Evaluation of a Web-Based Self-Management Program for Patients With Cardiovascular Disease: Explorative Randomized Controlled Trial.

BACKGROUND: Web-based self-management programs have the potential to support patients with cardiovascular disease (CVD) in their self-management (eg, by focusing on behavior change and improving physical activity). The intervention mapping framework was used to develop a web-based program called Vascular View. The Vascular View program contained 6 modules (coping with CVD, setting boundaries, lifestyle, healthy nutrition, being physically active, interaction with health professionals) aiming to increase self-management behavior by tailoring to the perceived problems and (support) needs of patients after CVD. OBJECTIVE: The aim was to test the effectiveness of Vascular View before embarking on a full-scale randomized clinical trial (RCT) by evaluating the potential effectiveness and effect sizes of the Vascular View program and identifying outcome measures most likely to capture the potential benefits. METHODS: An explorative RCT was performed. Both control and intervention groups received care as usual and, in addition, the intervention group received 12 months of access to a web-based self-management program. Assessment occurred at baseline, 6 months, and 12 months. Outcome measures included general patient-reported outcome measurements: Illness Perception Questionnaire (IPQ), Rand-36, Patient Activation Measure, and patient self-efficacy. Module-specific patient-reported outcome measurements were Beliefs about Medicines Questionnaire, International Physical Activity Questionnaire, Dutch Healthy Diet Index, Fagerström Test for Nicotine Dependence (FTND), Alcohol Use Disorders Identification Test, and Perceived Efficacy in Patient-Physician Interaction. Linear mixed models for repeated measures using intention-to-treat and per-protocol analysis were applied to study differences between the patients in the intervention and control groups. Floor and ceiling effects were explored to give insight into the outcome measures most likely to capture the potential benefits. RESULTS: A total of 105 patients in the control group and 103 patients in the intervention group participated in the study. A positive direction of change between baseline and 12 months was shown for most outcome measurements in favor of the intervention group, of which 2 out of 10 outcomes showed a significant effect: attribution of cause of the disease to risk factors and immunity factors (IPQ) and dependency of nicotine (FTND). Floor and ceiling effects were seen in the IPQ, Rand-36, and the self-efficacy questionnaire. CONCLUSIONS: No conclusion for the efficacy of the Vascular View program or selection of outcome measurements can be taken yet. A process evaluation will be conducted to gain thorough insight into the working elements of the program, patient needs in eHealth, and the use of the program by patients. This can determine for whom web-based self-management programs will work and help to adapt the program. TRIAL REGISTRATION: Dutch Trial Register NTR5412; https://www.trialregister.nl/trial/5303. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/resprot.6352.

The diagnostic accuracy of headache measurement instruments: A systematic review and meta-analysis focusing on headaches associated with musculoskeletal symptoms.

AIM: To systematically review the available literature on the diagnostic accuracy of questionnaires and measurement instruments for headaches associated with musculoskeletal symptoms. DESIGN: Articles were eligible for inclusion when the diagnostic accuracy (sensitivity/specificity) was established for measurement instruments for headaches associated with musculoskeletal symptoms in an adult population. The databases searched were PubMed (1966-2018), Cochrane (1898-2018) and Cinahl (1988-2018). Methodological quality was assessed with the Quality Assessment of Diagnostic Accuracy Studies tool (QUADAS-2) and COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist for criterion validity. When possible, a meta-analysis was performed. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) recommendations were applied to establish the level of evidence per measurement instrument. RESULTS: From 3450 articles identified, 31 articles were included in this review. Eleven measurement instruments for migraine were identified, of which the ID-Migraine is recommended with a moderate level of evidence and a pooled sensitivity of 0.87 (95% CI: 0.85-0.89) and specificity of 0.75 (95% CI: 0.72-0.78). Six measurement instruments examined both migraine and tension-type headache and only the Headache Screening Questionnaire - Dutch version has a moderate level of evidence with a sensitivity of 0.69 (95% CI 0.55-0.80) and specificity of 0.90 (95% CI 0.77-0.96) for migraine, and a sensitivity of 0.36 (95% CI 0.21-0.54) and specificity of 0.86 (95% CI 0.74-0.92) for tension-type headache. For cervicogenic headache, only the cervical flexion rotation test was identified and had a very low level of evidence with a pooled sensitivity of 0.83 (95% CI 0.72-0.94) and specificity of 0.82 (95% CI 0.73-0.91). DISCUSSION: The current review is the first to establish an overview of the diagnostic accuracy of measurement instruments for headaches associated with musculoskeletal factors. However, as most measurement instruments were validated in one study, pooling was not always possible. Risk of bias was a serious problem for most studies, decreasing the level of evidence. More research is needed to enhance the level of evidence for existing measurement instruments for multiple headaches.

