Living with diabetes: a group-based self-management support programme for T2DM patients in the early phases of illness and their partners, study protocol of a randomised controlled trial

BMC Health Services Research

François G Schellevis³  Guy EHM Rutten¹  Giel Nijpels³  Monique JWM Heijmans²  Mieke Rijken²  Anne L van Puffelen² 

[1] Julius Center for Health Sciences and Primary Care, UMC Utrecht, Utrecht, The Netherlands;NIVEL, Netherlands Institute for Health Services Research, PO Box 1568, 3500 BN Utrecht, The Netherlands;Department of General Practice & Elderly Care Medicine, EMGO Institute for Health and Care Research, VU University Medical Center, Amsterdam, The Netherlands

关键词: Health-related quality of life;    Self-management;    Partner support;    Illness perceptions;    Randomised controlled trial;    Diabetes;   

Others  :  1133028
DOI  :  10.1186/1472-6963-14-144

 received in 2013-10-16, accepted in 2014-02-26,  发布年份 2014

【 摘 要 】

Background

The present article presents the protocol for a randomised controlled trial to test the effectiveness of a group-based self-management support programme for recently diagnosed type 2 diabetes mellitus (T2DM) patients (one to three years post-diagnosis) and their partners. The course aims to support T2DM patients and their partners in successfully integrating diabetes care into their daily lives and hereby enhance self-management and diabetes-specific health-related quality of life. The content of the course is based on the Common-Sense Model of Self-Regulation (CSM). Furthermore, principles from the Social Cognitive Theory (SCT) and social support theories are integrated.

Methods/Design

We aim to recruit 160 recently diagnosed T2DM patients and their partners from general practices in six different regions in the Netherlands. Patients need to be diagnosed with T2DM for one to three years and have to experience some degree of diabetes-related difficulties, as measured with a three-item screener. Participating patients and their partners are randomly allocated to the intervention or control condition. Participants in the intervention condition receive three monthly group sessions and a booster session three months later. Participants in the control condition receive a single information meeting. Data will be collected at baseline (T0), directly after the programme (T1) and six months post-programme (T2), including: self-management, diabetes-specific health-related quality of life, illness perceptions, attitudes, social support and empowerment. A three-level multilevel model will be used to compare change-scores between the conditions (intervention/control) on each outcome.

Discussion

Our study will be the first to determine whether a group-based support programme based on the CSM is effective in enhancing self-management and diabetes-specific health-related quality of life in recently diagnosed T2DM patients. The important role of patients’ partners in effective diabetes care is also acknowledged in the study.

Trial registration

Netherlands National Trial Register (NTR) NTR3302.

【 授权许可】

   
2014 van Puffelen et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 4.

Figure 2.

