Guided Self-Determination Research Articles

Detailed statistical analysis plan for a guided self-determination intervention versus an attention control for outpatients with type 2 diabetes in the randomised OVERCOME trial

BackgroundAutonomy-supporting interventions may be a prerequisite to achieve better long-term management of type 2 diabetes. Evidence suggests that the guided self-determination (GSD) method might improve haemoglobin A1c and diabetes distress in people with type 1 diabetes. The evidence of an effect of a GSD intervention compared with an attention control group in adults with type 2 diabetes is unknown.Methods/designThe trial is designed as a pragmatic, investigator-initiated, dual-centre, randomised, parallel-group, assessor-blinded, superiority clinical trial of persons with type 2 diabetes. A nurse will administer GSD intervention versus an attention control. The primary outcome is diabetes distress, and secondary outcomes are quality of life, depressive symptoms, and non-serious adverse events. Exploratory outcomes are haemoglobin A1c, motivation, and serious adverse events. Participants are assessed at baseline, 5-, and 12-month follow-up. Here, we present a detailed, comprehensive plan of all statistical analyses, including methods to handle missing data, and assessments of the underlying statistical assumptions. The statistical analyses will be conducted independently by two statisticians following the present plan.DiscussionTo mitigate the risk of analysis bias and increase the validity of the OVEROME trial, this statistical analysis plan was developed prior to unblinding of the trial results in concordance with the Declaration of Helsinki and the Conference on Harmonization of Good Clinical Practice Guidelines.Trial registrationClinicalTrials.gov NCT 04601311. Registered on October 2020.

Scratching the Surface—Person-Centered Knowledge Morally and Professionally Commits Nurses: An Interview Study

BackgroundRegardless of the tight schedule in outpatient settings caring should be based on patients believes of what is important in relation to maintain everyday life. Guided self-determination (GSD) is a method that supports reflection, collaboration, decision-making, and problem-solving. PurposeThe purpose was to examine clinical nurses’ and ward managers experience of GSD during radiation or outpatient chemotherapy treatment. MethodA qualitative interview study using a phenomenological hermeneutic approach was used. FindingsTwo overall themes were generated “GSD is meaningful to both clinical nurses, ward managers, and patients” and “GSD creates an extraordinary room for counseling incompatible with clinical practice in a short-term contact but causing moral distress”. ConclusionAll nurses experienced the GSD intervention to be meaningful but difficult to implement in a busy technical field. This created a dilemma in everyday clinical practice with the risk of causing moral distress. The nurses used different strategies to cope with this.

Feasibility and acceptability of an online guided self-determination program to improve diabetes self-management in young adults.

Evaluate the feasibility and acceptability of an online guided self-determination (GSD) program to improve diabetes self-management skills among young adults with type 1 diabetes (YAD). An online program comprising seven structured interactive conversations was designed. A pre- and post- interventional study used a sequential, two-phase multiple method design. Phase one comprised a training program for diabetes educators (DEs). In Phase two YAD participated in program and completed pre- and post-surveys assessing motivation to self-manage, perceived competence in diabetes and communication with DEs. Both YAD and DEs provided a program evaluation. The online GSD program was acceptable, feasible and effective in improving autonomous motivation in self-management and communication with DEs. Easy access and program flexibility were highly appreciated by both participant groups and perceived to assist YAD to stay motivated. The program had a significant impact on the diabetes self-management of YAD and was a feasible and acceptable way to engage and communicate with DEs. The GSD platform contributes to age appropriate and person-centred diabetes self-management. It can potentially reach geographically distanced populations, or with social circumstances or other barriers impeding in-person service provision.

Guided self-determination intervention versus attention control for people with type 2 diabetes in outpatient clinics: a protocol for a randomised clinical trial

IntroductionIn the management of type 2 diabetes, autonomy-supporting interventions may be a prerequisite to achieving more long-term improvement. Preliminary evidence has shown that the guided self-determination (GSD) method might have...

Guided self-determination in treatment of chronic pain- a randomized, controlled trial.