Functional performance and safety of bone-anchored prostheses in persons with a transfemoral or transtibial amputation: a prospective one-year follow-up cohort study.

OBJECTIVES:: (1) To compare level of function, activity, health-related quality of life (HRQoL) and satisfaction in persons with a lower extremity amputation before surgery and 6- and 12-months after implantation of an osseointegration implant and (2) to report adverse events. DESIGN:: Prospective cohort study. SETTING:: University medical centre. SUBJECTS:: A total of 40 consecutive persons (median age: 56 years) who received a transfemoral (31) or transtibial (9) osseointegration implant, between April 2014 and March 2016. INTERVENTION:: Osseointegration implant surgery followed by a predefined rehabilitation programme. MAIN MEASURES:: Hip abductor strength, prosthetic use, back pain frequency, postoperative pain, mobility level (Timed-Up and Go (TUG) and wheelchair-boundedness), walking ability (6 minute walking test (6MWT) and walking distance in daily life), HRQoL, satisfaction regarding the prosthesis, and adverse events. RESULTS:: Strength, prosthetic use, walking distance, HRQoL, and satisfaction level increased significantly at 6- and 12-month follow-up compared to baseline ( P ⩽ 0.002). The TUG showed no change at 6-month follow-up ( P = 0.420) but improved significantly at 12-month follow-up compared to baseline ( P = 0.005). Wheelchair-boundedness decreased from 12/40 participants at baseline to 0 at follow-ups. The 6MWT ( P ⩾ 0.038) and back pain ( P ⩾ 0.437) did not change over time. Stump pain was present in 28/39 and 22/40 of the participants at 6-and 12-month follow-up, respectively. The major adverse events were managed successfully and included three dual-cone breakages and four bone fractures. An uneventful course was completed by 19/31 transfemoral and 4/9 transtibial bone-anchored prostheses users. CONCLUSION:: Bone-anchored prostheses lead to improved performance and appear to be safe, so they might be considered for persons with socket-related problems.

Pain Exposure Physical Therapy versus conventional treatment in complex regional pain syndrome type 1-a cost-effectiveness analysis alongside a randomized controlled trial.

OBJECTIVE: To analyze cost-effectiveness of Pain Exposure Physical Therapy compared to conventional treatment alongside a randomized controlled trial (NCT00817128) in patients with complex regional pain syndrome type 1, where no clinical difference was shown between the two groups in an intention-to-treat analysis. DESIGN: Randomized controlled trial with 9 months follow-up. SETTING: Patients were recruited from hospitals and general practitioners in the region around a university hospital. SUBJECTS: A total of 56 patients, 45 (80.4%) female, were randomized. About 4 patients in the intervention and 11 patients in the conventional group switched groups. The mean (SD) age was 44.3 (16.6) years, and in 37 (66.1%) patients, the upper extremity was affected. INTERVENTIONS: Patients received either Pain Exposure Physical Therapy (maximum of five sessions), or conventional treatment conforming with the Dutch multidisciplinary guideline. MAIN MEASURES: For the economic evaluation difference between the groups in health-related quality of life (quality-adjusted life years (QALYs)), and the clinical outcomes Impairment level Sum Score-Restricted Version and Pain Disability was determined based on the intention-to-treat analysis as well as differences in both healthcare-related costs and travel expenses. Cost-effectiveness planes were constructed using bootstrapping to compare effects and costs. RESULTS: No significant effects were found for QALYs (mean difference = -0.02; 95% confidence interval (CI) -0.10 to 0.04) and clinical outcomes. A cost minimization analysis showed a significant difference in costs between groups. The conventional treatment was 64% more expensive than the Pain Exposure Physical Therapy. CONCLUSION: This economic analysis shows that Pain Exposure Physical Therapy compared to conventional treatment is cost-effective.

