mHealth intervention including text messaging and behaviour change techniques to support maintenance of physical activity after cardiac rehabilitation: A single-arm feasibility study.

Objective: To evaluate the feasibility of a mobile health-supported intervention in patients with cardiovascular diseases after completion of a cardiac rehabilitation programme. Methods: The feasibility study was performed in two hospitals and one municipality in Region Zealand, Denmark. Eligible participants were ≥18 years old, participated in a supervised cardiac rehabilitation programme, had access to a mobile phone, and could walk 3 m independently. Participants received a 12-week intervention utilizing behaviour change techniques, consisting of action planning, text messages, and phone support. Feasibility was assessed using pre-defined progression criteria, which included recruitment (≥75%), retention (≥80%), accelerometer data completeness (≥80%), coordinator (phone support) time (≤30 min), the response rate on patient-reported outcomes (≥90%), adherence (≥75% respond to ≥75% of messages), and acceptability (≥75%). The secondary outcome of objective physical activity was assessed with accelerometers. Results: Ten women and 30 men with cardiovascular diseases aged 63.5 (±9.8 SD) participated. The progression criteria for retention (90%), accelerometer data completeness (83%), coordinator time (9.9 min), adherence (83%), and acceptability (82%) were at acceptable levels, exceptions were progression criteria for recruitment (35%) being below acceptable levels for recruitment, and response rate on patient-reported outcomes (75%). High satisfaction (92.6%) with the intervention was found. All objectively measured physical activity levels remained unchanged from baseline to follow-up. No serious adverse events related to the intervention were reported. Conclusion: Mobile health-supported maintenance of physical activity after cardiac rehabilitation completion was feasible, safe, and acceptable. Yet, changes to improve recruitment and response rate are needed before conducting a large-scale effect evaluation.

Mapping interventional components and behavior change techniques used to promote self-management in people with multimorbidity: a scoping review.

Ageing populations and improved survival, have contributed to a rise in the number of people living with multimorbidity, raising issues related to polypharmacy, treatment burden, competing priorities and poor coordination of care. Self-management programs are increasingly included as an essential component of interventions to improve outcomes in this population. However, an overview of how interventions supporting self-management in patients with multimorbidity is missing. This scoping review focused on mapping the literature on patient-centered interventions for people living with multimorbidity. We searched several databases, clinical registries, and grey literature for RCTs published between 1990-2019 describing interventions that supported self-management in people with multimorbidity. We included 72 studies that were found to be very heterogeneous when it comes to the population, delivery modes and modalities, intervention elements and facilitators. The results pointed to an extensive use of cognitive behavioral therapy as a basis for interventions, as well as behavior change theories and disease management frameworks. The most coded behavior change techniques stemmed from the categories Social Support, Feedback and monitoring and Goals and Planning. To allow for implementation of effective interventions in clinical practice, improved reporting of intervention mechanisms in RCTs is warranted.

Experience and usability of a website containing research-based knowledge and tools for pain self-management: a mixed-method study in people with high-impact chronic pain.

OBJECTIVES: Smerteinfo.dk is a freely accessible Danish website containing research-based, up-to-date knowledge on chronic pain, written in lay language, with a focus on information, guidance and self-management tools, developed in collaboration between health professionals and persons with high-impact chronic pain. This mixed-method study explored experiences, perceived usability, and challenges of Smerteinfo among patients with high-impact chronic pain. METHODS: Semi-structured interviews enabling thinking-aloud and participant observation while using Smerteinfo were performed in 11 patients with high-impact chronic pain. Survey data were collected three months after being invited to use Smerteinfo among 200 patients on waiting-list at a Pain Center in Denmark. RESULTS: Three themes captured the depth and variation in patterns of experiences, usability and challenges using Smerteinfo during interviews: 1) Appreciated easy access to new knowledge yet strived for more personalized information, 2) Experienced incentives as well as challenges when navigating the website, and 3) Suggested earlier introduction to the website. Challenges concerned the unknown update frequency of the website, information consisting of mostly text and many links, lack of material to improve self-management and too general information. Survey data revealed that 87 % found the language in the articles easy to understand and 73 % could recognize themselves and their challenges in the articles. A proportion of the respondents reported improved understanding of their pain condition (56 %), improved coping (33 %), and that they had made changes in their everyday life after reading on the website (33 %). CONCLUSIONS: Patients with high-impact chronic pain found Smerteinfo valuable. The results suggest attention towards spreading knowledge of the website to general practitioners, who could introduce the site at an earlier stage of illness. Continuously improving the site and expand the applicable tools based on scientific evidence and in collaboration with end-users are crucial to ensure the usability of the website in the future.

