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Motivational interviewing to improve footwear adherence in diabetic patients


- candidate number21792
- NTR NumberNTR5097
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-mrt-2015
- Secondary IDsMETC 2012_286
- Public TitleMotivational interviewing to improve footwear adherence in diabetic patients
- Scientific TitleThe efficacy of the use of motivational interviewing to improve adherence to wearing prescribed footwear in diabetic patients: a Pilot Randomized Controlled Trial.
- ACRONYMMOTIVIEW trial
- hypothesisMotivational interviewing has a positive effect on footwear adherence in diabetic patients at high-risk of foot ulceration.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus, Diabetic neuropathy
- Inclusion criteria1. Age 18 or above;
2. Diabetes mellitus type 1 or 2;
3. History of foot ulceration;
4. Possesion of prescription footwear that is already worn for at least 3 months
- Exclusion criteria1. Current foot ulcer;
2. Inability to walk;
3. Participation in another study that may influence the study outcomes
4. Inability to read and understand the Dutch language or to follow the study instructions
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 23-jan-2013
- planned closingdate31-mei-2015
- Target number of participants30
- InterventionsIn patients with measured adherence <80%: two 45-min sessions of motivational interviewing & education as usual (intervention group) or education as usual (control group).
- Primary outcomeAdherence (%) to wearing prescribed footwear in diabetic foot patients 1 week and 3 months after the intervention.
- Secondary outcome1. Normal variability in prescribed footwear adherence over time (3,6,9 and 12 months);
2. Feasibility of motivational interviewing in diabetic foot patients;
3. Factors of non-adherence in wearing prescribed footwear
- TimepointsBaseline assessment;
Follow-up visits 1 week, 3, 6 9 and 12 months after the intervention.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES S.A. Bus
- CONTACT for SCIENTIFIC QUERIES S.A. Bus
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- Publicationsnone
- Brief summaryPrescribed footwear can be effective in preventing foot ulcer recurrence if it is worn as recommended. Previous research showed a low adherence to prescribed footwear in patients with diabetes at high-risk of foot ulceration. The aim of this pilot RCT is to assess the effect of motivational interviewing on adherence to wearing prescribed footwear in diabetic patients at high-risk of foot ulceration.
- Main changes (audit trail)
- RECORD12-mrt-2015 - 11-aug-2015


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