Effect and Process Evaluation of e-Powered Parents, a Web-Based Support Program for Parents of Children With a Chronic Kidney Disease: Feasibility Randomized Controlled Trial.

BACKGROUND: Parents of children with chronic kidney disease (CKD) experience high levels of stress in the daily management of their child's illness. Parents need continuously available support and information, yet online support programs are lacking. e-Powered Parents was developed to fill this gap; it is an online program consisting of (1) medical information, (2) an interactive part, and (3) four training modules (stress management, setting limits, communication, and coping). Prior to a large-scale evaluation, we conducted a feasibility study that consisted of an effect study and a process evaluation. OBJECTIVE: The objectives of our study were to (1) identify the outcome measures that are most likely to capture the potential benefit, (2) evaluate the potential effectiveness and effect size, and (3) evaluate recruitment, reach, the dose received, and context. METHODS: We conducted a feasibility study with a two-armed, wait-list randomized controlled trial (RCT). Prior to baseline, parents (n=146) were randomly allocated to group 1 or group 2. After completing the baseline questionnaire, parents in group 1 were given access to e-Powered Parents, while those in group 2 received usual care. At the 6-month follow-up (T1), all parents received a questionnaire and parents in group 2 were given access to e-Powered Parents as well. After 1.5 years, through an extra measurement (T2), we evaluated the effect of long-term exposure. Outcomes were the child's quality of life (Child Vulnerability Scale), parental stress (Pediatric Inventory for Parents) and fatigue (Multidimensional Fatigue Inventory), self-efficacy in communication with health care professionals (Perceived Efficacy in Patient-Physician Interactions, PEPPI-5), and parental perceptions of family management (Family Management Measure). Floor and ceiling effects and percentage of parents showing no change in scores were calculated. We used linear mixed models to evaluate the potential effectiveness and effect sizes using the intention-to-treat and per-protocol analyses. In the process evaluation, we evaluated recruitment, reach, the dose received, and context using a questionnaire sent to the parents, log-in data, and a focus group interview with health care professionals. RESULTS: At T1 (n=86) and T2 (n=51), no significant effects were found on any of the five outcomes. The PEPPI-5 showed ceiling effects and high percentages of parents showing no change between the measurement times. The information and interactive part of the intervention were used by 84% (57/68) of the parents in group 1 and 49% (32/65) of the parents in group 2. The information pages were visited most often. Overall, 64% (85/133) of the parents logged in to the training platform and 31% (26/85) actually used the training modules. CONCLUSIONS: We did not observe any significant effect on any of the outcomes. This could possibly be explained by the minimal use of the intervention and by parents' heterogeneity. For continued participation, we recommend a tailored intervention and further studies to find out whether and how online programs could be used to support parents in the management of their child's CKD. TRIAL REGISTRATION: Netherlands Trial Registry NTR4808; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4808 (Archived by WebCite at http://www.webcitation.org/719rCicvW).

What environmental factors influence resumption of valued activities post stroke: a systematic review of qualitative and quantitative findings.

OBJECTIVE: Identify the environmental factors that influence stroke-survivors' reengagement in personally valued activities and determine what specific environmental factors are related to specific valued activity types. DATA SOURCES: PubMed, CINAHL and PsycINFO were searched until June 2016 using multiple search-terms for stroke, activities, disability, and home and community environments. REVIEW METHODS: An integrated mixed-method systematic review of qualitative, quantitative and mixed-design studies was conducted. Two researchers independently identified relevant studies, assessed their methodological quality and extracted relevant findings. To validly compare and combine the various findings, all findings were classified and grouped by environmental category and level of evidence. RESULTS: The search yielded 4024 records; 69 studies were included. Most findings came from low-evidence-level studies such as single qualitative studies. All findings were consistent in that the following factors facilitated reengagement post-stroke: personal adapted equipment; accessible environments; transport; services; education and information. Barriers were: others' negative attitudes and behaviour; long distances and inconvenient environmental conditions (such as bad weather). Each type of valued activity, such as mobility or work, had its own pattern of environmental influences, social support was a facilitator to all types of activities. Although in many qualitative studies others' attitudes, behaviour and stroke-related knowledge were seen as important for reengagement, these factors were hardly studied quantitatively. CONCLUSION: A diversity of environmental factors was related to stroke-survivors' reengagement. Most findings came from low-evidence-level studies so that evidence on causal relationships was scarce. In future, more higher-level-evidence studies, for example on the attitudes of significant others, should be conducted.