To test whether Guided Self-Determination (GSD) used in chronic pain management could improve the health-related quality of life, patient activation and sense of coherence (SoC) as a measurement of life skills in patients with chronic pain. The method has been shown to be effective in other chronic conditions, but has not been tested in chronic pain. A three-site randomised, controlled trial at three major multidisciplinary pain centres in Denmark. 200 patients were included and randomised. In the intervention period, both groups had regular visits to the pain centre with both doctors and nurses. The intervention group additionally received the GSD intervention with weekly sessions for eight weeks. Data were collected from February 2013 to July 2016 and consisted of three questionnaires answered before and after the 8-week intervention period, and after six months. The primary outcome was self-reported health related quality of life. Secondary outcomes included self-reported activation and SoC. We found no clinically relevant difference between the groups for health-related quality of life, patient activation or SoC at either baseline, at three months or at six months. We also analysed data for trends over time using mixed model analysis, and this did not show any significant differences between groups. GSD did not improve health-related quality of life, patient activation or SoC when administered to patients with chronic pain treated in a multidisciplinary pain centre. New research is recommended using a combination of self-reported and objective measures and longer follow-up.

The patient's agenda: nurses’ experience of learning and using guided self‐determination

Health care has seen a shift towards person-centred care to encompass the entirety of a person's needs and preferences, but research is sparse on healthcare professionals learning and using person-centred care. To investigate nurses' experiences of learning and using the person-centred method guided self-determination (GSD) in three different gynaecological settings and to determine whether, and potentially, how new tasks introduced by the GSD method influence their professional identity. A qualitative interview study conducted between January 2019 and January 2020. We conducted 16 semi-structured interviews with nurses educated in using GSD. Applying inductive and deductive reasoning, we analysed the interviews using thematic analysis. The study was registered with the Danish Data Protection Agency (file no.: VD-2018-445, I-Suite no.: 6700). The analysis generated three main themes with two subthemes each: (a) prerequisites and barriers to learning and using GSD in terms of personal factors and organisational and method-related factors; (b) new knowledge and understanding of illness with the subthemes expanded understanding of illness and a different relationship; and (c) nursing undergoing change with the subthemes, a new role and a professional self shaped through interaction with other professions. Although other professionals may have either supported or challenged the use of GSD, most nurses indicated that it supplemented their professional role and identity as they gained new knowledge about person-centred challenges and felt more confident. When introducing GSD in nursing, the organisation must not only consider individual characteristics, multidisciplinary collaboration and communication but also plan individual education and supervision. This is necessary because all these factors affect how a new professional role is constructed and adopted, not to mention how it influences the nurses' perception of their professional identity and use of GSD. Establishing a helpful person-centred environment must also be considered.

Written reflection in an eHealth intervention for adults with type 2 diabetes mellitus: a qualitative study.

BackgroundIndividuals with type 2 diabetes mellitus (T2DM) are responsible for the daily decisions and actions necessary to manage their disease, which makes self-management the cornerstone of diabetes care. Many patients do not reach recommended treatment goals, and thus it is important to develop and evaluate innovative interventions that facilitate optimal motivation for adequate self-management of T2DM.ObjectiveThe aim of the current study was to explore how adults with T2DM experience using reflection sheets to stimulate written reflection in the context of the Guided Self-Determination (GSD) eHealth intervention and how written reflection might affect their motivation for self-management of T2DM.MethodsWe used a qualitative design in which data were collected through individual interviews. The sample consisted of 10 patients who completed the GSD eHealth intervention, and data were analyzed using qualitative content analysis.ResultsThe qualitative content analysis yielded 2 main themes. We labeled the first theme as “Written reflection affects awareness and commitment in diabetes self-management”, which reflects 2 subthemes, namely, “Writing creates space and time for autonomous reflection” and “Writing influences individuals’ focus in diabetes self-management”. We labeled the second theme as “Written reflection is perceived as inapplicable in diabetes self-management”, which reflects 2 subthemes, namely, “Responding in writing is difficult” and “The timing of the writing is inappropriate”.ConclusionOur findings indicate that written reflection in the context of the GSD eHealth intervention may be conducive to motivation for diabetes self-management for some patients. However, it seems that in-person consultation with the diabetes nurse may be necessary to achieve the full potential benefit of the GSD as an eHealth intervention. We advocate further development and examination of the GSD as a “blended” approach, especially for those who consider written reflection to be difficult or unfamiliar.

