Minimal Intervention Needed for Change: Definition, Use, and Value for Improving Health and Health Research

Much research focuses on producing maximal intervention effects. This has generally not resulted in interventions being rapidly or widely adopted or seen as feasible given resources, time, and expertise constraints in the majority of real-world settings. We present a definition and key characteristics of a minimum intervention needed to produce change (MINC). To illustrate use of a MINC condition, we describe a computer-assisted, interactive minimal intervention, titled Healthy Habits, used in three different controlled studies and its effects. This minimal intervention produced modest to sizable health behavior and psychosocial improvements, depending on the intensity of personal contacts, producing larger effects at longer-term assessments. MINC comparison conditions could help to advance both health care and health research, especially comparative effectiveness research. Policy and funding implications of requiring an intervention to be demonstrated more effective than a simpler, less costly MINC alternative are discussedYe

Telecare motivational interviewing for diabetes patient education and support : a randomised controlled trial based in primary care comparing nurse and peer supporter delivery

Background: There is increasing interest in developing peer-led and 'expert patient'-type interventions, particularly to meet the support and informational needs of those with long term conditions, leading to improved clinical outcomes, and pressure relief on mainstream health services. There is also increasing interest in telephone support, due to its greater accessibility and potential availability than face to face provided support. The evidence base for peer telephone interventions is relatively weak, although such services are widely available as support lines provided by user groups and other charitable services. Methods/Design: In a 3-arm RCT, participants are allocated to either an intervention group with Telecare service provided by a Diabetes Specialist Nurse (DSN), an intervention group with service provided by a peer supporter (also living with diabetes), or a control group receiving routine care only. All supporters underwent a 2-day training in motivational interviewing, empowerment and active listening skills to provide telephone support over a period of up to 6 months to adults with poorly controlled type 2 diabetes who had been recommended a change in diabetes management (i.e. medication and/or lifestyle changes) by their general practitioner (GP). The primary outcome is self-efficacy; secondary outcomes include HbA1c, total and HDL cholesterol, blood pressure, body mass index, and adherence to treatment. 375 participants (125 in each arm) were sought from GP practices across West Midlands, to detect a difference in self-efficacy scores with an effect size of 0.35, 80% power, and 5% significance level. Adults living with type 2 diabetes, with an HbA1c > 8% and not taking insulin were initially eligible. A protocol change 10 months into the recruitment resulted in a change of eligibility by reducing HbA1c to > 7.4%. Several qualitative studies are being conducted alongside the main RCT to describe patient, telecare supporter and practice nurse experience of the trial. Discussion and implications of the research: With its focus on self-management and telephone peer support, the intervention being trialled has the potential to support improved self-efficacy and patient experience, improved clinical outcomes and a reduction in diabetes-related complications

Process evaluation of a school based physical activity related injury prevention programme using the RE-AIM framework

<p>Abstract</p> <p>Background</p> <p>In general, only information regarding the effectiveness of an intervention programme is ever published. However, in recent years evaluating the translatability and feasibility of an intervention programme has become more important. Therefore, this paper presents the results of the evaluation of the iPlay programme aimed at preventing physical activity related injuries in primary school children.</p> <p>Methods</p> <p>The iPlay programme targeted injuries gained through physical activity, and consisted of a teacher's manual, informative newsletters and posters, a website, and set exercises to be carried out during physical education (PE) classes. In order to evaluate the iPlay programme for translatability and feasibility, teachers, children and parents who participated in the iPlay programme filled out a questionnaire</p> <p>The objective of this study is to describe the results of the process-evaluation of the iPlay programme based on the five dimensions of the RE-AIM framework.</p> <p>Results</p> <p>The results showed that the participation rate of the children was 100% (reach). Nine percent of the schools who were invited to take part were willing to participate in the study (adoption rate). Teachers stated that they implemented the different elements of the programme partly as intended (implementation). The percentage of children and parents who followed the programme was less than expected. In addition, 52% of the teachers indicated that the current iPlay programme could become standard practice in their teaching routine (maintenance).</p> <p>Conclusion</p> <p>The iPlay programme is a first start in the prevention of physical activity related injuries in children, but further improvements need to be made to the programme on the basis of this process evaluation.</p> <p>Trial registration</p> <p>ISRCTN78846684; <url>http://www.controlled-trials.com</url></p

Evaluating Active U: an Internet-mediated physical activity program.

