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ComparEuEtdsWeb
QUESTION | |
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5. Should emotional-based behavioural techniques vs. usual care be used for adult patients living with obesity? | |
Population | adult patients living with obesity |
Intervention | Emotional-based behavioural techniques See more |
Comparison | Usual Care |
Main outcomes | Blood Pressure - Diastolic Blood Pressure; Blood pressure - Systolic Blood Pressure; Self-efficacy; Quality of life; Physical activity; Weight management - waist; Weight management- Weight; Weight management- BMI; Weight- Body fat; Depression; |
Setting | European Union, outpatient care |
Perspective | Clinical recommendation- Population perspective |
Background | Overweight and obesity are chronic metabolic diseases considered as a global public health problem, highly prevalent among adult population (i.e., ̴40%). Obesity increases the risk for many other diseases like diabetes, hypertension, and cancer, thus is a leading cause of disability and death. Some self-management interventions, as behavioural-based weight-loss interventions, have shown more weight loss than usual care and a decreased risk of developing diabetes. However, other health outcomes and long-term effects have been less well reported. Also, the association between weight loss and other health outcomes is still not clear. |
Conflict of interest |
This work was supported by the EU Horizon 2020 research and innovation programme (grant agreement no. 754936). The funder had no role in developing the protocol or obtaining the results for this study. |
ASSESSMENT | |||||||||||||||||||||||||
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Priority of problem Is the problem a priority? |
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JUDGEMENT | RESEARCH EVIDENCE | ||||||||||||||||||||||||
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Overweight and obesity are chronic metabolic diseases considered as a global public health problem, highly prevalent among adult population (i.e., ̴40%). Obesity increases the risk for many other diseases like diabetes, hypertension, and cancer, thus is a leading cause of disability and death. Some self-management interventions, as behavioural-based weight-loss interventions, have shown more weight loss than usual care and a decreased risk of developing diabetes. However, other health outcomes and long-term effects have been less well reported. Also, the association between weight loss and other health outcomes is still not clear. |
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Desirable Effects How substantial are the desirable anticipated effects? |
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JUDGEMENT | RESEARCH EVIDENCE | ||||||||||||||||||||||||
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View summary of findings of network meta-analysis
View summary of findings of component network meta-analysis |
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ADDITIONAL CONSIDERATIONS | |||||||||||||||||||||||||
The guideline panel has judged the desirable effects as small.
Important outcomes: Physical activity (SMD): 0.4346 SD higher(0.678 lower to 1.5475 higher)
Proportion of direct evidence contributing to the final NMA estimate per outcome: - DBP: 0% - SBP: 0% - BMI: 13% - Body fat: 0% - Waist size: 0% - Weight: 45% - QoL: 0% - Depression: 0% - Self-efficacy: 100%
Studies including the interventions: Rodriguez-Cristobal-2017 - Motivational intervention on top of standard programmed diet and exercise - 32 group/individual face-to-face sessions - Duration 24 months - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Eating behaviours § Doing physical activity
Ostbye-2015 - Educating about weight management strategies - 1 face-to-face session, 2 phone calls, internet-based contacts when needed; all individual - Duration 12 months - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Eating behaviours § Doing physical activity o Clinical management § Self-monitoring
Nurkkala-2015 - Lifestyle intervention consisting of a 9-month weight loss period followed by 27-month weight maintenance period - 14 individual face-to-face sessions - Duration 9 months - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Eating behaviours § Doing physical activity
Jospe-2017 - Diet and exercise advice in one face-to-face session (30-45 minutes) at baseline; monthly individual meetings where participants were weighed and could discuss ongoing successes and challenges - 13 individual face-to-face sessions - Duration 12 months - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Eating behaviours § Doing physical activity o Clinical management § Self-monitoring
Stapleton-2016 - Treatment of food cravings by emotional freedom techniques - 8 individual, weekly face-to-face sessions - Duration 8 weeks - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Eating behaviours o Psychological management § Handling/managing emotions
Borkoles-2016 - Self-determined, non-dieting lifestyle change program - 36 group/individual sessions - Duration 12 months - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Eating behaviours § Doing physical activity
Geiker-2016 - Dietetic counseling concerning both the diet and exercise - 8 individual face-to-face sessions - Duration 6 months - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Eating behaviours § Doing physical activity o Clinical management § Condition-specific behaviours § Self-monitoring