Guided self-determination-young versus standard care in the treatment of young females with type 1 diabetes: study protocol for a multicentre randomized controlled trial

BackgroundFemale adolescents with type 1 diabetes mellitus (T1DM) have the most unsatisfactory glycaemic control of all age groups and report higher disease burden, poorer perceived health, and lower quality of life than their male counterparts. Females with T1DM face an excess risk of all-cause mortality compared with men with T1DM. New methods are needed to help and support young females with T1DM to manage their disease.A prerequisite for successful diabetes management is to offer individualized, person-centred care and support the patient’s own motivation. Guided self-determination (GSD) is a person-centred reflection and problem-solving method intended to support the patient’s own motivation in the daily care of her diabetes and help develop skills to manage difficulties in diabetes self-management. GSD has been shown to improve glycaemic control and decrease psychosocial stress in young women with T1DM. The method has been adapted for adolescents and their parents, termed GSD-young (GSD-Y). The aim of this study was to evaluate whether an intervention with GSD-Y in female adolescents with T1DM leads to improved glycaemic control, self-management, treatment satisfaction, perceived health and quality of life, fewer diabetes-related family conflicts, and improved psychosocial self-efficacy.Methods/designThis is a parallel-group randomized controlled superiority trial with an allocation ratio of 1:1. One hundred female adolescents with T1DM, 15–20 years of age, and their parents (if < 18 years of age), will be included. The intervention group will receive seven individual GSD-Y education visits over 3 to 6 months. The control group will receive standard care including regular visits to the diabetes clinic. The primary outcome is level of glycaemic control, measured as glycosylated haemoglobin (HbA1c). Secondary outcomes include diabetes self-management, treatment satisfaction, perceived health and quality of life, diabetes-related family conflicts, and psychosocial self-efficacy. Data will be collected before randomization and at 6 and 12 months.DiscussionPoor glycaemic control is common in female adolescents and young adults with T1DM. Long-standing hyperglycaemia increases the risks for severe complications and may also have an adverse impact on the outcome of future pregnancies. In this study, we want to evaluate if the GSD-Y method can be a useful tool in the treatment of female adolescents with T1DM.Trial registrationCurrent controlled trials, ISRCTN57528404. Registered on 18 February 2015.

The effect of guided self-determination on self-management in persons with type 1 diabetes mellitus and HbA1c ≥64 mmol/mol: a group-based randomised controlled trial

ObjectivesTo determine whether the impact of guided self-determination (GSD) applied in group training (GSD-GT) in people with chronically elevated HbA1c and type 1 diabetes mellitus (DM) was superior to ‘care...

Dropout From an eHealth Intervention for Adults With Type 2 Diabetes: A Qualitative Study.

BackgroundAdequate self-management is the cornerstone of type 2 diabetes treatment, as people make the majority of daily treatment measures and health decisions. The increasing prevalence of type 2 diabetes mellitus (T2DM) and the complexity of diabetes self-management demonstrate the need for innovative and effective ways to deliver self-management support. eHealth interventions are promoted worldwide and hold a great potential in future health care for people with chronic diseases such as T2DM. However, many eHealth interventions face high dropout rates. This led to our interest in the experiences of participants who dropped out of an eHealth intervention for adults with T2DM, based on the Guided Self-Determination (GSD) counseling method.ObjectiveIn this study, we aimed to explore experiences with an eHealth intervention based on GSD in general practice from the perspective of those who dropped out and to understand their reasons for dropping out. To the best of our knowledge, no previous qualitative study has focused on participants who withdrew from an eHealth self-management support intervention for adults with T2DM.MethodsA qualitative design based on telephone interviews was used to collect data. The sample comprised 12 adults with type 2 diabetes who dropped out of an eHealth intervention. Data were collected in 2016 and subjected to qualitative content analysis.ResultsWe identified one overall theme: “Losing motivation for intervention participation.” This theme was illustrated by four categories related to the participants’ experiences of the eHealth intervention: (1) frustrating technology, (2) perceiving the content as irrelevant and incomprehensible, (3) choosing other activities and perspectives, and (4) lacking face-to-face encounters.ConclusionsOur findings indicate that the eHealth intervention based on GSD without face-to-face encounters with nurses reduced participants’ motivation for engagement in the intervention. To maintain motivation, our study points to the importance of combining eHealth with regular face-to-face consultations. Our study also shows that the perceived benefit of the GSD eHealth intervention intertwined with choosing to focus on other matters in complex daily lives are critical aspects in motivation for such interventions. This indicates the importance of giving potential participants tailored information about the aim, the content, and the effort needed to remain engaged in complex interventions so that eligible participants are recruited. Finally, motivation for engagement in the eHealth intervention was influenced by the technology used in this study. It seems important to facilitate more user-friendly but high-security eHealth technology. Our findings have implications for improving the eHealth intervention and to inform researchers and health care providers who are organizing eHealth interventions focusing on self-management support in order to reduce dropout rates.

