Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
BMC Primary Care
Published in: BMC Primary Care 1/2013

Open Access 01-12-2013 | Study protocol

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

Authors: Anneke van Dijk - de Vries, Marloes A van Bokhoven, Berend Terluin, Trudy van der Weijden, Jacques Th M van Eijk

Published in: BMC Primary Care | Issue 1/2013

Login to get access

Abstract

Background

Psychosocial problems are more prevalent among patients with chronic diseases than among the general population. They may lead to a downward spiral of poor adherence, deterioration of the condition and decline in daily functioning. In addition to medical management, systematic attention to emotional and role management tasks during routine chronic care seems mandatory. We intend to integrate an existing nurse-led minimal psychological intervention to support patients’ self-management, which appeared to be effective and cost-effective, in routine care by primary care nurses, so we adjusted it to fit the host setting. The resulting Self-Management Support (SMS) programme involves early detection of patients with emotional distress and problems of daily functioning, as well as self-management support through problem solving and reattribution techniques. Strategies to embed SMS in daily practice include training and booster sessions for practice nurses as well as organisational and financial arrangements. This study aims to simultaneously evaluate the implementation process and effects of SMS in routine care, using a hybrid effectiveness–implementation design.

Methods/Design

Registration data, questionnaires and interviews will be used to explore the facilitators, barriers and costs regarding successful implementation of SMS. The effects of SMS will be evaluated in a pragmatic cluster-randomised controlled trial with a baseline measurement and follow-up measurements after 4 and 12 months. The population will consist of 46 practice nurses and their type 2 diabetes patients (N = 460; 10 per practice nurse). The practice nurses will be randomly assigned to the intervention or control group. Practice nurses of the intervention group will receive SMS training. Patients for the intervention and control groups will be recruited by a researcher-led self-administered screening procedure to decide which patients of those scheduled for routine consultation are likely to be detected by the practice nurses as eligible for the self-management support. Primary outcome measure is patients’ daily functioning. Secondary measures include emotional well-being, participation, autonomy and control over the disease.

Discussion

Our hybrid study design is complicated by the detection method used by the practice nurses. This method is an implementation issue in itself that has consequences for the realisation and power of the effect evaluation.

