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

Web-based self-management support for people with type 2 diabetes (HeLP-Diabetes): randomised controlled trial in English primary care
Web-based self-management support for people with type 2 diabetes (HeLP-Diabetes): randomised controlled trial in English primary care
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
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 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 pre-defined “window” of 10-14 months. Participants in the intervention group had lower HbA1c than those in the control (mean difference -0.24%; 95% Confidence Interval -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 pre-specified subgroup analysis of participants who had had diabetes for less than 7 years 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.

Registration
Trial registration ISRCTN02123133.
2044-6055
Murray, Elizabeth
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Sweeting, Michael
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Dack, Charlotte
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Pal, Kingshuk
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Modrow, Kerstin
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Hudda, Mohammed
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Li, Jinshuo
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Ross, Jamie
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Alkhaldi, Ghadah
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Barnard, Maria
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Farmer, Andrew
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Michie, Susan
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Yardley, Lucy
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May, Carl
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Parrott, Steve
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Stevenson, Fiona
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Knox, Malcolm
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Patterson, David
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Murray, Elizabeth
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Sweeting, Michael
dc1d9e1b-4cd6-485a-b327-910d3431c173
Dack, Charlotte
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Pal, Kingshuk
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Modrow, Kerstin
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Hudda, Mohammed
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Li, Jinshuo
b4f29e27-d32d-4d02-965e-9bf01da91150
Ross, Jamie
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Alkhaldi, Ghadah
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Barnard, Maria
0fb01491-b1da-481b-84a5-36e20f525743
Farmer, Andrew
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Michie, Susan
47e0a907-79cb-47d5-b5a9-82d2afe1747a
Yardley, Lucy
64be42c4-511d-484d-abaa-f8813452a22e
May, Carl
17697f8d-98f6-40d3-9cc0-022f04009ae4
Parrott, Steve
9fcc1a2f-eae7-40d8-a795-3a96172018df
Stevenson, Fiona
881eb2a9-d7a8-449d-be50-ead6fda5cd3e
Knox, Malcolm
435fce80-4d8c-4065-bdbc-23b458faf669
Patterson, David
245c93f8-8e53-4cab-8ac8-3ce26b24244a

Murray, Elizabeth, Sweeting, Michael, Dack, Charlotte, Pal, Kingshuk, Modrow, Kerstin, Hudda, Mohammed, Li, Jinshuo, Ross, Jamie, Alkhaldi, Ghadah, Barnard, Maria, Farmer, Andrew, Michie, Susan, Yardley, Lucy, May, Carl, Parrott, Steve, Stevenson, Fiona, Knox, Malcolm and Patterson, David (2017) Web-based self-management support for people with type 2 diabetes (HeLP-Diabetes): randomised controlled trial in English primary care. BMJ Open, 7, [e016009]. (doi:10.1136/bmjopen-2017-016009).

Record type: Article

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
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 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 pre-defined “window” of 10-14 months. Participants in the intervention group had lower HbA1c than those in the control (mean difference -0.24%; 95% Confidence Interval -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 pre-specified subgroup analysis of participants who had had diabetes for less than 7 years 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.

Registration
Trial registration ISRCTN02123133.

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

Accepted/In Press date: 14 July 2017
e-pub ahead of print date: 27 September 2017
Published date: September 2017

Identifiers

Local EPrints ID: 412570
URI: http://eprints.soton.ac.uk/id/eprint/412570
ISSN: 2044-6055
PURE UUID: 7b0d39e5-7a7a-4d27-940a-df4c5ac5aba3
ORCID for Lucy Yardley: ORCID iD orcid.org/0000-0002-3853-883X
ORCID for Carl May: ORCID iD orcid.org/0000-0002-0451-2690

Catalogue record

Date deposited: 21 Jul 2017 16:31
Last modified: 18 Feb 2021 17:15

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