Leehey-2016 - 12-week program of aerobic and resistance training followed by 40 weeks of home exercise in diabetic patients with chronic kidney disease - 36 face-to-face sessions (3 per week), 40 weekly phone calls when needed; all individual - Duration 52 weeks - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Eating behaviours § Doing physical activity o Clinical management § Self-monitoring
Component Network Meta-analysis: DBP: the components with larger effect is education (E) SBP: the components with larger effect is education (E) Self-efficacy: the components with larger effects are education (E) and emotional-based behavioural techniques
Modeling estimations for long term consequences We used the COMPAR-EU model developed for the cost-effectiveness analysis to also inform about long-term health outcomes. Decision analysis models estimates provide valuable information for outcomes when empirical evidence is not available or is unfeasible (Trikalinos TA, 2009). The following events were estimated over a lifetime and informed by the effect of each SMIs over BMI from the NMA (see below). We suggest cautious interpretation as the certainty of the evidence for those input parameters was low to very low across comparisons. - Life-Years (LY): 85 days of additional life per person - Years with diabetes: 179 fewer days per person - Quality-Adjusted Life Years (QALY): 107 days of additional life equivalent to full health per person (undiscounted) - Diabetes mellitus: 19 fewer events per 1,000 persons - Myocardial infarction: 7 fewer events per 1,000 persons - Stroke: 8 fewer events per 1,000 persons |
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Undesirable Effects How substantial are the undesirable anticipated effects? |
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View summary of findings of network meta-analysis
There are no undesirable observed effects. |
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ADDITIONAL CONSIDERATIONS | |||||||||||||||||||||||||
The guideline panel judged the undesirable effects as trivial or no effect, or causing no harmful effects except for the potential associated burden of the intervention. |
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Certainty of the evidence What is the overall certainty of the evidence of effects? |
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Low/very low |
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ADDITIONAL CONSIDERATIONS | |||||||||||||||||||||||||
The guideline panel judged the certainty of evidence as very low |
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Values Is there important uncertainty about or variability in how much people value the main outcomes? |
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An overview of systematic reviews provided information about how patients value several of the outcomes of interest (critical/important) included in this clinical question:
Abbreviations: CI: confidence interval, EQ5D: EuroQol-5D a Utility values findings were assessed using the GRADE approach guidance (Zang 2019), and for findings assessing the burden for patients, we applied the CERQual approach (https://www.cerqual.org/) 1: Serious risk of indirectness (findings derived from a Japanese population) and imprecision (wide range of values reported). 2: Moderate concerns in the adequacy of findings (scarce and thin data) 3: Moderate concerns in relevance of findings, since these were reported in populations not participating in self-management interventions, they were collected based on general experiences with diabetes management. 4: Serious risk of indirectness regarding how the outcome was assessed, in studies of utility values, exploring the final state of having a specific BMI, and only some studies explored the weight change as BMI excess over 25, reporting it as the value per unit of excess. 5 Moderate concerns in the relevance of findings referred explicitly to adherence to medication (insulin and others) that can be integrated into SM treatment but were not collected from patients who explicitly participated in SM interventions. |
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ADDITIONAL CONSIDERATIONS | |||||||||||||||||||||||||
The guideline panel judged that there is probably no important uncertainty or variability of how patients value the main outcomes |
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Balance of effects Does the balance between desirable and undesirable effects favor the intervention or the comparison? |
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ADDITIONAL CONSIDERATIONS | |||||||||||||||||||||||||
The guideline panel judged that the balance of effects probably favorus the intervention. This is due to the desirable effects, the trivial undesirable effects, the lack of uncertainty and variability of how patients value outcomes, as well as the very low certainty of evidence of effects |
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Resources required How large are the resource requirements (costs)? |
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Estimated costs for the intervention across all types of self-management interventions (SMIs), as described in the included studies of the network meta-analysis were on average 438 euros, with a range from 11 to 1565 euros.