SA133. That is What We Already Do! Mental Health Care Professionals’ Responses to Working With an Evidence-Based Intervention Supporting Patient Involvement

Background: In the recent decades, patient involvement, shared decision-making, and recovery have become important factors in interventions in mental health care and treatment. The Guided Self-Determination (GSD) method is consistent with these demands and has been tested in an open randomized controlled trial and proved to reduce negative symptoms and emotional discomfort in patients diagnosed with schizophrenia. Research has until now focused on effectiveness of the GSD method and patients’ experiences; however, no research within mental health has focused on mental health-care professionals’ (MHCP) experiences of working with the GSD method. Level of acceptability of a new intervention is just as important from an MHCP’s perspective as from a patient’s perspective, especially in the implementation process is this knowledge valuable. The aim of this study was to investigate MHCPs’ responses to working with the GSD method in the care of inpatients with severe mental illness. Methods: This qualitative study was part of a mixed methods study with an explanatory sequential design. The setting was four psychiatric wards, 1 forensic and 3 open adult wards for patients with psychotic disorders. Semistructured qualitative interviews were conducted with 9 MHCPs. Also, field notes were generated from participating observation of the MHCPs weekly/biweekly supervision of utilizing the GSD method. The analysis of the qualitative data was guided by thematic analysis by Braun & Clarke. Results: The analysis is currently being conducted and the main findings will be presented at the poster. Conclusion: The conclusion will be presented at the poster.

Assessment of a web-based Guided Self-Determination intervention for adults with type 2 diabetes in general practice: a study protocol

IntroductionSelf-management is deemed the cornerstone in overall diabetes management. Web-based self-management interventions have potential to support adults with type 2 diabetes (T2DM) in managing their disease. Owing to somewhat ambiguous...

DEVELOPING LIFE SKILLS IN HAEMODIALYSIS USING THE GUIDED SELF‐DETERMINATION METHOD: A QUALITATIVE STUDY

Studies in patients with diabetes have shown that the guided self determination (GSD) method effectively improves patients' glycaemia control and life skills. As a pilot study in 2011 showed promising results of using parts of GSD adjusted to patients on haemodialysis (HD), we decided to develop and test a full-scale GSD for this patient group (GSD-HD). To study how a full-scale GSD-HD influenced the quality of relatedness between the patient and the GSD-HD nurse and the patients' ability to live well with end stage renal disease (ESRD). GSD-HD was developed through participatory research and evaluated qualitatively at five dialysis units in Denmark involving 31 patients and 16 nurses. The intervention lasted four months and comprised six sessions. Data consisting of semi-structured interviews with 13 patients were analysed using a mix of inductive and deductive thematic analysis. A process of developing life skills was clearly identified in the changes accomplished by all 13 participants going through the GSD-HD intervention. Six themes showed that the changes involved the patients personally, their relationships with healthcare professionals and relatives and their self-management of ESRD: Deeper and more meaningful relationships, self-exploration of self-selected challenges, self-understanding as a condition for meaningful knowledge, ability to act in a self-determined way, feedback from action that accords with daily life skills and decision-making from professional to share. The positive changes identified in this qualitative evaluation are promising and indicate that GSD-HD has a potential worthwhile to be tested further among patients with ESRD.

