Web-based self-management support for people with type 2 diabetes (HeLP-Diabetes): randomised controlled trial in English primary care

Elizabeth Murray; Michael Sweeting; Charlotte Dack; Kingshuk Pal; Kerstin Modrow; Mohammed Hudda; Jinshuo Li; Jamie Ross; Ghadah Alkhaldi; Maria Barnard; Andrew Farmer; Susan Michie; Lucy Yardley; Carl May; Steve Parrott; Fiona Stevenson; Malcolm Knox; David Patterson

doi:10.1136/bmjopen-2017-016009

Web-based self-management support for people with type 2 diabetes (HeLP-Diabetes): randomised controlled trial in English primary care

Elizabeth Murray^*, Michael Sweeting, Charlotte Dack, Kingshuk Pal, Kerstin Modrow, Mohammed Hudda, Jinshuo Li, Jamie Ross, Ghadah Alkhaldi, Maria Barnard, Andrew Farmer, Susan Michie, Lucy Yardley, Carl May, Steve Parrott, Fiona Stevenson, Malcolm Knox, David Patterson

^*Corresponding author for this work

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Abstract

OBJECTIVE: To determine the effectiveness of a web-based self-management programme for people with type 2 diabetes in improving glycaemic control and reducing diabetes-related distress.

METHODS AND DESIGN: Individually randomised two-arm controlled trial.

SETTING: 21 general practices in England.

PARTICIPANTS: Adults aged 18 or over with a diagnosis of type 2 diabetes registered with participating general practices.

INTERVENTION AND COMPARATOR: Usual care plus either Healthy Living for People with Diabetes (HeLP-Diabetes), an interactive, theoretically informed, web-based self-management programme or a simple, text-based website containing basic information only.

OUTCOMES AND DATA COLLECTION: Joint primary outcomes were glycated haemoglobin (HbA1c) and diabetes-related distress, measured by the Problem Areas in Diabetes (PAID) scale, collected at 3 and 12 months after randomisation, with 12 months the primary outcome point. Research nurses, blind to allocation collected clinical data; participants completed self-report questionnaires online.

ANALYSIS: The analysis compared groups as randomised (intention to treat) using a linear mixed effects model, adjusted for baseline data with multiple imputation of missing values.

RESULTS: Of the 374 participants randomised between September 2013 and December 2014, 185 were allocated to the intervention and 189 to the control. Final (12 month) follow-up data for HbA1c were available for 318 (85%) and for PAID 337 (90%) of participants. Of these, 291 (78%) and 321 (86%) responses were recorded within the predefined window of 10-14 months. Participants in the intervention group had lower HbA1c than those in the control (mean difference -0.24%; 95% CI -0.44 to -0.049; p=0.014). There was no significant overall difference between groups in the mean PAID score (p=0.21), but prespecified subgroup analysis of participants who had been more recently diagnosed with diabetes showed a beneficial impact of the intervention in this group (p = 0.004). There were no reported harms.

CONCLUSIONS: Access to HeLP-Diabetes improved glycaemic control over 12 months.

TRIAL REGISTRATION NUMBER: ISRCTN02123133.

Original language	English
Article number	e016009
Number of pages	11
Journal	BMJ Open
Volume	7
Issue number	9
DOIs	https://doi.org/10.1136/bmjopen-2017-016009
Publication status	Published - 27 Sept 2017

Research Groups and Themes

Physical and Mental Health
Digital Health

Keywords

Adult
Blood Glucose/analysis
Diabetes Mellitus, Type 2/therapy
England
Female
Glycated Hemoglobin A/analysis
Humans
Internet
Male
Primary Health Care
Quality of Life
Self Care/methods
Self Report
Self-Management

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Murray, E., Sweeting, M., Dack, C., Pal, K., Modrow, K., Hudda, M., Li, J., Ross, J., Alkhaldi, G., Barnard, M., Farmer, A., Michie, S., Yardley, L., May, C., Parrott, S., Stevenson, F., Knox, M., & Patterson, D. (2017). Web-based self-management support for people with type 2 diabetes (HeLP-Diabetes): randomised controlled trial in English primary care. BMJ Open, 7(9), Article e016009. https://doi.org/10.1136/bmjopen-2017-016009