Study protocol for a multicenter randomized controlled trial of personalized exercise therapy and self-management support for people with multimorbidity: The MOBILIZE study.

Background: Despite the great individual and societal burden associated with multimorbidity, little is known about how to effectively manage it. Objective: The aim of this multicenter randomized controlled trial (RCT) is to investigate the 12-month effects of a personalized exercise therapy and self-management support program in addition to usual care in people with multimorbidity. Design: This is a protocol for a pragmatic, parallel-group (1:1 ratio), superiority RCT conducted at five intervention sites (two hospitals, a private practice physiotherapy clinic and two municipal rehabilitation centers) in Region Zealand, Denmark. A total of 228 persons with multimorbidity aged 18 years or older, will be randomly allocated to one of two groups. Both groups will receive usual care, defined as routine care for multimorbidity at the discretion of the treating doctor, while the intervention group will also participate in a 12-week exercise therapy and self-management support program tailored to people with multimorbidity at one of the intervention sites. The primary outcome will be the between-group difference in change in EQ-5D-5L from baseline to the follow-up at 12 months. Secondary outcomes include objectively-measured physical function and physical activity, inflammatory markers, disease and treatment burden, anxiety, depression, stress, sleep, pain and other self-reported parameters. In parallel with the RCT, an observational cohort will follow persons aged ≥18 years with multimorbidity not adhering to all eligibility criteria, as well as people fulfilling all eligibility criteria, but unwilling to participate in the RCT. This study was approved by the Regional Committee on Health Research Ethics for Region Zealand (SJ-857) and results will be communicated in scientific papers, at relevant conferences and to a broader audience. Discussion: Exercise therapy and self-management support is safe and effective in people with single conditions. However, it is still unclear whether this holds true for individuals with multimorbidity. This pragmatic, multicenter RCT will provide high-quality evidence on the benefits and harms of exercise therapy and self-management support and, if the results support it, lead to the development of a plan for implementation in clinical practice.

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/.

Effect of In-Person Delivered Behavioural Interventions in People with Multimorbidity: Systematic Review and Meta-analysis.

BACKGROUND: To investigate the effect of in-person delivered behavioural interventions in people with multimorbidity and which behaviour change techniques (BCTs), targeting lifestyle behaviours, are associated with better outcomes. METHODS: Systematic review of randomised controlled trials. We searched MEDLINE, EMBASE, CENTRAL, and CINAHL and screened reference list of reviews including people with multimorbidity, registries, and citation tracking of included studies. Meta-analyses using random-effects model to assess the effect of behavioural interventions and meta-regression analyses and effectiveness ratios to investigate the impact of mediators on effect estimates. Cochrane 'Risk of Bias Tool' 2.0 and the GRADE assessment to evaluate the overall quality of evidence. RESULTS: Fourteen studies involving 1,378 people. Behavioural interventions had little to no effect on physical activity (standardised mean difference 0.38, 95% CI -0.12-0.87) and the effect on weight loss was uncertain (BMI mean difference -0.17, 95% CI -1.1-0.83) at the end-treatment follow-up. Small improvements were seen in health-related quality of life (SMD 0.29, 95% CI 0.17-0.42) and physical function (SMD 0.42, 95% CI 0.12-0.73), and moderate improvements were seen for depression symptoms (SMD -0.70, 95% CI -0.97-0.42). Studies using the BCTs 'action planning' and 'social support (practical)' reported greater physical activity and weight loss. CONCLUSIONS: Behavioural interventions targeting lifestyle behaviours may improve health-related quality of life and physical function, and reduce depression, whereas little to no effect was achieved on physical activity and weight loss in people with multimorbidity. However, the evidence for physical activity and weight loss were of low quality and the end-treatment benefits diminished over time.