【 参考文献 】

• [1]International Diabetes F: The IDF Diabetes Atlas. Fifth Edition. Brussels: International Diabetes Federation; 2012.
• [2]Solli O, Stavem K, Kristiansen IS: Health-related quality of life in diabetes: the associations of complications with EQ-5D scores. Health Qual Life Outcomes 2010, 8:18. BioMed Central Full Text
• [3]Kovacs BK, Nicolucci A, Holt RIG, Willaing I, Hermanns N, Kalra S, Wens J, Pouwer F, Skovlund SE, Peyrot M, the DAWN2 Study Group: Diabetes Attitudes, Wishes and Needs second study (DAWN2): cross-national benchmarking indicators for family members living with people with diabetes. Diabet Med 2013, 30:778-788.
• [4]American Diabetes A: Economic costs of diabetes in the U.S. In 2012. Diabetes Care 2013, 36:1033-1046.
• [5]King P, Peacock I, Donnelly R: The UK prospective diabetes study (UKPDS): clinical and therapeutic implications for type 2 diabetes. Br J Clin Pharmacol 1999, 48:643-648.
• [6]UK Prospective Diabetes Study Group: Quality of life in type 2 diabetic patients is affected by complications but not by intensive policies to improve blood glucose or blood pressure control (UKPDS 37). U.K. Prospective Diabetes Study Group. Diabetes Care 1999, 22:1125-1136.
• [7]Rubin RR, Peyrot M: Quality of life and diabetes. Diabetes Metab Res Rev 1999, 15:205-218.
• [8]Gray A, Raikou M, McGuire A, Fenn P, Stevens R, Cull C, Stratton I, Adler A, Holman R, Turner R, he United Kingdom Prospective Diabetes Study Group: Cost effectiveness of an intensive blood glucose control policy in patients with type 2 diabetes: economic analysis alongside randomised controlled trial (UKPDS 41). United Kingdom Prospective Diabetes Study Group. BMJ 2000, 320:1373-1378.
• [9]Glasgow RE, Eakin EG: Issues in Diabetes Self-Management. In The Handbook of Behaviour Change. Edited by Shumaker SA, Schron EB, Ockene JK, McBee WL. New York: Springer Publishing Company; 1998:435-461.
• [10]Ahola AJ, Groop PH: Barriers to self-management of diabetes. Diabet Med 2013, 30:413-420.
• [11]Steed L, Cooke D, Newman S: A systematic review of psychosocial outcomes following education, self-management and psychological interventions in diabetes mellitus. Patient Educ Couns 2003, 51:5-15.
• [12]Whittemore R: Behavioral interventions for diabetes self-management. Nurs Clin North Am 2006, 41:641-654.
• [13]Harvey JN, Lawson VL: The importance of health belief models in determining self-care behaviour in diabetes. Diabet Med 2009, 26:5-13.
• [14]Thoolen B, de Ridder D, Bensing J, Gorter K, Rutten G: No worries, no impact? A systematic review of emotional, cognitive and behavioral responses to the diagnosis of type 2 diabetes. Health Psychol Rev 2008, 2:65-93.
• [15]Cameron LD, Leventhal H: The Self-Regulation of Health and Illness Behavior. London: Routlegde; 2003.
• [16]Leventhal H, Meyer D, Nerenz DR: The Common-Sense Representation of Illness Danger. In Contributions to Medical Psychology. Edited by Rachman S. New York: Pergamon Press; 1980:17-30.
• [17]Leventhal H, Nerenz DR, Steele DJ: Illness Representations and Coping with Health Threats. In Handbook of Psychology and Health. Edited by Baum A, Taylor SE, Singer JE. Hillsdale NJ: Erlbaum; 1984:219-252.
• [18]Hagger MS, Orbell S: A meta-analytic review of the common-sense model of illness representations. Psychol Health 2003, 18:141-184.
• [19]Petrie KJ, Cameron LD, Ellis CJ, Buick D, Weinman J: Changing illness perceptions after myocardial infarction: an early intervention randomized controlled trial. Psychosom Med 2002, 64:580-586.
• [20]Moss-Morris R, Humphrey K, Johnson MH, Petrie KJ: Patients’ perceptions of their pain condition across a multidisciplinary pain management program: do they change and if so does it matter? Clin J Pain 2007, 23:558-564.
• [21]Keogh KM, Smith SM, White P, McGilloway S, Kelly A, Gibney J, O'Dowd T: Psychological family intervention for poorly controlled type 2 diabetes. Am J Manag Care 2011, 17:105-113.
• [22]Searle A, Norman P, Thompson R, Vedhara K: Illness representations among patients with type 2 diabetes and their partners: relationships with self-management behaviors. J Psychosom Res 2007, 63:175-184.
• [23]van Dam HA, van der Horst FG, Knoops L, Ryckman RM, Crebolder HF, van den Borne BH: Social support in diabetes: a systematic review of controlled intervention studies. Patient Educ Couns 2005, 59:1-12.
• [24]Figueiras MJ, Weinman J: Do similar patients and spouse perceptions of myocardial infarction predict recovery? Psychol Health 2003, 18:201-216.
• [25]Heijmans M, De Ridder DTD, Bensing J: Dissimilarity in patients’ and spouses’ representations of chronic illness: exploration of relations to patient adaptation. Psychol Health 1999, 14:451-466.
• [26]Snoek FJ, Hogenelst MH: Psychological implications of diabetes mellitus. Ned Tijdschr Geneeskd 2008, 152:2395-2399.
• [27]Carey MP, Jorgensen RS, Weinstock RS, Sprafkin RP, Lantinga LJ, Carnrike CL Jr, Baker MT, Meisler AW: Reliability and validity of the appraisal of diabetes scale. J Behav Med 1991, 14:43-51.
• [28]Moss-Morris R, Weinman J, Petrie KJ, Horne R, Cameron LD, Buick D: The Revised Illness Perceptions Questionnaire (IPQ-R). Psychol Health 2002, 17:1-16.
• [29]Bandura A: Self-efficacy: towards a unifying theory of behavioral change. Psychol Rev 1977, 84:191-215.
• [30]Bandura A: Social Foundations of Thought and Action: A Social Cognitive Theory. Englewood Cliffs, NJ: Prentice-Hall; 1986.
• [31]Thoits PA: Social Support and Psychological Well-Being: theoretical Possibilities. In Social Support: Theory, Research and Applications. Dordrecht, the Netherlands: Martinus Nijhoff; 1985:51-72.
• [32]Lazarus RS, Folkman S: Stress, Appraisal and Coping. New York: Springer; 1984.
• [33]Schwarzer R, Leppin A, Social support and health: A theoretical and empirical overview. J Soc Pers Relat 1991, 8:99-127.
• [34]Keogh KM, White P, Smith SM, McGilloway S, O’Dowd T, Gibney J: Changing illness perceptions in patients with poorly controlled type 2 diabetes, a randomised controlled trial of a family-based intervention: protocol and pilot study. BMC Fam Pract 2007, 8:36. BioMed Central Full Text
• [35]Toobert DJ, Hampson SE, Glasgow RE: The summary of diabetes self-care activities measure: results from 7 studies and a revised scale. Diabetes Care 2000, 23:943-950.
• [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. Diabetes Care 2000, 23:1305-1309.
• [37]Welch GW, Jacobson AM, Polonsky WH: The problem areas in diabetes scale. An evaluation of its clinical utility. Diabetes Care 1997, 20:760-766.
• [38]Welch GW, Weiniger K, Anderson B, Polonsky WH: Responsiveness of the Problem Areas in Diabetes (PAID) questionnaire. Diabet Med 2003, 20:69-72.
• [39]Anderson RM, Fitzgerald JT, Funnell MM, Gruppen LD: The third version of the diabetes attitude scale. Diabetes Care 1998, 21:1403-1407.
• [40]Buunk BP, Berkhuysen MA, Sanderman RA, Nieuwland W, Ranchor AV: Actieve betrokkenheid, beschermend bufferen en overbescherming (Active engagement, protective buffering and overprotection). Gedrag en Gezondheid 1996, 24:304-313.
• [41]Buysse H, De Moor G, Coorevits P, Van Maele G, Kaufman J, Ruige J: Main characteristics of type 1 and type 2 diabetes patients interested in the use of the telemonitoring platform. J Nurs Healthc Chronic Illn 2011, 3:456-468.
• [42]Norman GR, Sloan JA, Wyrwich KW: Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care 2003, 41:582-592.
• [43]Steinsbekk A, Rygg LO, Lisulo M, Rise MB, Fretheim A: Group based diabetes self-management education compared to routine treatment for people with type 2 diabetes mellitus. A systematic review with meta-analysis. BMC Health Serv Res 2012, 12:213. BioMed Central Full Text