Trial registration

Current Controlled Trials, NTR2764
Appendix
Available only for authorised users
Literature
1.
Härter M, Baumeister H, Reuter K, Jacobi F, Höfler M, Bengel J, Wittchen H-U: Increased 12-month prevalence rates of mental disorders in patients with chronic somatic diseases. Psychother Psychosom. 2007, 76: 354-360. 10.1159/000107563.CrossRefPubMed
2.
Ali S, Stone MA, Peters JL, Davies MJ, Khunti K: The prevalence of co-morbid depression in adults with type 2 diabetes: a systematic review and meta-analysis. Diabet Med. 2006, 23 (11): 1165-1173. 10.1111/j.1464-5491.2006.01943.x.CrossRefPubMed
3.
Van den Bemt L, Schermer T, Bor H, Smink R, Van Weel-Baumgarten E, Lucassen P, Van Weel C: The risk for depression comorbidity in patients with COPD. Chest. 2009, 135 (1): 108-114. 10.1378/chest.08-0965.CrossRefPubMed
4.
Pouwer F: Should we screen for emotional distress in type 2 diabetes mellitus?. Nat Rev Endocrinol. 2009, 5 (12): 665-671. 10.1038/nrendo.2009.214.CrossRefPubMed
5.
Jerant A, Kravitz R, Moore-Hill M, Franks P: Depressive symptoms moderated the effect of chronic illness self-management training on self-efficacy. Med Care. 2008, 46 (5): 523-531. 10.1097/MLR.0b013e31815f53a4.CrossRefPubMed
6.
Fisher L, Mullan JT, Arean P, Glasgow RE, Hessler D, Masharani U: Diabetes distress but not clinical depression or depressive symptoms is associated with glycemic control in both cross-sectional and longitudinal analyses. Diabet Care. 2010, 33 (1): 23-28. 10.2337/dc09-1238.CrossRef
7.
DiMatteo MR, Lepper HS, Croghan TW: Depression is a risk factor for noncompliance with medical treatment: meta-analysis of the effects of anxiety and depression on patient adherence. Arch Int Med. 2000, 160 (14): 2101-2107. 10.1001/archinte.160.14.2101.CrossRef
8.
Lorig KR, Holman H: Self-management education: history, definition, outcomes, and mechanisms. Ann Behav Med. 2003, 26 (1): 1-7.CrossRefPubMed
9.
Netherlands Diabetes Federation: NDF care standard. Transparancy and quality of diabetes care for people with type 2 diabetes. 2007, Amersfoort: Nederlandse Diabetes Federatie (NDF)
10.
Rutten GEHM, De Grauw WJC, Nijpels G, Goudswaard AN, Uitewaal PJM, Van der Does FEE, Heine RJ, Van Ballegooie E, Verduijn MM, Bouma M: NHG-standaard diabetes mellitus type 2 (tweede herziening) [NHG practice guideline diabetes mellitus type 2 (second revision)]. Huisarts Wet. 2006, 49 (3): 137-152.
11.
Van Eijk JTM, Bosma H, Jonkers CC, Lamers F, Muijrers EM: Prescribing antidepressants and benzodiazepines in the Netherlands: is chronic physical illness involved?. Depress Res Treat. 2010, 2010 (Article ID 105931): 6-10.1155/2010/105931.
12.
Van Weel-Baumgarten E, Lucassen P, Hassink-Franke L, Schers H: A different way of looking at depression. Int J Clin Pract. 2010, 64 (11): 1493-1495. 10.1111/j.1742-1241.2010.02405.x.CrossRefPubMed
13.
Van Dijk-de VA, Moser A, Mertens VC, van der Linden J, van der Weijden T, van Eijk JT: The ideal of biopsychosocial chronic care: How to make it real? A qualitative study among Dutch stakeholders. BMC Fam Pract. 2012, 13 (1): 14-10.1186/1471-2296-13-14.CrossRef
14.
Moser A, van der Bruggen H, Widdershoven G, Spreeuwenberg C: Self-management of type 2 diabetes mellitus: a qualitative investigation from the perspective of participants in a nurse-led, shared-care programme in the Netherlands. BMC Public Health. 2008, 8 (1): 91-10.1186/1471-2458-8-91.CrossRefPubMedPubMedCentral
15.
Jonkers C, Lamers F, Bosma H, Metsemakers J, Kempen G, Van Eijk J: Process evaluation of a minimal psychological intervention to reduce depression in chronically ill elderly persons. Patient Educ Couns. 2007, 68 (3): 252-257. 10.1016/j.pec.2007.06.010.CrossRefPubMed
16.
Jonkers CCM, Lamers F, Evers SMAA, Bosma H, Metsemakers JFM, van Eijk JTM: Economic evaluation of a minimal psychological intervention in chronically ill elderly patients with minor or mild to moderate depression: a randomised trial (the DELTA study). Int J Technol Assess Health Care. 2009, 25 (4): 497-504. 10.1017/S026646230999050X.CrossRefPubMed
17.
Lamers F, Jonkers CCM, Bosma H, Kempen GIJM, Meijer JAMJ, Penninx BWJH, Knottnerus JA, van Eijk JTM: A minimal psychological intervention in chronically ill elderly patients with depression: a randomised trial. Psychother Psychosom. 2010, 79 (4): 217-226. 10.1159/000313690.CrossRefPubMed