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

BACKGROUND: To our knowledge, there is no intervention which includes personalised exercise therapy and self-management support for people with multimorbidity, although these interventions may be as effective as for people with single chronic conditions. Therefore, we developed a novel intervention, including personalised exercise therapy and self-management support for people with multimorbidity. METHODS: We followed the Medical Research Council framework and conducted one scoping review, five systematic reviews, two registry-based studies, one qualitative interview study and a mixed-methods feasibility study. Following an iterative approach, together with feedback from people with multimorbidity and relevant stakeholders, we developed the MOBILIZE intervention. RESULTS: The intervention included 24 (60 minutes) sessions of personalised exercise therapy and 24 (30 minutes) sessions of self-management support twice a week for 12 weeks, delivered in small groups by specifically trained physiotherapists. The intervention targets physiological, psychosocial, behavioural, and contextual factors to improve health-related quality of life and physical function in people living with multimorbidity. CONCLUSIONS: We developed a personalised exercise therapy and self-management support programme for people with multimorbidity. The intervention will be tested for its safety and effectiveness in a randomised controlled trial.

Putting the pieces together: A qualitative study exploring perspectives on self-management and exercise behavior among people living with multimorbidity, healthcare professionals, relatives, and patient advocates.

Background Behavior change and exercise are considered critical for successful self-management in people with multimorbidity, however, little is known about people's needs, experiences, and preferences. Purpose The aim of this study was to qualitatively explore the perspectives of people living with multimorbidity, healthcare professionals, relatives, and patient advocates in relation to self-management and exercise behavior. Research design Analysis was carried out by means of a hybrid inductive-deductive approach using Framework Analysis that enabled the subsequent use of the COM-B model in relation to the study of exercise behavior specifically. Study sample We conducted 17 interviews (9 focus groups; 8 key informants) with 48 informants from four groups (22 people living with multimorbidity, 17 healthcare professionals, 5 relatives, and 5 patient advocates). Data analysis Through an inductive Framework analysis, we constructed three themes: Patient education, supporting behavior change, and lack of a "burning platform." Subsequent deductive application of the COM-B profile (applied solely to data related to exercise behavior) unveiled a variety of barriers to exercise and self-management support (pain, fatigue, breathlessness, lack of motivation, financial issues, accessibility, decreased social support). Results Overall, the four groups shared common understandings while also expressing unique challenges. Conclusions Future interventions and/or policies targeting exercise behavior in people living with multimorbidity should address some of the barriers identified in this study.

Maintenance of physical activity after cardiac rehabilitation (FAIR): study protocol for a feasibility trial.

INTRODUCTION: To enhance health and prevent secondary consequences for patients with cardiovascular disease (CVD), maintenance of an active lifestyle following participation in cardiac rehabilitation (CR) is important. However, levels of physical activity often decrease after completion of a structured CR programme. Models that support long-term behaviour change with a sustained level of physical activity are imperative. The aim of this study is to evaluate the feasibility of a mobile health intervention based on the Health Action Process Approach theoretical model of behaviour change in patients with CVD for 3 months after completion of a CR programme. METHODS AND ANALYSIS: In a feasibility trial design, we will recruit 40 participants from CR programmes at Slagelse Hospital, the City of Slagelse (municipality), or Holbæk Hospital. After completing the standard structured CR programme, each participant will create an action plan for physical activity together with a physiotherapist. Following that, participants are sent 2 weekly text messages for 3 months. The first text message prompts physical activity, and the second will check if the action plan has been followed. If requested by participants, a coordinator will call and guide the physical activities behaviour. The feasibility of this maintenance intervention is evaluated based on predefined progression criteria. Physical activity is measured with accelerometers at baseline and at 3 months follow-up. ETHICS AND DISSEMINATION: Study approval was waived (EMN-2021-00020) by the Research Ethics Committee of Region Zealand, Denmark. Study results will be made public and findings disseminated to patients, health professionals, decision-makers, researchers and the public. TRIAL REGISTRATION NUMBER: NCT05011994.

