Unravelling effectiveness of a nurse-led behaviour change intervention to enhance physical activity in patients at risk for cardiovascular disease in primary care: study protocol for a cluster randomised controlled trial

BACKGROUND: Self-management interventions are considered effective in patients with chronic disease, but trials have shown inconsistent results, and it is unknown which patients benefit most. Adequate self-management requires behaviour change in both patients and health care providers. Therefore, the Activate intervention was developed with a focus on behaviour change in both patients and nurses. The intervention aims for change in a single self-management behaviour, namely physical activity, in primary care patients at risk for cardiovascular disease. The aim of this study is to evaluate the effectiveness of the Activate intervention. METHODS/DESIGN: A two-arm cluster randomised controlled trial will be conducted to compare the Activate intervention with care as usual at 31 general practices in the Netherlands. Approximately 279 patients at risk for cardiovascular disease will participate. The Activate intervention is developed using the Behaviour Change Wheel and consists of 4 nurse-led consultations in a 3-month period, integrating 17 behaviour change techniques. The Behaviour Change Wheel was also applied to analyse what behaviour change is needed in nurses to deliver the intervention adequately. This resulted in 1-day training and coaching sessions (including 21 behaviour change techniques). The primary outcome is physical activity, measured as the number of minutes of moderate to vigorous physical activity using an accelerometer. Potential effect modifiers are age, body mass index, level of education, social support, depression, patient-provider relationship and baseline number of minutes of physical activity. Data will be collected at baseline and at 3 months and 6 months of follow-up. A process evaluation will be conducted to evaluate the training of nurses, treatment fidelity, and to identify barriers to and facilitators of implementation as well as to assess participants' satisfaction. DISCUSSION: To increase physical activity in patients and to support nurses in delivering the intervention, behaviour change techniques are applied to change behaviours of the patients and nurses. Evaluation of the effectiveness of the intervention, exploration of which patients benefit most, and evaluation of our theory-based training for primary care nurses will enhance understanding of what works and for whom, which is essential for further implementation of self-management in clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02725203 . Registered on 25 March 2016

Physical Activity during Cancer Treatment (PACT) Study: design of a randomised clinical trial

<p>Abstract</p> <p>Background</p> <p>Fatigue is a major problem of cancer patients. Thirty percent of cancer survivors report serious fatigue three years after finishing treatment. There is evidence that physical exercise during cancer treatment reduces fatigue. This may also lead to an improvement of quality of life. Such findings may result in a decrease of healthcare related expenditures and societal costs due to sick leave. However, no studies are known that investigated these hypotheses. Therefore, the primary aim of our study is to assess the effect of exercise during cancer treatment on reducing complaints of fatigue and on reducing health service utilisation and sick leave.</p> <p>Methods/Design</p> <p>The Physical Activity during Cancer Treatment study is a multicentre randomised controlled trial in 150 breast and 150 colon cancer patients undergoing cancer treatment. Participants will be randomised to an exercise or a control group. In addition to the usual care, the exercise group will participate in an 18-week supervised group exercise programme. The control group will be asked to maintain their habitual physical activity pattern. Study endpoints will be assessed after 18 weeks (short term) and after 9 months (long term). Validated questionnaires will be used. Primary outcome: fatigue (Multidimensional Fatigue Inventory and Fatigue Quality List) and cost-effectiveness, health service utilisation and sick leave. Secondary outcome: health related quality of life (European Organisation Research and Treatment of Cancer-Quality of Life questionnaire-C30, Short Form 36 healthy survey), impact on functioning and autonomy (Impact on functioning and autonomy questionnaire), anxiety and depression (Hospital Anxiety and Depression Scale), physical fitness (aerobic peak capacity, muscle strength), body composition and cognitive-behavioural aspects. To register health service utilisation and sick leave, participants will keep diaries including the EuroQuol-5D. Physical activity level will be measured using the Short Questionnaire to Assess Health-Enhancing Physical Activity and will be monitored with an exercise log and a pedometer.</p> <p>Discussion</p> <p>This study investigates the (cost)-effectiveness of exercise during adjuvant treatment of patients with breast or colon cancer. If early physical exercise proves to be (cost) effective, establishing standardised physical exercise programmes during cancer treatment will be planned.</p> <p>Trial registration</p> <p>Current Controlled trials ISRCTN43801571, Dutch Trial Register NTR2138</p

Cross-cultural adaptation and measurement properties of the Brief Illness Perception Questionnaire-Dutch Language Version