Physical therapists and importance of work participation in patients with musculoskeletal disorders: a focus group study.

BACKGROUND: Musculoskeletal disorders are a major health problem resulting in negative effects on wellbeing and substantial costs to society. Work participation is associated with positive benefits for both mental and physical health. Potentially, generalist physical therapists (GPTs) can play an important role in reducing absenteeism, presenteeism and associated costs in patients with musculoskeletal disorders. However, work participation is often insufficiently addressed within generalist physical therapy practice (GPTP). Therefore, this study evaluates whether GPTs take work participation into account as a determining factor in patients with musculoskeletal disorders, and how this might be improved. METHODS: This qualitative study consisted of seven focus groups involving 30 participants: 21 GPTs and 9 occupational physical therapists (OPTs). Based on an interview guide, participants were asked how they integrate work participation within their practice, how they collaborate with other professionals, and how GPTs can improve integration of the patient's work within their practice. RESULTS: Although participants recognized the importance of work participation, they mentioned that the integration of this item in their GPTP could be improved. Generally, GPTs place insufficient priority on work participation. Moreover, there is a lack of cooperation between the generalist physical therapist and (other) occupational healthcare providers (including OPTs), and the borderlines/differences between generalist physcial therapy and occupational health physcial therapy were sometimes unclear. GPTs showed a lack of knowledge and a need for additional information about several important work-related factors (e.g. work content, physical and psychosocial working conditions, terms of employment). CONCLUSIONS: Although a patient's work is important, GPTs take insufficient account of work participation as a determining factor in the treatment of patients with musculoskeletal disorders. GPTs often lack specific knowledge about work-related factors, and there is insufficient cooperation between OPTs and other occupational healthcare providers. The integration of work participation within GPTP, and the cooperation between GPTs and other occupational healthcare providers, show room for improvement.

A process evaluation of a home-based occupational therapy intervention for Parkinson's patients and their caregivers performed alongside a randomized controlled trial.

OBJECTIVE: To evaluate fidelity, treatment enactment and the experiences of an occupational therapy intervention in Parkinson's disease, to identify factors that affect intervention delivery and benefits. DESIGN: Mixed methods alongside a randomized controlled trial. SUBJECTS: These include 124 home-dwelling Parkinson's disease patients and their primary caregivers (recipients), and 18 occupational therapists. INTERVENTION: Ten-week home-based intervention according to the Dutch guidelines for occupational therapy in Parkinson's disease. MAIN MEASURES: Data were collected on intervention dose, protocol process, content of treatment (fidelity), offered and performed strategies (treatment enactment), and recipients' experiences. Therapists' experiences were collected through case note analyses and focus group interviews. RESULTS: Mean intervention dose was 9.3 (SD 2.3) hours. Mean protocol process adherence was high (93%; SD 9%), however the intervention did not (fully) address the goal for 268 of 617 treatment goals. Frequencies of offered and performed strategies appeared similar, apart from 'using other tools and materials' which showed a drop from 279 advised to 149 used. The recipients were satisfied overall with the intervention (mean score 8 out of 10). The therapists noted positive or negative influencing factors on both process and benefits: the research context, the socio-political healthcare context, the recipients' personal and contextual factors, and the therapists' competence. CONCLUSION: We found some prerequisite factors in equipment provision and available dose important for treatment delivery. Other elicited factors related to, or affected, the required professional competencies and tools to tailor interventions to the complexity of interacting personal and contextual factors of patients and caregivers.

Multifaceted interventions are required to improve physical activity behaviour in hospital care: a meta-ethnographic synthesis of qualitative research.

