Diabetes Mellitus, Type 2NCT04278742
A Collaborative Approach in Diabetes Foot Education - A Pragmatic Randomised Control Trial
A study testing Patient education in people with Diabetes Mellitus, Type 2 and Neuropathy;Peripheral, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
Traditional directive style of requesting or demanding compliance to set behavior is found to have little effect on patient's self-care behavior. It is reported that patients prefer to restate or rephrase their understanding in a care setting, instead of a directive/didactic approach where the clinician provides… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Neuropathy;Peripheral
- What is being tested?
- Patient education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteSingapore
- Study dates
- 3 Dec 2018to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed type II diabetes
- Above age 21
- Plantar foot ulcer - high risk with active full-thickness ulcer
- Pedal pulses palpable or min toe pressure of 30mmHg
- Medium of language: English
- Activities of daily living (ADL) independent (without carer)
Who cannot join
- Diagnosed mental health conditions
- Diagnosed cognitive impairment
- Diagnosed visual impairment
- Diagnosed hearing and speech disabilities
Trial locations and contacts
1 site in 1 country.
About this study
Traditional directive style of requesting or demanding compliance to set behavior is found to have little effect on patient's self-care behavior. It is reported that patients prefer to restate or rephrase their understanding in a care setting, instead of a directive/didactic approach where the clinician provides 'one-way' information. In fact, directive persuasion is thought to lead to resistance to change and is counter-effective.
New approaches such as open ended communication, interview style and collaborative approach is found to engage patients better in their own care and elicit patient's own intrinsic motivations for making changes. One way to do this is to
Read more
- invite patient to share their thoughts or concerns then
- clarify patient's understanding
From their responses:
(3a) affirm patient's correct understanding or (3b) address misconceptions with permission.
In this study, the investigators will randomize 240 subjects into two groups: Group A will undergo the above describe collaborative approach to patient education and counselling; Group B will undergo current (traditional, didactic approach) patient education. It is hypothesized that the collaborative approach group (Group A) should experience better understand of their health condition and foot ulcer, be better able to adhere to treatment plan through collaborative participation and overall be more satisfied with the treatment. Outcomes will be tracked at (i) post intervention and (ii) 4 months post intervention.
- Conditions
- Diabetes Mellitus, Type 2, Neuropathy;Peripheral
- Being tested
- Patient education
- Keywords
- patient education
- Medical subject headings
- Diabetes Mellitus, Type 2, Neuritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient educationOther
Also called Collaborative counselling
Using a collaborative approach to engage patients in their own care, allowing patients to continue to have full control of their treatment. The clinician and patient co-creates the treatment plan.
| Study group | Role | What they receive |
|---|---|---|
| Interventional - collaborative education | Experimental | Collaborative style of communication whereby the clinician and patient co-creates the treatment plan Receives: Other: Patient education |
| Control group | No intervention | Traditional directive and didactic style of patient information will be provided |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing
Percentage patients with healed wound (wound size = 0cm)
Measured: 12 weeks
Secondary outcomes (2)
Knowledge score assessed by questionnaire
Knowledge score in Knowledge \& Behaviour questionnaire (Maximum score 16)
Measured: Week 1 and week 12
Behaviour score assessed by questionnaire
Behaviour score in Knowledge \& Behaviour questionnaire (Maximum score 59)
Measured: Week 1 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start3 Dec 2018
- Primary completionMar 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Suitable participants recruited and randomised into Study Intervention Group or Control Group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marabelle Heng, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04278742
- Sponsor's protocol ID
- SGH_collab_edu
- Status last verified
- Mar 2020
- First submitted
- 17 Dec 2018
- Last updated
- 19 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will only be available to the PI. The study team will be analysing de-identified data
Publications
Gabbay RA, Kaul S, Ulbrecht J, Scheffler NM, Armstrong DG. Motivational interviewing by podiatric physicians: a method for improving patient self-care of the diabetic foot. J Am Podiatr Med Assoc. 2011 Jan-Feb;101(1):78-84. doi: 10.7547/1010078.