The Quality of Health Apps and Their Potential to Promote Behavior Change in Patients With a Chronic Condition or Multimorbidity: Systematic Search in App Store and Google Play.

BACKGROUND: Mobile apps offer an opportunity to improve the lifestyle of patients with chronic conditions or multimorbidity. However, for apps to be recommended in clinical practice, their quality and potential for promoting behavior change must be considered. OBJECTIVE: We aimed to investigate the quality of health apps for patients with a chronic condition or multimorbidity (defined as 2 or more chronic conditions) and their potential for promoting behavior change. METHODS: We followed the Cochrane Handbook guidelines to conduct and report this study. A systematic search of apps available in English or Danish on App Store (Apple Inc) and Google Play (Google LLC) for patients with 1 or more of the following common and disabling conditions was conducted: osteoarthritis, heart conditions (heart failure and ischemic heart disease), hypertension, type 2 diabetes mellitus, depression, and chronic obstructive pulmonary disease. For the search strategy, keywords related to these conditions were combined. One author screened the titles and content of the identified apps. Subsequently, 3 authors independently downloaded the apps onto a smartphone and assessed the quality of the apps and their potential for promoting behavior change by using the Mobile App Rating Scale (MARS; number of items: 23; score: range 0-5 [higher is better]) and the App Behavior Change Scale (ABACUS; number of items: 21; score: range 0-21 [higher is better]), respectively. We included the five highest-rated apps and the five most downloaded apps but only assessed free content for their quality and potential for promoting behavior change. RESULTS: We screened 453 apps and ultimately included 60. Of the 60 apps, 35 (58%) were available in both App Store and Google Play. The overall average quality score of the apps was 3.48 (SD 0.28) on the MARS, and their overall average score for their potential to promote behavior change was 8.07 (SD 2.30) on the ABACUS. Apps for depression and apps for patients with multimorbidity tended to have higher overall MARS and ABACUS scores, respectively. The most common app features for supporting behavior change were the self-monitoring of physiological parameters (eg, blood pressure monitoring; apps: 38/60, 63%), weight and diet (apps: 25/60, 42%), or physical activity (apps: 22/60, 37%) and stress management (apps: 22/60, 37%). Only 8 out of the 60 apps (13%) were completely free. CONCLUSIONS: Apps for patients with a chronic condition or multimorbidity appear to be of acceptable quality but have low to moderate potential for promoting behavior change. Our results provide a useful overview for patients and clinicians who would like to use apps for managing chronic conditions and indicate the need to improve health apps in terms of their quality and potential for promoting behavior change.

Recruitment and retention rates in randomised controlled trials of exercise therapy in people with multimorbidity: a systematic review and meta-analysis.