QUESTION: What are the views of patients, close relatives and healthcare professionals on physical activity behaviour in hospital care? METHODS: A meta-ethnographic synthesis of qualitative studies was conducted with a lines-of-argument analysis. The methodological quality of included studies was evaluated using the Critical Appraisal Skills Programme (CASP) checklist. The lines of argument were synthesised and mapped in an existing theoretical model. The confidence of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation Confidence in Evidence from Reviews of Qualitative Research (GRADE-CERQual) approach. RESULTS: Eleven studies were included and provided data from 290 participants (145 patients, 0 close relatives and 145 healthcare professionals). We have synthesised six lines of argument that explained the (intention of) physical activity behaviour of patients during their hospital stay: patients and healthcare professionals perceive benefits and risks of physical activity for patients' health (high confidence); physical activity gives a sense of freedom, confidence in recovery and mental wellbeing (high confidence); all healthcare professionals should offer timely and tailored physical activity promotion (high confidence); patient motivation to be physically active may be contingent upon encouragement (moderate confidence); family members can influence physical activity behaviour favourably or unfavourably (low confidence); and hospital culture has a negative influence on physical activity behaviour of patients (high confidence). CONCLUSIONS: Physical activity behaviour of patients during their hospital stay is a complex phenomenon with multiple interactions at the level of patients, healthcare professionals and hospital culture. Considering the results of this synthesis, multifaceted implementation strategies are needed to improve physical activity intention and behaviour of patients during their hospital stay.

Mixed methods evaluation of a self-management group programme for patients with neuromuscular disease and chronic fatigue.

OBJECTIVE: To obtain insight into experiences of patients with a neuromuscular disease and chronic fatigue and their healthcare professionals regarding content and delivery of a multidisciplinary outpatient self-management group programme to improve social participation. This will inform future implementation. DESIGN: A mixed method study alongside a randomised controlled trial. SETTING: University hospital, rehabilitation centre and community health centre. PARTICIPANTS: 29 patients with a neuromuscular disease and chronic fatigue and 13 healthcare professionals participated in this mixed methods study. INTERVENTION: Multidisciplinary group programme, called Energetic, consisted of a 4 months intervention with weekly meetings and covered four modules: (1) individually tailored aerobic exercise training; (2) education about aerobic exercise; (3) self-management training in applying energy conservation strategies and (4) implementation and relapse prevention in daily life. MAIN MEASURES: Quantitative data were collected by a questionnaire measuring patients' (n=25, all completed the programme) satisfaction with the perceived results, content and delivery of the programme. Qualitative data were collected by individual and focus group interviews to gain insight in the experiences of patients (n=18), next of kin (n=2) and healthcare professionals (n=13) with facilitators and barriers to programme implementation. RESULTS: Patients were satisfied with the number and length of the sessions, the different modules and the therapists. Analysis of the interviews led to five themes: (1) the combination of modules makes a complete picture, (2) the programme is physically and mentally intensive, (3) the group setting is valuable, (4) small variations in delivery occur in different settings, (5) therapists are coaches. Suggestions for programme improvement include a combination of face to face and e-health, enhancement of therapists' skills in guiding group interventions and inclusion of more booster sessions to evaluate and maintain self-management competencies. CONCLUSIONS: The Energetic programme could be implemented in different healthcare settings and group settings, and a combination of modules proved to be a facilitator for improving self-management. TRIAL REGISTRATION NUMBER: NCT02208687.

Effects of physical therapy for temporomandibular disorders on headache pain intensity: A systematic review.

BACKGROUND: Physical therapy is regarded an effective treatment for temporomandibular disorders (TMD). Patients with TMD often report concomitant headache. There is, however, no overview of the effect of physical therapy for TMD on concomitant headache complaints. OBJECTIVES: The aim of this study is to systematically evaluate the literature on the effectiveness of physical therapy on concomitant headache pain intensity in patients with TMD. DATA SOURCES: PubMed, Cochrane and PEDro were searched. STUDY ELIGIBILITY CRITERIA: Randomized or controlled clinical trials studying physical therapy interventions were included. PARTICIPANTS: Patients with TMD and headache. APPRAISAL: The Cochrane risk of bias tool was used to assess risk of bias. SYNTHESIS METHODS: Individual and pooled between-group effect sizes were calculated according to the standardized mean difference (SMD) and the quality of the evidence was rated using the GRADE approach. RESULTS: and manual therapy on both orofacial region and cervical spine. There is a very low level of certainty that TMD-treatment is effective on headache pain intensity, downgraded by high risk of bias, inconsistency and imprecision. LIMITATIONS: The methodological quality of most included articles was poor, and the interventions included were very different. CONCLUSIONS: Physical therapy interventions presented small effect on reducing headache pain intensity on subjects with TMD, with low level of certainty. More studies of higher methodological quality are needed so better conclusions could be taken.