The psychosocial needs of gynaecological cancer survivors: A framework for the development of a complex intervention

PurposeTo develop and pilot test an intervention targeting the women's psychosocial needs during the follow-up period after surgical treatment for gynaecological cancer. MethodsThe project consisted of four phases. Phase 1 involved development of an intervention on the basis of meetings with key healthcare professionals, a literature review and six semi-structured interviews with women who attended the existing follow-up program. The Guided Self-Determination (GSD) method developed in diabetes care was identified as an appropriate framework for the intervention. GSD consists of reflection sheets for patients and advanced professional communication skills. The GSD method was adapted to women in a follow-up program after gynaecologic cancer treatment (GSD-GYN-C). Phase 2 involved primary pilot testing of the intervention and the findings were used to modify the intervention in phase 3. This modification involved the development of additional reflection sheets and a fidelity assessment tool. A systematic training program was arranged for the GSD-GYN-C-nurses. Phase 4 involved secondary pilot testing where nurses and women confirmed the applicability of GSD-GYN-C and final adjustments were made. Selected measurements were tested for sensitivity during pilot testing. Data from phase 2 and 4 were also used to select the primary outcome and calculate power for a future randomized clinical trial (RCT). ResultsPilot testing supported our hypothesis that GSD-GYN-C may be transferable and useful to survivors of gynaecological cancer. ConclusionGSD-GYN-C was developed and validated and is now ready for evaluation in an RCT.

Effects on cognitive and clinical insight with the use of Guided Self-Determination in outpatients with schizophrenia: A randomized open trial

Poor insight has a negative impact on the outcome in schizophrenia; consequently, poor insight is a logical target for treatment. However, neither medication nor psychosocial interventions have been demonstrated to improve poor insight. A method originally designed for diabetes patients to improve their illness management, Guided Self-Determination (GSD), has been adapted for use in patients with schizophrenia (GSD-SZ). The purpose of this study was to investigate the effect on insight of GSD-SZ as a supplement to treatment as usual (TAU) as compared to TAU alone in outpatients diagnosed with schizophrenia. The design was an open randomized trial. The primary hypothesis was cognitive insight would improve in those patients who received GSD-SZ+TAU as assessed by the BCIS. We additionally explored whether the intervention led to changes in clinical insight, self-perceived recovery, self-esteem, social functioning and symptom severity. Assessments were conducted at baseline, and at 3-, 6- and 12-month follow-up. Analysis was based on the principles of intention to treat and potential confounders were taken into account through applying a multivariate approach. A total of 101 participants were randomized to GSD-SZ+TAU (n=50) or to TAU alone (n=51). No statistically significant differences were found on the cognitive insight. However, at 12-month follow-up, clinical insight (measured by G12 from the Positive and Negative Syndrome Scale), symptom severity, and social functioning had statistically significantly improved in the intervention group as compared to the control group. “Improving insight in patients diagnosed with schizophrenia”, NCT01282307, http://clinicaltrials.gov/.

Effect of guided self-determination youth intervention integrated into outpatient visits versus treatment as usual on glycemic control and life skills: a randomized clinical trial in adolescents with type 1 diabetes.