Incremental health costs (without the intervention) was 682 euros. Note: This average/range estimate has been based on 13 cost estimates of SMI for obesity reported in publications |
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ADDITIONAL CONSIDERATIONS | |||||||||||||||||||||||||
The guideline panel considered that the resources required for this intervention varies. We could not provide cost for any specific type of SMI intervention. Instead the cost described is the average across all the SMIs assessed in the overall network meta-analysis Costing data for SMIs should be interpreted with caution. We used the data collected from the included studies on the number of sessions, duration of sessions, group size, and primary person performing the intervention to estimate the labor cost of providing the intervention. In many instances, detailed information was missing in the available literature (for example the average group size or duration of sessions). In those cases, we assumed an average of what was reported within a comparison. Some costs were omitted such as information on booklets and other training materials, Therefore, these estimates provide uncertain evidence of the potential cost for any given intervention.
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Certainty of evidence of required resources What is the certainty of the evidence of resource requirements (costs)? |
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ADDITIONAL CONSIDERATIONS | |||||||||||||||||||||||||
The guideline panel has agreed on a very low certainty of the evidence on this domain |
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Cost-effectiveness Does the cost-effectiveness of the intervention favor the intervention or the comparison? |
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Estimated costs for the intervention across all types of self-management interventions (SMIs), as described in the included studies of the network meta-analysis were on average 438 euros, with a range from 11 to 1565 euros.
NA: non applicable; QALY: quality adjusted life years; ICER: incremental cost-effectiveness ratio Explanations The cost-effectiveness results are for the UK setting. For more information on the cost-effectiveness analysis and the results for other countries, please see the cost-effectiveness section. The ICER calculation is based on total costs and QALY estimations from the cost-effectiveness analyses. While total cost in the cost-effectiveness analyses exclude intervention costs, a minimum and maximum intervention cost was estimated based on literature and added to the total costs to estimate the ICER. As such, the ICERs indicate the potential range of cost per QALY including intervention cost. |
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ADDITIONAL CONSIDERATIONS | |||||||||||||||||||||||||
The guideline panel judged that these SMIs may be cost-effective, in particular when the range of cost estimates is in the same range as the headroom estimates. Overall interpretation should be that there is a possibility that these SMIs are cost-effective, in particular because the average cost of SMI for obesity in the literature (438 euro: range 11-1565 euro) is lower than the headroom estimate (see the explanation of headroom analysis). Given the uncertainty in the cost estimates, it is important to be very cautious when comparing the ICERs (incremental cost-effectiveness ratio) for specific SMIs to the headroom to determine the most efficient intervention. |
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Equity What would be the impact on health equity? |
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ADDITIONAL CONSIDERATIONS | |||||||||||||||||||||||||
The panel agreed that if implemented tailored to culture and health literacy it could increase equity.
Equity might be affected by geography and accessibility. |
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Acceptability Is the intervention acceptable to key stakeholders? |
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JUDGEMENT | RESEARCH EVIDENCE | ||||||||||||||||||||||||
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The information below has been obtained through an overview of systematic reviews of contextual factors, as well as a scoping review and one overview of systematic reviews of values and preferences. It also includes considerations from a Delphi study that was conducted in COMPAR-EU that included the most important contextual factors for the implementation of components (e.g. groups, peers) of self-management interventions according to stakeholders.
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ADDITIONAL CONSIDERATIONS | |||||||||||||||||||||||||
The guideline panel judged that this type of SMI is probably acceptable to key stakeholders.
Patients/caregivers: overall acceptable but may vary since it could be influenced by setting, accessibility, tailoring, and other factors.