Development of a Standard Set of Outcome Domains and Proposed Measures for Chronic Obstructive Pulmonary Disease in Primary Care Physical Therapy Practice in the Netherlands: a Modified RAND/UCLA Appropriateness Method.

Background: Standardization of measures in a common set opens the opportunity to learn from differences in treatment outcomes which can be used for improving the quality of care. Furthermore, a standard set can provide the basis for development of quality indicators and is therefore useful for quality improvement and public reporting purposes. The aim of this study was to develop a standard set of outcome domains and proposed measures for patients with COPD in Dutch primary care physical therapy practice, including a proposal to stratify patients in subgroups. Material and methods: A consensus-driven modified RAND-UCLA appropriateness method was conducted with relevant stakeholders (patients, physical therapists, researchers, policy makers and health insurers) in Dutch primary physical therapy care in eight steps: (1) literature search, (2) first online survey, (3) patient interviews, (4) expert meeting, resulting in a concept standard set and methods to identify subgroups' (5) consensus meeting, (6) expert meeting (7) second online survey and (8) final approval of an advisory board resulting of the approved standard set. Results: Five outcome domains were selected for COPD: physical capacity, muscle strength, physical activity, dyspnea and quality of life. A total of 21 measures were rated and discussed. Finally, eight measures were included, of which four mandatory measures: Characteristics of practices and physical therapists, Clinical COPD Questionnaire (CCQ) for quality of life, Global Perceived Effect (GPE) for experience, 6-mins Walk Test (6-MWT) for physical capacity; two conditional measures: Hand-Held Dynamometer (HHD) (with Microfet™) for Quadriceps strength, Medical Research Council Dyspnea (MRC) for monitoring dyspnea; and two exploratory measures: Accelerometry for physical activity, and the Assessment of Burden of COPD tool (ABC). To identify subgroups, a method described in the Dutch standard of care from the Lung Alliance was included. Conclusion: This study described the development of a standard set of outcome domains and proposed measures for patients with COPD in primary care physical therapy. Each measure was accepted for relevance and feasibility by the involved stakeholders. The set is currently used in daily practice and tested on validity and reliability in a pilot for the development of quality indicators.

Gait rehabilitation for a patient with an osseointegrated prosthesis following transfemoral amputation.

BACKGROUND: In patients with a transfemoral amputation socket-related problems are associated with reduced prosthetic use, activity, and quality of life. Furthermore, gait asymmetries are present that may explain secondary complaints. Bone-anchored prostheses (BAPs) may help these patients. Two types of BAP are available, screw and press-fit implants. Rehabilitation following surgery for a press-fit BAP is poorly described. PURPOSE: To describe a rehabilitation program designed to minimize compensation strategies and increase activity using a case-report of an active, 70-year-old man with a traumatic transfemoral amputation who had used a socket prosthesis for 52 years and received a press-fit BAP [Endo-Exo Femoral Prosthesis - EEFP]. INTERVENTION: A 13-week physiotherapy program. OUTCOMES: Outcomes were assessed before surgery, at the end of rehabilitation, and six-month and one-year follow-ups. After rehabilitation gait had improved, the patient had more arm movement, more pelvic shift, less hip rotation during swing phase on the prosthetic side, and absence of vaulting on the sound side. Isometric hip abductor strength was 15% higher on the sound side and 16% higher on the prosthetic side, and walking distance increased from 200 m to 1500 m. At the six-month follow-up, the patient had lower back complications and reduced hip abductor strength and walking distance. At one-year follow-up, walking distance had recovered to 1000 m and gait pattern had improved again, with yielding and absence of terminal impact on the prosthetic side. CONCLUSION: The described rehabilitation program may be an effective method of improving gait in patients with an EEFP even after long-term socket usage.

Self-Management Support Program for Patients With Cardiovascular Diseases: User-Centered Development of the Tailored, Web-Based Program Vascular View.

