|- candidate number||9108|
|- NTR Number||NTR2764|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||14-feb-2011|
|- Secondary IDs||NL31235.068.10 / MEC 10-3-022 CCMO / METC Maastricht|
|- Public Title||Implementation of a nurse-led self-management support in primary care for type 2 diabetes patients with emotional distress with problems with daily functioning.|
|- Scientific Title||Nurse-led Self-Management Support (SMS) for emotional distress with problems with daily functioning: A pragmatic cluster randomised controlled trial among type 2 diabetes patients in primary care.|
|- Healt Condition(s) or Problem(s) studied||Diabetes Mellitus Type 2 (DM type II), Implementation, Primary care, Daily functioning, Emotional problems, Nurse practitioners, Minimal psychological intervention|
|- Inclusion criteria||Patients are eligible if they have a clinically established diagnosis of diabetes type II, are treated in primary care by a practice nurse, experience emotional distress and encounter problems with daily functioning.|
|- Exclusion criteria||Patients that are not able to read and write Dutch.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-aug-2011|
|- planned closingdate||1-aug-2013|
|- Target number of participants||460|
|- Interventions||PNs of the intervention arm will apply SMS in addition to usual care, i.e. 3-monthly diabetes check-ups according to the current guidelines. They will be trained during three 8-hours educational meetings to carry out SMS. The PNs learn to detect emotional distress and problems with daily functioning during regular consultations. Patients with severe problems will be referred to the GP. Patients with mild to moderate emotional problems (according to the 4DSQ) accompanied by problems with daily functioning (according to the Daily Functioning Thermometer) receive self management support from the PN in max. 2 extra consultations. The self-management support is based on principles of Problem Solving and/or Reattribution.
PNs of the control arm are instructed to provide usual care. They receive SMS training after follow-up.
|- Primary outcome||1. Daily functioning as measured by means of the Daily Functioning Thermometer (DFT), a visual analogue scale;|
2. Distress Scale of the 4DSQ to assess changes in distress symptoms.
|- Secondary outcome||1. Diabetes-related emotional distress (Problem Areas in Diabetes questionnaire);|
2. The presence and severity of other mental health problems (4DSQ);
3. Participation and autonomy (Impact on Participation and Autonomy questionnaire);
4. Quality of life, i.e. functional health and well-being from the patient’s point of view, (Short-Form Health Survey (SF-12));
5. Self-efficacy (General Self-Efficacy Scale, GSES-12);
6. Effect SMS on glycemic control (HbA1C);
7. The effect of SMS on diabetes care (two scales of the Patient Assessment of Chronic Illness Care, PACIC);
8. The effect of SMS on health care utilization refers to individual numbers of visits to the general practice, specialist referrals and admissions, mental health care visits, use of home care, and hours of paid and unpaid household help. Patients will record their health care use retrospectively (the last month).
|- Timepoints||T0: Baseline;|
T4: 4 months after baseline;
T12: A year after baseline.
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES|| A.N. Dijk, van - Vries, de|
|- CONTACT for SCIENTIFIC QUERIES|| A.N. Dijk, van - Vries, de|
|- Sponsor/Initiator ||CAPHRI, The Research Institute of the University Maastricht and University Hospital Maastricht (AZM)|
(Source(s) of Monetary or Material Support)
|CZ zorgverzekeringen, Diabetes Fonds, Stem van de Patient, Huisartsen Oostelijk Zuid Limburg , CAPHRI School for public health and primary care|
|- Publications||Van Dijk – de Vries A, Van Bokhoven MA, De Jong S, Metsemakers JFM, Verhaak PFM, Van der Weijden T Van Eijk JTM. Patients' readiness to receive psychosocial care during nurse-led routine diabetes consultations in primary care: A mixed methods study. International Journal of Nursing studies 2016; 63, 58-64. doi: http://dx.doi.org/10.1016/j.ijnurstu.2016.08.018
Van Dijk – de Vries, A. Het dagelijks functioneren centraal in een diabetesconsult. Implementatie van zelfmanagementondersteuning in de eerstelijns diabeteszorg. Verpleegkundige 2016; 2, 24-27.
Van Dijk – de Vries A, Van Bokhoven MA, Winkens B, Terluin B, Knottnerus JA, Van der Weijden T, Van Eijk JTM. Lessons learnt from a cluster-randomised trial evaluating the effectiveness of Self-Management Support (SMS) delivered by practice nurses in routine diabetes care. BMJ Open 2015; 5(6).
Van Dijk – de Vries A, Van Bokhoven M, Terluin B, Van der Weijden T Van Eijk JTM. Integrating nurse-led Self-Management Support (SMS) in routine primary care: design of a hybrid effectiveness-implementation study among type 2 diabetes patients with problems of daily functioning and emotional distress: a study protocol. BMC Fam Pract 2013; 14:77.
|- Brief summary||Emotional distress is prevalent among type 2 diabetes patients. It may lead to a downward spiral caused by poor adherence, deterioration of the condition and a further decline in daily functioning, which in turn aggravates the emotional problems. A nurse-led minimal psychological intervention for chronically ill appeared to be (cost) effective. For implementation in regular care, adaptations are needed. The adapted Self management Support (SMS) program facilitates practice nurses (PNs) to incorporate a stepped care approach of early detection and treatment of emotional distress accompanied by problems with daily functioning. A pragmatic cluster randomised controlled trial will be carried out with a baseline measurement and follow-ups after 4 and 12 months. The population consists of 46 practice nurses and their eligible diabetic patients (N=460; 10 per practice nurse). Practice nurses of the intervention group receive SMS training. They learn to detect emotional distress and problems with daily functioning, and to provide self management support to eligible patients. Patients with severe problems will be referred to the GP. The study involves an effect evaluation and process evaluation of SMS. Primary outcome measure is daily functioning. Secondary measures include emotional health status, participation and autonomy, control over the disease, self-efficacy, quality of life, patient reported assessment of care, and health care use. Process parameters measured by means of questionnaires and interviews explore the facilitators and barriers regarding successful implementation of SMS.|
|- Main changes (audit trail)|
|- RECORD||14-feb-2011 - 10-nov-2016|