Studies' Interventions Leehey-2016 - 12-week program of aerobic and resistance training followed by 40 weeks of home exercise in diabetic patients with chronic kidney disease - 36 face-to-face sessions (3 per week), 40 weekly phone calls when needed; all individual - Duration 52 weeks - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Eating behaviours § Doing physical activity o Clinical management § Self-monitoring
Geiker-2016 - Dietetic counseling concerning both the diet and exercise - 8 individual face-to-face sessions - Duration 6 months - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Eating behaviours § Doing physical activity o Clinical management § Condition-specific behaviours § Self-monitoring
Borkoles-2016 - Self-determined, non-dieting lifestyle change program - 36 group/individual sessions - Duration 12 months - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Eating behaviours § Doing physical activity
Nurkkala-2015 - Lifestyle intervention consisting of a 9-month weight loss period followed by 27-month weight maintenance period - 14 individual face-to-face sessions - Duration 9 months - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Eating behaviours § Doing physical activity
Ostbye-2015 - Educating about weight management strategies - 1 face-to-face session, 2 phone calls, internet-based contacts when needed; all individual - Duration 12 months - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Eating behaviours § Doing physical activity o Clinical management § Self-monitoring
Usually, duration of follow-up was not provided in the studies.
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Feasibility Is the intervention feasible to implement? |
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JUDGEMENT | RESEARCH EVIDENCE | ||||||||||||||||||||||||
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The information below has been obtained through an overview of systematic reviews of contextual factors, as well as a scoping review and one overview of systematic reviews of values and preferences. It also includes considerations from a Delphi study that was conducted in COMPAR-EU that included the most important contextual factors for the implementation of components (e.g. groups,peers) of self-management interventions according to stakeholders.
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ADDITIONAL CONSIDERATIONS | |||||||||||||||||||||||||
The guideline panel judged that this type of SMI is probably feasible. Limited human resources may complicate the implementation of this SMI.
Studies' Interventions Rodriguez-Cristobal-2017 - Motivational intervention on top of standard programmed diet and exercise - 32 group/individual face-to-face sessions - Duration 24 months - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Eating behaviours § Doing physical activity
Stapleton-2016 - Treatment of food cravings by emotional freedom techniques - 8 individual, weekly face-to-face sessions - Duration 8 weeks - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Eating behaviours o Psychological management § Handling/managing emotions
Borkoles-2016 - Self-determined, non-dieting lifestyle change program - 36 group/individual sessions - Duration 12 months - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Eating behaviours § Doing physical activity Nurkkala-2015 - Lifestyle intervention consisting of a 9-month weight loss period followed by 27-month weight maintenance period - 14 individual face-to-face sessions - Duration 9 months - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Eating behaviours § Doing physical activity
Jospe-2017 - Diet and exercise advice in one face-to-face session (30-45 minutes) at baseline; monthly individual meetings where participants were weighed and could discuss ongoing successes and challenges - 13 individual face-to-face sessions - Duration 12 months - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Eating behaviours § Doing physical activity o Clinical management § Self-monitoring
Geiker-2016 - Dietetic counseling concerning both the diet and exercise - 8 individual face-to-face sessions - Duration 6 months - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Eating behaviours § Doing physical activity o Clinical management § Condition-specific behaviours § Self-monitoring
Ostbye-2015 - Educating about weight management strategies - 1 face-to-face session, 2 phone calls, internet-based contacts when needed; all individual - Duration 12 months - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Eating behaviours § Doing physical activity o Clinical management § Self-monitoring
Leehey-2016 - 12-week program of aerobic and resistance training followed by 40 weeks of home exercise in diabetic patients with chronic kidney disease - 36 face-to-face sessions (3 per week), 40 weekly phone calls when needed; all individual - Duration 52 weeks - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Eating behaviours § Doing physical activity o Clinical management § Self-monitoring Usually, duration of follow-up was not provided in the studies.