BACKGROUND: In addition to medical intervention and counseling, patients with cardiovascular disease (CVD) need to manage their disease and its consequences by themselves in daily life. OBJECTIVE: The aim of this paper is to describe the development of "Vascular View," a comprehensive, multi-component, tailored, Web-based, self-management support program for patients with CVD, and how this program will be tested in an early randomized controlled trial (RCT). METHODS: The Vascular View program was systematically developed in collaboration with an expert group of 6 patients, and separately with a group of 6 health professionals (medical, nursing, and allied health care professionals), according to the following steps of the intervention mapping (IM) framework: (1) conducting a needs assessment; (2) creating matrices of change objectives; (3) selecting theory-based intervention methods and practical applications; (4) organizing methods and applications into an intervention program; (5) planning the adaption, implementation, and sustainability of the program, and (6) generating an evaluation plan. RESULTS: The needs assessment (Step 1) identified 9 general health problems and 8 determinants (knowledge, awareness, attitude, self-efficacy, subjective norm, intention, risk perception, and habits) of self-managing CVD. By defining performance and change objectives (Step 2), 6 topics were distinguished and incorporated into the courses included in Vascular View (Steps 3 and 4): (1) Coping With CVD and its Consequences; (2) Setting Boundaries in Daily Life; (3) Lifestyle (general and tobacco and harmful alcohol use); (4) Healthy Nutrition; (5) Being Physically Active in a Healthy Way; and (6) Interaction With Health Professionals. These courses were based on behavioral change techniques (BCTs) (eg, self-monitoring of behavior, modeling, re-evaluation of outcomes), which were incorporated in the courses through general written information: quotes from and videos of patients with CVD as role models and personalized feedback, diaries, and exercises. The adoption and implementation plan (Step 5) was set up in collaboration with the members of the two expert groups and consisted of a written and digital instruction manual, a flyer, bimonthly newsletters, and reminders by email and telephone to (re-)visit the program. The potential effectiveness of Vascular View will be evaluated (Step 6) in an early RCT to gain insight into relevant outcome variables and related effect sizes, and a process evaluation to identify intervention fidelity, potential working mechanisms, user statistics, and/or satisfaction. CONCLUSION: A comprehensive, multi-component, tailored, Web-based, self-management support program and an early RCT were developed in order to empower patients to self-manage their CVD. TRIAL REGISTRATION: Nederlands Trial Register NTR5412; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5412 (Archived by WebCite at http://www.webcitation.org/6jeUFVj40).

Development of a self-management program for employees with complaints of the arm, neck, and/or shoulder: an intervention mapping approach.

PURPOSE: To develop a self-management program with an additional eHealth module, using the six steps of the intervention mapping (IM) protocol, to help employees with complaints of the arm, neck, and/or shoulder (CANS) cope with their problems. METHODS: In Step 1 of the IM protocol, a needs assessment was performed consisting of a review of the Dutch multidisciplinary guidelines on CANS, and of focus group sessions with employees with CANS (n=15) and with relevant experts (n=17). After the needs assessment, the objectives of the intervention and the determinants of self-management at work were formulated (Step 2). Furthermore, theory-based intervention methods and practical strategies were selected (Step 3), and an intervention program (including the eHealth module) was developed (Step 4). Finally, plans for implementation and evaluation of the program were developed (Steps 5 and 6). RESULTS: Step 1 of the IM protocol revealed that employees with CANS should be stimulated to search for information about the cause of their complaints, about how to deal with their complaints, and in which manner they can influence their complaints themselves. In Step 2, the overall goal of the intervention was defined as "self-management behavior at work" with the aim to alleviate the perceived disability of the participants. Step 3 described how the intervention methods were translated into practical strategies, and goal setting was introduced as an important method for increasing self-efficacy. The product of Step 4 was the final program plan, consisting of 6-weekly group sessions of 2.5 hours each and an eHealth module. In Step 5, a recruitment plan and course materials were developed, a steering committee was set up, trainers were recruited, and the final program was tested. In Step 6, an evaluation plan was developed, which consists of a randomized controlled trial with a 12-month follow-up period and a qualitative evaluation (interviews) with some of the participants. CONCLUSION: This study resulted in a theory- and practice-based self-management program, based on behavioral change theories, guideline-related evidence, and practice-based knowledge that fits the needs of employees with CANS.