TY - JOUR
T1 - The effectiveness of a value-based EMOtion-cognition-Focused educatIonal programme to reduce diabetes-related distress in Malay adults with Type 2 diabetes (VEMOFIT)
T2 - Study protocol for a cluster randomised controlled trial
AU - Chew, BH
AU - Vos, Rimke C.
AU - Shariff Ghazali, Sazlina
AU - Shamsuddin, Nurainul Hana
AU - Fernandez, Aaron
AU - Mukhtar, Firdaus
AU - Ismail, Mastura
AU - Mohd Ahad, Azainorsuzila
AU - Sundram, Narayanan N.
AU - Ali, Siti Zubaidah Mohd
AU - Rutten, Guy E H M
N1 - Funding Information:
The trial is funded by the Malaysian MOH-NIH Research Grant (MRG). This funding source had no role in the design of this study and will not have any role during its execution, analyses, interpretation of the data, or decision to submit results. MRG can be contacted at the Secretariat National Institutes of Health (NIH) Ministry of Health Malaysia, c/o Institut Pengurusan Kesihatan Jalan Rumah Sakit Bangsar 59000 Kuala Lumpur; telephone: 03 – 2287 4032/ 2282 0491/2282 9085/2282 9082; fax : 03 2287 4030/2282 8072, and email: [email protected].
Publisher Copyright:
© 2017 The Author(s).
PY - 2017/4/4
Y1 - 2017/4/4
N2 - Background: Type 2 diabetes mellitus (T2DM) patients experience many psychosocial problems related to their diabetes. These often lead to emotional disorders such as distress, stress, anxiety and depression, resulting in decreased self-care, quality of life and disease control. The purpose of the current study is to evaluate the effectiveness of a brief value-based emotion-focused educational programme in adults with T2DM on diabetes-related distress (DRD), depressive symptoms, illness perceptions, quality of life, diabetes self-efficacy, self-care and clinical outcomes. Methods: A cluster randomised controlled trial will be conducted in 10 public health clinics in Malaysia, all providing diabetes care according to national clinical practice guidelines. Patients' inclusion criteria: Malay, ≥ 18 years with T2DM for at least 2 years, on regular follow-up with one of three biomarkers HbA1c, systolic blood pressure and LDL-cholesterol sub-optimally controlled, and with a mean 17-item Diabetes Distress Scale (DDS-17) score ≥ 3. The intervention consists of four sessions and one booster over a period of 4 months that provide information and skills to assist patients in having proper perceptions of their T2DM including an understanding of the treatment targets, understanding and managing their emotions and goal-setting. The comparator is an attention-control group with three meetings over a similar period. With an estimated intra-cluster correlation coefficient ρ of 0.015, a cluster size of 20 and 20% non-completion, the trial will need to enroll 198 patients. Primary outcome: the between groups difference in proportion of patients achieving a mean DDS-17 score <3 (non-significant distress) at 6 months post-intervention. Secondary outcomes will be the differences in the above mentioned variables between groups. Discussion: We hypothesize that primary and secondary outcomes will improve significantly after the intervention compared to the comparator group. The results of this study can contribute to better care for T2DM patients with DRD. Trial registration: ClinicalTrials.gov NCT02730078. Registered on 29 March 2016, last updated on 4 January 2017.
AB - Background: Type 2 diabetes mellitus (T2DM) patients experience many psychosocial problems related to their diabetes. These often lead to emotional disorders such as distress, stress, anxiety and depression, resulting in decreased self-care, quality of life and disease control. The purpose of the current study is to evaluate the effectiveness of a brief value-based emotion-focused educational programme in adults with T2DM on diabetes-related distress (DRD), depressive symptoms, illness perceptions, quality of life, diabetes self-efficacy, self-care and clinical outcomes. Methods: A cluster randomised controlled trial will be conducted in 10 public health clinics in Malaysia, all providing diabetes care according to national clinical practice guidelines. Patients' inclusion criteria: Malay, ≥ 18 years with T2DM for at least 2 years, on regular follow-up with one of three biomarkers HbA1c, systolic blood pressure and LDL-cholesterol sub-optimally controlled, and with a mean 17-item Diabetes Distress Scale (DDS-17) score ≥ 3. The intervention consists of four sessions and one booster over a period of 4 months that provide information and skills to assist patients in having proper perceptions of their T2DM including an understanding of the treatment targets, understanding and managing their emotions and goal-setting. The comparator is an attention-control group with three meetings over a similar period. With an estimated intra-cluster correlation coefficient ρ of 0.015, a cluster size of 20 and 20% non-completion, the trial will need to enroll 198 patients. Primary outcome: the between groups difference in proportion of patients achieving a mean DDS-17 score <3 (non-significant distress) at 6 months post-intervention. Secondary outcomes will be the differences in the above mentioned variables between groups. Discussion: We hypothesize that primary and secondary outcomes will improve significantly after the intervention compared to the comparator group. The results of this study can contribute to better care for T2DM patients with DRD. Trial registration: ClinicalTrials.gov NCT02730078. Registered on 29 March 2016, last updated on 4 January 2017.
KW - Blood pressure
KW - Depression
KW - Diabetes education
KW - Diabetes-related distress
KW - HbA1c
KW - LDL-cholesterol
KW - Quality of life
KW - Self-care
KW - Type 2 diabetes mellitus
UR - https://www.scopus.com/pages/publications/85017027416
U2 - 10.1186/s12902-017-0172-8
DO - 10.1186/s12902-017-0172-8
M3 - Article
C2 - 28376921
AN - SCOPUS:85017027416
SN - 1472-6823
VL - 17
JO - BMC Endocrine Disorders [E]
JF - BMC Endocrine Disorders [E]
IS - 1
M1 - 22
ER -