AIM: To quantify recruitment, retention and differential retention rates and associated trial, participant and intervention characteristics in randomised controlled trials (RCTs) evaluating the effect of exercise therapy in people with multimorbidity. DATA SOURCES: MEDLINE, EMBASE, CINAHL and CENTRAL from 1990 to April 20, 2020. STUDY SELECTION: RCTs including people with multimorbidity comparing exercise therapy with a non-exposed comparator group reporting at least one of the following outcomes: physical function, health-related quality of life, depression symptoms, or anxiety symptoms. DATA EXTRACTION AND SYNTHESIS: Recruitment rates (proportion of people randomised/proportion of people eligible), retention rates (proportion of people providing the outcomes of interest/proportion randomised) and differential retention rates (difference in proportion of people providing the outcomes in the intervention group and comparator group) were calculated. Meta-analysis using a random-effects model was used to estimate pooled proportions. Methodological quality was assessed using Cochrane ´Risk of Bias tool 2.0´ for individual studies, and the GRADE approach was used to assess the overall quality of the evidence. RESULTS: Twenty-three RCTs with 3363 people were included. The pooled prevalence for recruitment rate was 75% (95%CI 66 to 84%). The pooled prevalence for retention rate was 90% (95%CI 86 to 94%) at the end of the intervention (12 weeks; interquartile range (IQR) (12 to 12)). Meta-regression analyses showed that increasing age and including a higher proportion of people with hypertension was associated with lower retention rates. Retention rates did not differ between the intervention and comparator groups. The overall quality of the evidence was deemed very low. CONCLUSION: Three in four eligible people with multimorbidity were randomised to RCTs using exercise therapy, of which nine out of 10 provided end of treatment outcomes with no difference seen between the intervention and comparison groups. However, the results must be interpreted with caution due to large differences between the included studies. TRIAL REGISTRATION: ClinicalTrials.gov CRD42020161329 . Registered on 28 April 2020.

Benefits and harms of exercise therapy in people with multimorbidity: A systematic review and meta-analysis of randomised controlled trials.

OBJECTIVES: To investigate the benefits and harms of exercise therapy on physical and psychosocial health in people with multimorbidity. DESIGN: Systematic review of randomised controlled trials (RCTs). Data sources MEDLINE, EMBASE, CENTRAL and CINAHL from 1990 to April 20th, 2020 and Cochrane reviews on the effect of exercise therapy for each of the aforementioned conditions, reference lists of the included studies, the WHO registry and citation tracking on included studies in Web of Science. ELIGIBILITY CRITERIA FOR STUDY SELECTION: RCTs investigating the benefit of exercise therapy in people with multimorbidity, defined as two or more of the following conditions: osteoarthritis (of the knee or hip), hypertension, type 2 diabetes, depression, heart failure, ischemic heart disease, and chronic obstructive pulmonary disease on at least one of the following outcomes: Health-related quality of life (HRQoL), physical function, depression or anxiety. SUMMARY AND QUALITY OF THE EVIDENCE: Meta-analyses using a random-effects model to assess the benefit of exercise therapy and the risk of non-serious and serious adverse events according to the Food and Drug Administration definition. Meta-regression analyses to investigate the impact of pre-specified mediators of effect estimates. Cochrane 'Risk of Bias Tool' 2.0 and the GRADE assessment to evaluate the overall quality of evidence. RESULTS: Twenty-three RCTs with 3363 people, testing an exercise therapy intervention (mean duration 13.0 weeks, SD 4.0) showed that exercise therapy improved HRQoL (standardised mean difference (SMD) 0.37, 95 % CI 0.14 to 0.61) and objectively measured physical function (SMD 0.33, 95 % CI 0.17 to 0.49), and reduced depression symptoms (SMD -0.80, 95 % CI -1.21 to -0.40) and anxiety symptoms (SMD -0.49, 95 % CI -0.99 to 0.01). Exercise therapy was not associated with an increased risk of non-serious adverse events (risk ratio 0.96, 95 % CI 0.53-1.76). By contrast, exercise therapy was associated with a reduced risk of serious adverse events (risk ratio 0.62, 95 % CI 0.49 to 0.78). Meta-regression showed that increasing age was associated with lower effect sizes for HRQoL and greater baseline depression severity was associated with greater reduction of depression symptoms. The overall quality of evidence for all the outcomes was downgraded to low, mainly due to risk of bias, inconsistency and indirectness. CONCLUSIONS: Exercise therapy appears to be safe and to have a beneficial effect on physical and psychosocial health in people with multimorbidity. Although the evidence supporting this was of low quality, it highlights the potential of exercise therapy in the management and care of this population.