BackgroundProviding care for adolescents with type 1 diabetes is complex, demanding, and often unsuccessful. Guided self-determination (GSD) is a life skills approach that has been proven effective in caring for adults with type 1 diabetes. To improve care, GSD was revised for adolescents, their parents, and interdisciplinary healthcare providers (HCP) to create GSD-Youth (GSD-Y). We evaluated the impact of GSD-Y after it was integrated into pediatric outpatient visits versus treatment-as-usual, focusing on glycemic control and the development of life skills in adolescents with type 1 diabetes.MethodsSeventy-one adolescents (mean age: 15 years, mean duration of diabetes: 5.7 years, mean HbA1c: 77 mmol/mol (9.1%), upon entering the study) from two pediatric departments were randomized into a GSD-Y group (n = 37, GSD-Y was provided during individual outpatient sessions) versus a treatment-as-usual group (n = 34). The primary outcome was the HbA1c measurement. The secondary outcomes were life skills development (assessed by self-reported psychometric scales), self-monitored blood glucose levels, and hypo- and hyperglycemic episodes. The analysis followed an intention-to-treat basis.ResultsFifty-seven adolescents (80%) completed the trial, and 53 (75%) completed a six-month post-treatment follow-up. No significant effect of GSD-Y on the HbA1c could be detected in a mixed-model analysis after adjusting for the baseline HbA1c levels and the identity of the HCP (P = 0.85). GSD-Y significantly reduced the amotivation for diabetes self-management after adjusting for the baseline value (P = 0.001). Compared with the control group, the trial completion was prolonged in the GSD-Y group (P <0.001), requiring more visits (P = 0.05) with a higher rate of non-attendance (P = 0.01). GSD-Y parents participated in fewer of the adolescents’ visits (P = 0.05) compared with control parents.ConclusionsCompared with treatment-as-usual, GSD-Y did not improve HbA1c levels, but it did decrease adolescents’ amotivation for diabetes self-management.Trial registrationISRCTN 54243636, registered on 10 January 2010. Life skills for adolescents with type 1 diabetes and their parents.

Experiences of Nurses as They Introduce the Guided Self-Determination (GSD) Counselling Approach in Outpatient Nurse Consultations among People with Type 1 Diabetes

Aim:The aim of this study was to gain insight into how nurses experience the introduction of a new empowerment-based approach, Guided Self-Determination (GSD), in outpatient nurse-led group consultations among adults with type 1 diabetes.Background:Participation in group education programmes is essential to provide people with diabetes with necessary knowledge and skills to self-manage their condition. However, research is lacking on the experiences of nurses introducing new teaching methods and approaches in diabetes management.Methods:We collected data from qualitative interviews with five nurses employed at a university hospital in Norway. The interviews were taped and transcribed. We performed the analysis according to the Braun & Clarke description of thematic analysis and followed their six phases.Findings:The process the nurses went through could be a challenge. Leaving their usual practice “on safe ground”, they went through three stages: “in open waters”, “weather the storms” and “help to navigat...

Overcoming recruitment barriers revealed high readiness to participate and low dropout rate among people with schizophrenia in a randomized controlled trial testing the effect of a Guided Self-Determination intervention

BackgroundRecruitment is one of the most serious challenges in performing randomized controlled trials. Often clinical trials with participants diagnosed with schizophrenia are terminated prematurely because of recruitment challenges resulting in a considerable waste of resources in the form of time, funding, and the participants’ efforts. Dropout rates in schizophrenia trials are also high.Recruitment challenges are often due to patients not wanting to participate in research but can also be due to clinicians’ concerns regarding individuals diagnosed with schizophrenia as participants in research. This paper reports how overcoming recruitment challenges not related to patients revealed high readiness to take part and low dropout rates in a one year long randomized controlled trial testing Guided Self-Determination (GSD) among outpatients with schizophrenia receiving treatment in Assertive Outreach Teams in the northern part of Denmark.MethodsGSD is a shared decision-making and mutual problem-solving method using reflection sheets, which was developed in diabetes care and adjusted for this study and utilized by patients with schizophrenia. Descriptive data on strategies to overcome recruitment challenges were derived from notes and observations made during the randomized controlled trial testing of GSD in six outpatient teams.ResultsThree types of recruitment challenges not related to patients were identified and met during the trial: 1) organizational challenges, 2) challenges with finding eligible participants and 3) challenges with having professionals invite patients to participate. These challenges were overcome through: 1) extension of time, 2) expansion of the clinical recruitment area and 3) encouragement of professionals to invite patients to the study. Through overcoming these challenges, we identified a remarkably high patient-readiness to take part (101 of 120 asked accepted) and a low dropout rate (8%).ConclusionDistinction between recruitment challenges was important in discovering the readiness among patients with schizophrenia to take part in and complete a trial with the GSD-intervention.