18.
Lamers F, Jonkers CCM, Bosma H, Knottnerus JA, van Eijk JTM: Treating depression in diabetes patients: does a minimal psychological intervention affect diabetes-specific quality of life and glycemic control? A randomized controlled trial. J Adv Nur. 2011, 67 (4): 788-799. 10.1111/j.1365-2648.2010.05540.x.CrossRef
19.
Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C: Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012, 50 (3): 217-226. 10.1097/MLR.0b013e3182408812.CrossRefPubMedPubMedCentral
20.
Lamers F, Jonkers CCM, Bosma H, Diederiks JPM, van Eijk JTM: Effectiveness and cost-effectiveness of a minimal psychological intervention to reduce non-severe depression in chronically ill elderly patients: the design of a randomised controlled trial. BMC Public Health. 2006, 6 (1): 161-10.1186/1471-2458-6-161.CrossRefPubMedPubMedCentral
21.
Durlak J, DuPre E: Implementation matters: a review of research on the influence of implementation on program outcomes and the factors affecting implementation. Am J Community Psychol. 2008, 41 (3): 327-350.CrossRefPubMed
22.
Braam C, van Oostrom SH, Terluin B, Vasse R, De Vet HCW, Anema JR: Validation study of a distress screener. J Occup Rehabil. 2009, 19 (3): 231-237. 10.1007/s10926-009-9178-z.CrossRefPubMedPubMedCentral
23.
Terluin B, van Marwijk HWJ, Ader HJ, de Vet HCW, Penninx BWJH, Hermens MLM, van Boeijen CA, van Balkom AJLM, van der Klink JJL, Stalman WAB: The four-dimensional symptom questionnaire (4DSQ): a validation study of a multidimensional self-report questionnaire to assess distress, depression, anxiety and somatization. BMC Psychiatry. 2006, 6: 34-10.1186/1471-244X-6-34.CrossRefPubMedPubMedCentral
24.
Van Eijk JTM, Diederiks JPM, Kempen GIJM, Honig A, Van der Meer K, Brenninkmeijer WJM: Development and feasibility of a nurse administered strategy on depression in community-dwelling patients with a chronic physical disease. Patient Educ Couns. 2004, 54 (1): 87-94. 10.1016/S0738-3991(03)00201-5.CrossRefPubMed
25.
Mynors-Wallis L: Problem solving treatment in general psychiatric practice. Advan Psychiatr Treat. 2001, 7: 417-425. 10.1192/apt.7.6.417.CrossRef
26.
De Hollander A, Hoeymans N, Melse J, Van Oers J, Polder J: Zorg voor gezondheid - Volksgezondheid Toekomst Verkenning 2006 [Public Health Forecast 2006]. 2006, Houten: Bohn Stafleu Van Loghum
27.
De Jong A, Van Duin C: Regionale prognose 2009–2040: vergrijzing en omslag in groei naar krimp [Local forecast 2009–2040: ageing and demographic change from growth to shrinkage]. Bevolkingstrends. 2009, 57 (4): 35-44.
28.
Penninx BW, Beekman ATF, Ormel J, Kriegsman DM, Boeke AJP, Van Eijk JTM, Deeg DJH: Psychological Status among elderly people with chronic disease: does type of disease play a part?. J Psychosom Res. 1996, 40: 521-534. 10.1016/0022-3999(95)00620-6.CrossRefPubMed
29.
Tsiachristas A, Hipple-Walters B, Lemmens KMM, Nieboer AP, Rutten-van Mölken MPMH: Towards integrated care for chronic conditions: Dutch policy developments to overcome the (financial) barriers. Health Poli. 2010, 101 (2): 122-132.CrossRef
30.
Hulscher M, Laurant M, Grol R: Process evaluation of change interventions. Improving patient care the implementation of change in clinical practice. Edited by: Grol R, Wensing M, Eccles M. 2005, Oxford: Elsevier Butterwork Heineman, 256-272.
31.
Saunders RP, Evans MH, Joshi P: Developing a process-evaluation plan for assessing health promotion program implementation: a How-to guide. Health Promot Pract. 2005, 6 (2): 134-147. 10.1177/1524839904273387.CrossRefPubMed
32.
Fade S: Using interpretative phenomenological analysis for public health nutrition and dietetic research: a practical guide. Proc Nutr Soc. 2004, 63 (4): 647-653. 10.1079/PNS2004398.CrossRefPubMed
33.
Campbell MK, Fayers PM, Grimshaw JM: Determinants of the intracluster correlation coefficient in cluster randomized trials: the case of implementation research. Clin Trials. 2005, 2 (2): 99-107. 10.1191/1740774505cn071oa.CrossRefPubMed
34.