Background: Engaging in regular physical activity can be challenging, particularly during the winter months. To promote physical activity at the University of Michigan during the winter months, an eight-week Internet-mediated program (Active U) was developed providing participants with an online physical activity log, goal setting, motivational emails, and optional team participation and competition. Methods: This study is a program evaluation of Active U. Approximately 47,000 faculty, staff, and graduate students were invited to participate in the online Active U intervention in the winter of 2007. Participants were assigned a physical activity goal and were asked to record each physical activity episode into the activity log for eight weeks. Statistics for program reach, effectiveness, adoption, and implementation were calculated using the Re-Aim framework. Multilevel regression analyses were used to assess the decline in rates of data entry and goal attainment during the program, to assess the likelihood of joining a team by demographic characteristics, to test the association between various predictors and the number of weeks an individual met his or her goal, and to analyze server load. Results: Overall, 7,483 individuals registered with the Active U website (≈16% of eligible), and 79% participated in the program by logging valid data at least once. Staff members, older participants, and those with a BMI < 25 were more likely to meet their weekly physical activity goals, and average rate of meeting goals was higher among participants who joined a competitive team compared to those who participated individually (IRR = 1.28, P < .001). Conclusion: Internet-mediated physical activity interventions that focus on physical activity logging and goal setting while incorporating team competition may help a significant percentage of the target population maintain their physical activity during the winter months

Rationale, design and conduct of a randomised controlled trial evaluating a primary care-based complex intervention to improve the quality of life of heart failure patients: HICMan (Heidelberg Integrated Case Management) : study protocol

Background: Chronic congestive heart failure (CHF) is a complex disease with rising prevalence, compromised quality of life (QoL), unplanned hospital admissions, high mortality and therefore high burden of illness. The delivery of care for these patients has been criticized and new strategies addressing crucial domains of care have been shown to be effective on patients' health outcomes, although these trials were conducted in secondary care or in highly organised Health Maintenance Organisations. It remains unclear whether a comprehensive primary care-based case management for the treating general practitioner (GP) can improve patients' QoL. Methods/Design: HICMan is a randomised controlled trial with patients as the unit of randomisation. Aim is to evaluate a structured, standardized and comprehensive complex intervention for patients with CHF in a 12-months follow-up trial. Patients from intervention group receive specific patient leaflets and documentation booklets as well as regular monitoring and screening by a prior trained practice nurse, who gives feedback to the GP upon urgency. Monitoring and screening address aspects of disease-specific selfmanagement, (non)pharmacological adherence and psychosomatic and geriatric comorbidity. GPs are invited to provide a tailored structured counselling 4 times during the trial and receive an additional feedback on pharmacotherapy relevant to prognosis (data of baseline documentation). Patients from control group receive usual care by their GPs, who were introduced to guidelineoriented management and a tailored health counselling concept. Main outcome measurement for patients' QoL is the scale physical functioning of the SF-36 health questionnaire in a 12-month follow-up. Secondary outcomes are the disease specific QoL measured by the Kansas City Cardiomyopathy questionnaire (KCCQ), depression and anxiety disorders (PHQ-9, GAD-7), adherence (EHFScBS and SANA), quality of care measured by an adapted version of the Patient Chronic Illness Assessment of Care questionnaire (PACIC) and NTproBNP. In addition, comprehensive clinical data are collected about health status, comorbidity, medication and health care utilisation. Discussion: As the targeted patient group is mostly cared for and treated by GPs, a comprehensive primary care-based guideline implementation including somatic, psychosomatic and organisational aspects of the delivery of care (HICMAn) is a promising intervention applying proven strategies for optimal care. Trial registration: Current Controlled Trials ISRCTN30822978

The impact of disseminating the whole-community project '10,000 Steps': a RE-AIM analysis

<p>Abstract</p> <p>Background</p> <p>There are insufficient research reports on the wide-scale dissemination of effective whole-community physical activity (PA) programs. The purpose of this paper is to evaluate the impact of the wide-scale dissemination of '10,000 Steps', using the RE-AIM framework.</p> <p>Methods</p> <p>Dissemination efforts targeted a large region of Belgium and were concentrated on media strategies and peer networks of specific professional organizations, such as local health promotion services. Heads of department of 69 organizations received an on-line survey to assess project awareness, adoption, implementation and intended continuation of '10,000 Steps'. On the individual level, 755 citizens living in the work area of the organizations were interviewed for project awareness and PA levels. Measures were structured according to the RE-AIM dimensions (reach, effectiveness, adoption, implementation, maintenance). Independent sample <it>t </it>and chi-square tests were used to compare groups for representativeness at the organizational and individual level, and for individual PA differences.</p> <p>Results</p> <p>Of all organizations, 90% was aware of '10,000 Steps' (effectiveness - organizational level) and 36% adopted the project (adoption). The global implementation score was 52%. One third intended to continue the project in the future (maintenance) and 48% was still undecided. On the individual level, 35% of citizens were aware of '10,000 Steps' (reach). They reported significantly higher leisure-time PA levels than those not aware of '10,000 Steps' (256 ± 237 and 207 ± 216 min/week, respectively; <it>t </it>= -2.8; p < .005) (effectiveness - individual level). When considering representativeness, adoption of '10.000 Steps' was independent of most organizational characteristics, except for years of experience in PA promotion (7.6 ± 4.6 and 2.9 ± 5.9 years for project staff and non-project staff members, respectively; <it>t </it>= 2.79; <it>p </it>< 0.01). Project awareness in citizens was independent of all demographic characteristics.</p> <p>Conclusions</p> <p>'10,000 Steps' shows potential for wide-scale dissemination but a supportive linkage system seems recommended to encourage adoption levels and high quality implementation.</p

Evaluating the feasibility of a web-based weight loss programme for naval service personnel with excess body weight.

