.