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TYPE OF RECOMMENDATION | ||||
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Strong recommendation against the intervention | Conditional recommendation against the intervention | Conditional recommendation for either the intervention or the comparison | Conditional recommendation for the intervention | Strong recommendation for the intervention |
CONCLUSIONS |
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Recommendation |
In patients with Obesity, the COMPAR-EU Obesity panel, suggests in favour of the use of emotional-based behavioural techniques (coaching, motivation and stress management), rather than usual care (conditional, very low certainty of the evidence about the effects) |
Justification |
The COMPAR-EU Obesity panel made a conditional recommendation in favour of emotional-based behavioural techniques (coaching, motivation and stress management), rather than usual care alone, due to a probably favourable balance of effects and cost-effectiveness that probably favours the intervention. |
Subgroup considerations |
Implementation considerations |
When implementing SMI in general, the most important contextual factors to keep in mind are:
When implementing Emotional-based behavioural techniques, the most important contextual factors to keep in mind are:
When implementing Education the most important contextual factors to keep in mind are:
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Monitoring and evaluation |
Research priorities |
- Future studies should measure patient important outcomes, both critical and important (list below), have adequate sample size and follow-up, including after the intervention is finished. - Future studies should address also preferences and values of patients in relation to their self management, cost effectiveness and sub-categories of self-monitoring interventions. - Future studies should describe in detail the aspects of the intervention and evalute the long term effectiveness. - Future studies should addresss practical outcomes for patients with obesity, for example, levels of cortisol, inflammation markers and include psychological needs of the patients. - Future studies should address patient's related costs.
Critical outcomes Self-Efficacy Eating self-efficacy Exercise self-efficacy ((Physical activity; Steps per day) Qol (Stress; Depression) Blood pressure (SBP; DBP) Long term complications Weight management (BMI; waist; weight; body fat)
Important outcomes Patient activation Self-monitoring (dietary; weight) Adherence (to medication; to programme) Comorbidities (diabetes) Dietary habits (Dietary habits; Fat consumption, fibre consumption; carbohydrates; fruit and vegetable; consumption of fat) Coping with the disease |
REFERENCES SUMMARY |
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Summary of findings of network meta-analysis
COMPAR-EU iSoF Web
Summary of findings of component network meta-analysis
COMPONENT NETWORK META-ANALYSIS (sensitivity analysis)
| Components's effect (95% Confidence Interval) | CNMA effect (95% Confidence Interval) | |
Outcome | E | EB | |
DBP | 0,0858 (-1,2254 to 1,397) | 1,0322 (0,238 to 1,8263) | 0,4524 (-0,8163 to 1,721) |
SBP | -1,0057 (-3,1051 to 1,0938) | 0,8721 (-0,3708 to 2,115) | -0,9607 (-2,9271 to 1,0057) |
SE | 0,8434 (0,3176 to 1,3693) | 0,2965 (-0,1989 to 0,7919) | 0,7699 (0,1605 to 1,3792) |
Components' definition:
E: Education; EB: Emotional - based behavioural change techniques
Components
Education (E)
Education (E)
Sharing information. This form of support consists in sharing of information about self-management topics like coping with symptoms, diet, exercise, medication, information about what other people are doing, and information about the disease itself, or about any other relevant aspects that could lead to improved self-management, and ultimately better health. This information can be told or distributed in printed materials like a folder or workbook, or via website or DVD.
Examples: Educational session on healthy eating for people with obesity, provision of a printed leaflet on the importance of foot care in diabetes, or a link to a website with information on chronic obstructive pulmonary disease care.
Emotional-based change techniques (EB)
Emotional-based change techniques (EB)
There are different emotional-based behavioural change techniques:
Stress and/or emotional management. This technique consists in helping you to understand the role of stress and emotions and teaching them to use different coping strategies to manage, for example, stress and painful emotions caused by your disease.
Examples: Mindfulness, exercise, stretching, listening to music, deep breathing, or meditation.
Coaching and motivational interviewing. This kind of support helps you to change behaviours by looking what’s important to you, and then offering support, taking into account your needs and preferences. One provider (healthcare professional, peer or lay person) is usually your coach. Motivational interviewing and counselling are included, as well as collaborative conversations with a practitioner, helping with motivation and commitment, minimizing resistance, and resolve ambivalence to change.
Examples: coaching sessions led by a nurse to ease the transition from hospital to home, or rehabilitation programs using coaching methods.
Individual sessions
A single person receives the self-management support. Examples: self-guided actions (without the participation of any other person) during a clinical visit or within the context of a support or educational session
Face-to-face
Self-management support delivered in a face-to-face encounter between the providers and patients and/or caregivers.