Overweight and obesity are a major concern that may influence the operational capacity of the UK Naval Service (NS). This study was conducted to evaluate the feasibility of trialling and implementing a modified web-based weight loss programme for overweight and obese NS personnel.Royal Navy; University of Southampto

Novel compound mutations in the mitochondrial translation elongation factor (TSFM) gene cause severe cardiomyopathy with myocardial fibro-adipose replacement

Primary mitochondrial dysfunction is an under-appreciated cause of cardiomyopathy, especially when cardiac symptoms are the unique or prevalent manifestation of disease. Here, we report an unusual presentation of mitochondrial cardiomyopathy, with dilated phenotype and pathologic evidence of biventricular fibro-adipose replacement, in a 33-year old woman who underwent cardiac transplant. Whole exome sequencing revealed two novel compound heterozygous variants in the TSFM gene, coding for the mitochondrial translation elongation factor EF-Ts. This protein participates in the elongation step of mitochondrial translation by binding and stabilizing the translation elongation factor Tu (EF-Tu). Bioinformatics analysis predicted a destabilization of the EF-Ts variants complex with EF-Tu, in agreement with the dramatic steady-state level reduction of both proteins in the clinically affected myocardium, which demonstrated a combined respiratory chain enzyme deficiency. In patient fibroblasts, the decrease of EF-Ts was paralleled by up-regulation of EF-Tu and induction of genes involved in mitochondrial biogenesis, along with increased expression of respiratory chain subunits and normal oxygen consumption rate. Our report extends the current picture of morphologic phenotypes associated with mitochondrial cardiomyopathies and confirms the heart as a main target of TSFM dysfunction. The compensatory response detected in patient fibroblasts might explain the tissue-specific expression of TSFM-associated disease

Evaluating the feasibility of a web-based weight loss programme for naval service personnel with excess body weight.

Overweight and obesity are a major concern that may influence the operational capacity of the UK Naval Service (NS). This study was conducted to evaluate the feasibility of trialling and implementing a modified web-based weight loss programme for overweight and obese NS personnel.Royal Navy; University of Southampto

Sustainability of the whole-community project '10,000 Steps': a longitudinal study

<p>Abstract</p> <p>Background</p> <p>In the dissemination and implementation literature, there is a dearth of information on the sustainability of community-wide physical activity (PA) programs in general and of the '10,000 Steps' project in particular. This paper reports a longitudinal evaluation of organizational and individual sustainability indicators of '10,000 Steps'.</p> <p>Methods</p> <p>Among project adopters, department heads of 24 public services were surveyed 1.5 years after initially reported project implementation to assess continuation, institutionalization, sustained implementation of intervention components, and adaptations. Barriers and facilitators of project sustainability were explored. Citizens (<it>n </it>= 483) living near the adopting organizations were interviewed to measure maintenance of PA differences between citizens aware and unaware of '10,000 Steps'. Independent-samples <it>t</it>, Mann-Whitney <it>U</it>, and chi-square tests were used to compare organizations for representativeness and individual PA differences.</p> <p>Results</p> <p>Of all organizations, 50% continued '10,000 Steps' (mostly in cycles) and continuation was independent of organizational characteristics. Level of intervention institutionalization was low to moderate on evaluations of routinization and moderate for project saturation. The global implementation score (58%) remained stable and three of nine project components were continued by less than half of organizations (posters, street signs and variants, personalized contact). Considerable independent adaptations of the project were reported (e.g. campaign image). Citizens aware of '10,000 Steps' remained more active during leisure time than those unaware (227 ± 235 and 176 ± 198 min/week, respectively; <it>t </it>= -2.6; p < .05), and reported more household-related (464 ± 397 and 389 ± 346 min/week, respectively; <it>t </it>= -2.2; p < .05) and moderate-intensity-PA (664 ± 424 and 586 ± 408 min/week, respectively; <it>t </it>= -2.0; p < .05). Facilitators of project sustainability included an organizational leader supporting the project, availability of funding or external support, and ready-for-use materials with ample room for adaptation. Barriers included insufficient synchronization between regional and community policy levels and preference for other PA projects.</p> <p>Conclusions</p> <p>'10,000 Steps' could remain sustainable but design, organizational, and contextual barriers need consideration. Sustainability of '10,000 Steps' in organizations can occur in cycles rather than in ongoing projects. Future research should compare sustainability other whole-community PA projects with '10,000 Steps' to contrast sustainability of alternative models of whole-community PA projects. This would allow optimization of project elements and methods to support decisions of choice for practitioners.</p