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title = "Web-based self-management support for people with type 2 diabetes (HeLP-Diabetes): randomised controlled trial in English primary care",

abstract = "OBJECTIVE: To determine the effectiveness of a web-based self-management programme for people with type 2 diabetes in improving glycaemic control and reducing diabetes-related distress.METHODS AND DESIGN: Individually randomised two-arm controlled trial.SETTING: 21 general practices in England.PARTICIPANTS: Adults aged 18 or over with a diagnosis of type 2 diabetes registered with participating general practices.INTERVENTION AND COMPARATOR: Usual care plus either Healthy Living for People with Diabetes (HeLP-Diabetes), an interactive, theoretically informed, web-based self-management programme or a simple, text-based website containing basic information only.OUTCOMES AND DATA COLLECTION: Joint primary outcomes were glycated haemoglobin (HbA1c) and diabetes-related distress, measured by the Problem Areas in Diabetes (PAID) scale, collected at 3 and 12 months after randomisation, with 12 months the primary outcome point. Research nurses, blind to allocation collected clinical data; participants completed self-report questionnaires online.ANALYSIS: The analysis compared groups as randomised (intention to treat) using a linear mixed effects model, adjusted for baseline data with multiple imputation of missing values.RESULTS: Of the 374 participants randomised between September 2013 and December 2014, 185 were allocated to the intervention and 189 to the control. Final (12 month) follow-up data for HbA1c were available for 318 (85%) and for PAID 337 (90%) of participants. Of these, 291 (78%) and 321 (86%) responses were recorded within the predefined window of 10-14 months. Participants in the intervention group had lower HbA1c than those in the control (mean difference -0.24%; 95% CI -0.44 to -0.049; p=0.014). There was no significant overall difference between groups in the mean PAID score (p=0.21), but prespecified subgroup analysis of participants who had been more recently diagnosed with diabetes showed a beneficial impact of the intervention in this group (p = 0.004). There were no reported harms.CONCLUSIONS: Access to HeLP-Diabetes improved glycaemic control over 12 months.TRIAL REGISTRATION NUMBER: ISRCTN02123133.",

keywords = "Adult, Blood Glucose/analysis, Diabetes Mellitus, Type 2/therapy, England, Female, Glycated Hemoglobin A/analysis, Humans, Internet, Male, Primary Health Care, Quality of Life, Self Care/methods, Self Report, Self-Management",

author = "Elizabeth Murray and Michael Sweeting and Charlotte Dack and Kingshuk Pal and Kerstin Modrow and Mohammed Hudda and Jinshuo Li and Jamie Ross and Ghadah Alkhaldi and Maria Barnard and Andrew Farmer and Susan Michie and Lucy Yardley and Carl May and Steve Parrott and Fiona Stevenson and Malcolm Knox and David Patterson",

note = "{\textcopyright} Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.",

year = "2017",

month = sep,

day = "27",

doi = "10.1136/bmjopen-2017-016009",

language = "English",

volume = "7",

journal = "BMJ Open",

issn = "2044-6055",

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Murray, E, Sweeting, M, Dack, C, Pal, K, Modrow, K, Hudda, M, Li, J, Ross, J, Alkhaldi, G, Barnard, M, Farmer, A, Michie, S, Yardley, L , May, C, Parrott, S, Stevenson, F, Knox, M & Patterson, D 2017, 'Web-based self-management support for people with type 2 diabetes (HeLP-Diabetes): randomised controlled trial in English primary care', BMJ Open, vol. 7, no. 9, e016009. https://doi.org/10.1136/bmjopen-2017-016009

TY - JOUR

T1 - Web-based self-management support for people with type 2 diabetes (HeLP-Diabetes)