OBJECTIVE: Ever since Engel's Biopsychosocial Model (1977) emotions, thoughts, beliefs and behaviors are accepted as important factors of health. The Brief Illness Perception Questionnaire (Brief IPQ) assesses these beliefs. Aim of this study was to cross-culturally adapt the Brief IPQ into the Brief IPQ Dutch Language Version (Brief IPQ-DLV), and to assess its face validity, content validity, reproducibility, and concurrent validity. METHODS: Beaton's guideline was used for cross-culturally adaptation. Face and content validity were assessed in 25 patients, 15 physiotherapists and 24 first-grade students. Reproducibility was established in 27 individuals with chronic obstructive pulmonary disease using Cohen's kappa coefficient (K(w)) and the Smallest Detectable Change (SDC). Concurrent validity was assessed in 163 patients visiting 11 different physical therapists. RESULTS: The Brief IPQ-DLV is well understood by patients, health care professionals and first-grade students. Reliability at 1 week for the dimensions Consequences, Concern and Emotional response K(w)>0.70, for the dimensions Personal control, Treatment control, Identity, K(w)<0.70. A time interval of 3 weeks, reliability coefficients were lower for almost all dimensions. SDC was between 2.45 and 3.37 points for individual measurement purposes and between 0.47 and 0.57 points for group evaluative measurement purposes. Concurrent validity showed significant correlations (P<.05) for four out of eight illness perceptions (IPs) dimensions. CONCLUSION: The face and content properties were found to be acceptable. The reproducibility and concurrent validity needs further investigate

Fidelity of primary care nurses’ delivery of a behavioural change intervention enhancing physical activity in patients at risk of cardiovascular disease: an observational study

Objective To evaluate the fidelity of delivery of a nurse-led intervention to enhance physical activity in patients at risk for cardiovascular diseases, the Activate intervention, by assessing: (1) self-reported fidelity of delivery; (2) observed fidelity of delivery; (3) quality of delivery of the Activate intervention and (4) nurses’ beliefs about their capability, motivation, confidence and effectiveness towards delivering the Activate intervention, including behavioural change techniques.Design An observational study.Setting General practices in the Netherlands.Participants Primary care nurses (n=20) from 16 general practices.Primary and secondary outcome measures Nurses’ self-reported fidelity was evaluated using checklists (n=282), and the observed fidelity and quality of delivery were examined using audiorecordings of consultations of the delivery of the Activate intervention (n=42). Nurses’ beliefs towards delivering the intervention were assessed using questionnaires (n=72).Results The self-reported fidelity was 88.1% and observed fidelity was 85.4%, representing high fidelity. The observed fidelity of applied behavioural change techniques was moderate (75.0%). The observed quality of delivery was sufficient and varied among nurses (mean 2.9; SD 4.4; range 0–4). Nurses’ beliefs about their capability, motivation, confidence and effectiveness towards delivering the intervention increased over time.Conclusions Nurses delivered most intervention components as intended with sufficient quality. Nurses believed they were capable, motivated and confident to deliver the intervention. They believed the intervention was effective to increase patients’ physical activity level. Despite the high fidelity and moderate fidelity of applied behavioural change techniques, the varying quality of delivery within and across nurses might have diluted the effectiveness of the Activate intervention.Trial registration number NCT02725203

Encouraging post-stroke patients to be active seems possible : results of an intervention study with knowledge brokers

Purpose : Although physical activity and exercise for stroke patients is highly recommended for fast recovery, patients in hospitals and rehabilitation centres are insufficiently encouraged to be physically active. In this study, we investigated the impact of knowledge brokers (KBs), enterprising nurses and therapists, on health professionals’ (HP) performance to encourage stroke inpatients to be physically active.  Method : This multicenter intervention study used a pre–post test design. Two or three KBs were trained in each stroke unit of 12 hospitals and 10 rehabilitation centres in The Netherlands. Questionnaires were completed by patients and HPs before and after the KB-intervention. The primary outcome was encouragement given by HPs to their patients to be physically active, as reported by patients and HPs.  Results : After the KB-intervention, many more patients (48%; N=217) reported at least some encouragement by HPs to be physically active than before (26%; N=243, p<0.000). HPs (N=288) on an average reported encouraging patients more often after the intervention, but this difference was significant only for occupational therapists and KBs.  Conclusions : Based on patient’s reports of HP behaviour, the KB-intervention appears effective since more patients felt encouraged to be physically active after the intervention compared to before. Replication of this study in an experimental design is needed to allow causal inferences. Implications for rehabilitation We advise rehabilitation teams to make use of knowledge brokers (KBs), since the KB-intervention was shown to increase the encouragement felt by stroke patients to be physically active. It seems worthwhile to involve physicians, nurses and patients’ families more frequently in efforts to encourage stroke patients to be physically active