PubMed 21242475Kemp EC, Floyd MR, McCord-Duncan E, Lang F. Patients prefer the method of "tell back-collaborative inquiry" to assess understanding of medical information. J Am Board Fam Med. 2008 Jan-Feb;21(1):24-30. doi: 10.3122/jabfm.2008.01.070093.
PubMed 18178699
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Collaborative Approach in Diabetes Foot Education - A Pragmatic Randomised Control Trial
- ClinicalTrials.gov ID
- NCT04278742
- Acronym / sponsor ID
- SGH_collab_edu
- Conditions
- Diabetes Mellitus, Type 2, Neuropathy;Peripheral
- Keywords
- patient education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 20 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Traditional directive style of requesting or demanding compliance to set behavior is found to have little effect on patient's self-care behavior. It is reported that patients prefer to restate or rephrase their understanding in a care setting, instead of a directive/didactic approach where the clinician provides 'one-way' information. In fact, directive persuasion is thought to lead to resistance to change and is counter-effective.
New approaches such as open ended communication, interview style and collaborative approach is found to engage patients better in their own care and elicit patient's own intrinsic motivations for making changes. One way to do this is to
- invite patient to share their thoughts or concerns then
- clarify patient's understanding
From their responses:
(3a) affirm patient's correct understanding or (3b) address misconceptions with permission.
In this study, the investigators will randomize 240 subjects into two groups: Group A will undergo the above describe collaborative approach to patient education and counselling; Group B will undergo current (traditional, didactic approach) patient education. It is hypothesized that the collaborative approach group (Group A) should experience better understand of their health condition and foot ulcer, be better able to adhere to treatment plan through collaborative participation and overall be more satisfied with the treatment. Outcomes will be tracked at (i) post intervention and (ii) 4 months post intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Suitable participants recruited and randomised into Study Intervention Group or Control Group.
| Arm | Type | Receives |
|---|---|---|
| Interventional - collaborative education | Experimental | Other: Patient educationCollaborative style of communication whereby the clinician and patient co-creates the treatment plan |
| Control group | No intervention | –Traditional directive and didactic style of patient information will be provided |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed type II diabetes
- Above age 21
- Plantar foot ulcer - high risk with active full-thickness ulcer
- Pedal pulses palpable or min toe pressure of 30mmHg
- Medium of language: English
Key exclusion criteria (4 listed)
- Diagnosed mental health conditions
- Diagnosed cognitive impairment
- Diagnosed visual impairment
- Diagnosed hearing and speech disabilities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient educationAlso: Collaborative counsellingUsing a collaborative approach to engage patients in their own care, allowing patients to continue to have full control of their treatment. The clinician and patient co-creates the treatment plan. | Other | Interventional - collaborative education |
Primary outcome
Wound healing
Time frame: 12 weeks
Percentage patients with healed wound (wound size = 0cm)
2 secondary outcomes
Knowledge score assessed by questionnaire
Time frame: Week 1 and week 12
Behaviour score assessed by questionnaire
Time frame: Week 1 and week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
- Background: PubMed 21242475Gabbay RA, Kaul S, Ulbrecht J, Scheffler NM, Armstrong DG. Motivational interviewing by podiatric physicians: a method for improving patient self-care of the diabetic foot. J Am Podiatr Med Assoc. 2011 Jan-Feb;101(1):78-84. doi: 10.7547/1010078.
- Background: PubMed 18178699Kemp EC, Floyd MR, McCord-Duncan E, Lang F. Patients prefer the method of "tell back-collaborative inquiry" to assess understanding of medical information. J Am Board Fam Med. 2008 Jan-Feb;21(1):24-30. doi: 10.3122/jabfm.2008.01.070093.
- Individual participant dataSharing planned: No. Individual participant data will only be available to the PI. The study team will be analysing de-identified data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marabelle Heng principal investigator
Singapore General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient education in people with Diabetes Mellitus, Type 2 and Neuropathy;Peripheral, run by Singapore General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04278742, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2020.