T2 - randomised controlled trial in English primary care

AU - Murray, Elizabeth

AU - Sweeting, Michael

AU - Dack, Charlotte

AU - Pal, Kingshuk

AU - Modrow, Kerstin

AU - Hudda, Mohammed

AU - Li, Jinshuo

AU - Ross, Jamie

AU - Alkhaldi, Ghadah

AU - Barnard, Maria

AU - Farmer, Andrew

AU - Michie, Susan

AU - Yardley, Lucy

AU - May, Carl

AU - Parrott, Steve

AU - Stevenson, Fiona

AU - Knox, Malcolm

AU - Patterson, David

PY - 2017/9/27

Y1 - 2017/9/27

N2 - OBJECTIVE: To determine the effectiveness of a web-based self-management programme for people with type 2 diabetes in improving glycaemic control and reducing diabetes-related distress.METHODS AND DESIGN: Individually randomised two-arm controlled trial.SETTING: 21 general practices in England.PARTICIPANTS: Adults aged 18 or over with a diagnosis of type 2 diabetes registered with participating general practices.INTERVENTION AND COMPARATOR: Usual care plus either Healthy Living for People with Diabetes (HeLP-Diabetes), an interactive, theoretically informed, web-based self-management programme or a simple, text-based website containing basic information only.OUTCOMES AND DATA COLLECTION: Joint primary outcomes were glycated haemoglobin (HbA1c) and diabetes-related distress, measured by the Problem Areas in Diabetes (PAID) scale, collected at 3 and 12 months after randomisation, with 12 months the primary outcome point. Research nurses, blind to allocation collected clinical data; participants completed self-report questionnaires online.ANALYSIS: The analysis compared groups as randomised (intention to treat) using a linear mixed effects model, adjusted for baseline data with multiple imputation of missing values.RESULTS: Of the 374 participants randomised between September 2013 and December 2014, 185 were allocated to the intervention and 189 to the control. Final (12 month) follow-up data for HbA1c were available for 318 (85%) and for PAID 337 (90%) of participants. Of these, 291 (78%) and 321 (86%) responses were recorded within the predefined window of 10-14 months. Participants in the intervention group had lower HbA1c than those in the control (mean difference -0.24%; 95% CI -0.44 to -0.049; p=0.014). There was no significant overall difference between groups in the mean PAID score (p=0.21), but prespecified subgroup analysis of participants who had been more recently diagnosed with diabetes showed a beneficial impact of the intervention in this group (p = 0.004). There were no reported harms.CONCLUSIONS: Access to HeLP-Diabetes improved glycaemic control over 12 months.TRIAL REGISTRATION NUMBER: ISRCTN02123133.

AB - OBJECTIVE: To determine the effectiveness of a web-based self-management programme for people with type 2 diabetes in improving glycaemic control and reducing diabetes-related distress.METHODS AND DESIGN: Individually randomised two-arm controlled trial.SETTING: 21 general practices in England.PARTICIPANTS: Adults aged 18 or over with a diagnosis of type 2 diabetes registered with participating general practices.INTERVENTION AND COMPARATOR: Usual care plus either Healthy Living for People with Diabetes (HeLP-Diabetes), an interactive, theoretically informed, web-based self-management programme or a simple, text-based website containing basic information only.OUTCOMES AND DATA COLLECTION: Joint primary outcomes were glycated haemoglobin (HbA1c) and diabetes-related distress, measured by the Problem Areas in Diabetes (PAID) scale, collected at 3 and 12 months after randomisation, with 12 months the primary outcome point. Research nurses, blind to allocation collected clinical data; participants completed self-report questionnaires online.ANALYSIS: The analysis compared groups as randomised (intention to treat) using a linear mixed effects model, adjusted for baseline data with multiple imputation of missing values.RESULTS: Of the 374 participants randomised between September 2013 and December 2014, 185 were allocated to the intervention and 189 to the control. Final (12 month) follow-up data for HbA1c were available for 318 (85%) and for PAID 337 (90%) of participants. Of these, 291 (78%) and 321 (86%) responses were recorded within the predefined window of 10-14 months. Participants in the intervention group had lower HbA1c than those in the control (mean difference -0.24%; 95% CI -0.44 to -0.049; p=0.014). There was no significant overall difference between groups in the mean PAID score (p=0.21), but prespecified subgroup analysis of participants who had been more recently diagnosed with diabetes showed a beneficial impact of the intervention in this group (p = 0.004). There were no reported harms.CONCLUSIONS: Access to HeLP-Diabetes improved glycaemic control over 12 months.TRIAL REGISTRATION NUMBER: ISRCTN02123133.

KW - Adult

KW - Blood Glucose/analysis

KW - Diabetes Mellitus, Type 2/therapy

KW - England

KW - Female

KW - Glycated Hemoglobin A/analysis

KW - Humans

KW - Internet

KW - Male

KW - Primary Health Care

KW - Quality of Life

KW - Self Care/methods

KW - Self Report

KW - Self-Management

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U2 - 10.1136/bmjopen-2017-016009

DO - 10.1136/bmjopen-2017-016009

M3 - Article (Academic Journal)

C2 - 28954789

SN - 2044-6055

VL - 7

JO - BMJ Open

JF - BMJ Open

IS - 9

M1 - e016009

ER -

Web-based self-management support for people with type 2 diabetes (HeLP-Diabetes): randomised controlled trial in English primary care

Abstract

Research Groups and Themes

Keywords

UN SDGs

Access to Document

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