A multicentre randomized controlled trial of an empowerment-inspired intervention for adolescents starting continuous subcutaneous insulin infusion - a study protocol

BackgroundContinuous subcutaneous insulin infusion (CSII) treatment among children with type 1 diabetes is increasing in Sweden. However, studies evaluating glycaemic control in children using CSII show inconsistent results. The distribution of responsibility for diabetes self-management between children and parents is often unclear and needs clarification. There is much published support for continued parental involvement and shared diabetes management during adolescence. Guided Self-Determination (GSD) is an empowerment-based, person-centred, reflection and problem solving method intended to guide the patient to become self-sufficient and develop life skills for managing difficulties in diabetes self-management. This method has been adapted for adolescents and parents as Guided Self-Determination-Young (GSD-Y). This study aims to evaluate the effect of an intervention with GSD-Y in groups of adolescents starting on insulin pumps and their parents on diabetes-related family conflicts, perceived health and quality of life (QoL), and metabolic control. Here, we describe the protocol and plans for study enrolment.Methods/designThis study is designed as a randomized, controlled, prospective, multicentre study. Eighty patients between 12–18 years of age who are planning to start CSII will be included. All adolescents and their parents will receive standard insulin pump training. The education intervention will be conducted when CSII is to be started and at four appointments in the first 4 months after starting CSII. The primary outcome is haemoglobin A1c levels. Secondary outcomes are perceived health and QoL, frequency of blood glucose self-monitoring and bolus doses, and usage of carbohydrate counting. The following instruments will be used: Disabkids, ‘Check your health’, the Diabetes Family Conflict Scale and the Swedish Diabetes Empowerment Scale. Outcomes will be evaluated within and between groups by comparing data at baseline, and at 6 and 12 months after starting treatment.DiscussionIn this study, we will assess the effect of starting an CSII together with the model of GSD to determine whether this approach leads to retention of improved glycaemic control, QoL, responsibility distribution and reduced diabetes-related conflicts in the family.Trial registrationCurrent controlled trials: ISRCTN22444034

Promoting psychosocial well-being following a stroke: Developing a theoretically and empirically sound complex intervention

BackgroundThe psychosocial consequences of stroke are complex and comprehensive and include substantial and longlasting impacts on mood, identity, social relationships, return to work and quality of life. Many studies have explored possible interventions to prevent or treat psychosocial problems, but the results have generally been disappointing. Very few studies have provided adequate theoretical accounts of the mechanisms assumed to contribute to positive outcomes. ObjectivesTo describe the development of a psychosocial nursing intervention aimed at promoting psychosocial health and well-being and to stimulate dialogue about how to develop and report theoretically and empirically sound complex interventions in nursing. DesignA systematic, stepwise approach was used, consistent with the framework recommended for developing and evaluating complex interventions by the UK Medical Research Council. Data sourcesSystematic reviews of empirical studies regarding the psychosocial consequences and needs of patients following stroke; qualitative, experiential studies of stroke and stroke recovery; theories of psychosocial well-being, coping, life skills, narrative approaches to rehabilitation and guided self-determination. Review methodsEach systematic review was examined to determine the major psychosocial challenges and needs experienced by stroke survivors, focusing on how these challenges and needs developed over the illness trajectory, how previous interventions had sought to address them and the effective mechanisms assumed to affect the level of success of interventions. Qualitative studies were examined to reveal the subjective experiences of stroke and stroke recovery, paying particular attention to the development of needs across time and context. A qualitative synthesis of the major characteristics of the trajectory of stroke rehabilitation and recovery during the first year was developed. Theories were examined to illuminate possible effective mechanisms and actions aimed at promoting psychosocial well-being during the stroke recovery process. ResultsA dialogue-based intervention comprising eight encounters between stroke survivors and trained health care workers was designed, based on narrative theories, empowerment philosophy and guided self determination. Worksheets and a guiding topical outline were developed to support the dialogue. ConclusionsThe UK Medical Research Council framework facilitated the systematic development of an empirically and theoretically informed complex nursing intervention aimed at promoting post-stroke psychosocial well-being.