Tuinman MA, Gazendam-Donofrio SM, Hoekstra-Weebers JE: Screening and referral for psychosocial distress in oncologic practice. Cancer. 2008, 113 (4): 870-878. 10.1002/cncr.23622.CrossRefPubMed
35.
Polonsky WH, Anderson BJ, Lohrer PA, Welch GW, Jacobson AM, Aponte JE, Schwartz CE: Assessment of diabetes-related distress. Diabet Care. 1995, 18: 754-760. 10.2337/diacare.18.6.754.CrossRef
36.
Snoek FJ, Pouwer F, Welch GW, Polonsky WH: Diabetes-related emotional distress in Dutch and U.S. diabetic patients: cross-cultural validity of the problem areas in diabetes scale. Diabet Care. 2000, 23 (9): 1305-1309. 10.2337/diacare.23.9.1305.CrossRef
37.
Welch G, Weinger K, Anderson B, Polonsky WH: Responsiveness of the problem areas in diabetes (PAID) questionnaire. Diabet Med. 2003, 20 (1): 69-72. 10.1046/j.1464-5491.2003.00832.x.CrossRefPubMed
38.
Ashworth M, Robinson S, Godfrey E, Stepherd M, Evans C, Seed P, Parmentier H, Tylee A: Measuring mental health outcomes in primary care: the psychometric properties of a new patient-generated outcome measure, ‘PSYCHLOPS’ (‘psychological outcome profiles’). Primary Care Mental Health. 2005, 3 (4): 261-270.
39.
Aaronson NK, Muller M, Cohen PD, Essink-Bot ML, Fekkes M, Sanderman R, Sprangers MA, te Velde A, Verrips E: Translation, validation, and norming of the Dutch language version of the SF-36 Health Survey in community and chronic disease populations. J Clin Epidemiol. 1998, 51 (11): 1055-1068. 10.1016/S0895-4356(98)00097-3.CrossRefPubMed
40.
Ware JE, Kosinski M, Keller S: A 12-item short-form health survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996, 34 (3): 220-233. 10.1097/00005650-199603000-00003.CrossRefPubMed
41.
Cardol M, De Haan RJ, De Jong BA, van den Bos GA, De Groot IJ: Psychometric properties of the impact on participation and autonomy questionnaire. Arch Phys Med Rehabil. 2001, 82 (2): 210-216. 10.1053/apmr.2001.18218.CrossRefPubMed
42.
43.
Hakkaart-van Roijen L, Bouwmans C: Manual Short Form-Health and Labour Questionnaire (SF-HLQ). 2007, Rotterdam, theNetherlands: Erasmus Universitair Medisch Centrum Rotterdam, Institute for Medical Technology Assessment
44.
Petkov J, Harvey P, Battersby M: The internal consistency and construct validity of the partners in health scale: validation of a patient rated chronic condition self-management measure. Qual Life Res. 2010, 19 (7): 1079-1085. 10.1007/s11136-010-9661-1.CrossRefPubMed
45.
Bosscher RJ, Smit JH: Confirmatory factor analysis of the general self-efficacy scale. Behav Res Ther. 1998, 36 (3): 339-343. 10.1016/S0005-7967(98)00025-4.CrossRefPubMed
46.
Sherer M, Maddux JE, Mercadante B, Prentice-Dunn S, Jacobs B, Rogers RW: The self-efficacy scale: construction and validation.Psychol Rep. 1982, 51 (2): 663-671. 10.2466/pr0.1982.51.2.663.CrossRef
47.
Cully JA, Armento ME, Mott J, Nadorff MR, Naik AD, Stanley MA, Sorocco KH, Kunik ME, Petersen NJ, Kauth MR: Brief cognitive behavioral therapy in primary care: a hybrid type 2 patient-randomized effectiveness implementation design. Implement Sci. 2012, 7 (1): 64-10.1186/1748-5908-7-64.CrossRefPubMedPubMedCentral
Metadata
Title
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
Authors
Anneke van Dijk - de Vries
Marloes A van Bokhoven
Berend Terluin
Trudy van der Weijden
Jacques Th M van Eijk
Publication date
01-12-2013
Publisher
BioMed Central
Published in
BMC Primary Care / Issue 1/2013
Electronic ISSN: 2731-4553
DOI
https://doi.org/10.1186/1471-2296-14-77

Other articles of this Issue 1/2013

BMC Primary Care 1/2013 Go to the issue

Research article

Family physician enabling attitudes: a qualitative study of patient perceptions

Research article

Which patient and treatment factors are related to successful cardiovascular risk score reduction in general practice? Results from a randomized controlled trial

Research article

Primary care patient willingness for genetic testing for salt-sensitive hypertension: a cross sectional study

Study protocol

Prescribing ANtiDepressants Appropriately (PANDA): a cluster randomized controlled trial in primary care

Research article

Preventive care in general practice among healthy older New South Wales residents

Research article

Family physicians’ diagnostic gut feelings are measurable: construct validation of a questionnaire