No registrations found.
ID
Source
Brief title
Health condition
emotional distress / emotionele klachten
implementation / implementatie
type 2 diabetes mellitus
primary care / eerstelijnszorg
practice nurse / praktijkondersteuner
minimal psychological intervention / minimale psychologische interventie
daily functioning / dagelijks functioneren
Sponsors and support
Zorgverzekeraar CZ
Huisartsen Oostelijk Zuid Limburg
CAPHRI School for public health and primary care
Intervention
Outcome measures
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).
Background 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.
Study design
T0: Baseline;
T4: 4 months after baseline;
T12: A year after baseline.
Intervention
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.
A.N. Dijk, van - Vries, de
P. Debeyeplein 1
Maastricht 6200 MD
The Netherlands
+31 (0)43 3882315
anneke.vandijk@maastrichtuniversity.nl
A.N. Dijk, van - Vries, de
P. Debeyeplein 1
Maastricht 6200 MD
The Netherlands
+31 (0)43 3882315
anneke.vandijk@maastrichtuniversity.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2636 |
| NTR-old | NTR2764 |
| CCMO | NL31235.068.10 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON34709 |
Summary results
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Van Dijk – de Vries, A. Het dagelijks functioneren centraal in een diabetesconsult. Implementatie van zelfmanagementondersteuning in de eerstelijns diabeteszorg. Verpleegkundige 2016; 2, 24-27.
<br><br>
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).
<br><br>
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.