Telemedicine Follow-up in Primary Health Care for Diabetes-related Foot Ulcers (DiaFOTo)
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Purpose
This study will investigate whether telemedicine follow-up care for people with diabetes-related foot ulcers in municipal primary health care in collaboration with specialist health care is an equivalent alternative to traditional outpatient clinical follow-up in specialist health care (noninferiority trial) in relation to healing time.
| Condition | Intervention |
|---|---|
|
Diabetic Foot Foot Ulcer |
Procedure: Telemedicine follow-up care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effect of Telemedicine Follow-up Care in Primary Health Care Versus Traditional Follow-up in Specialist Health Care on the Healing Time for Diabetes-related Foot Ulcers - a Cluster-randomized Controlled Trial |
- healing time for diabetes related foot ulcer [ Time Frame: one year ] [ Designated as safety issue: No ]Healing time for diabetes related foot ulcer measured from the time the person is included in the study until the foot ulcer is healed or the study ends (after 12 months).
- Total number of consultations per person at the Section of Endocrinology [ Time Frame: one year ] [ Designated as safety issue: No ]Number of consultations from baseline until the foot ulcer has healed
- sequela directly related to the foot ulcer [ Time Frame: one year ] [ Designated as safety issue: No ]From baseline until the foot ulcer has healed sequelae directly related to the foot ulcer: infection, hospitalization, osteomyelitis and vascular surgery during the study
- Diabetes-related stress [ Time Frame: one year ] [ Designated as safety issue: No ]Diabetes-related stress, measured by using the Problem Areas in Diabetes. Measured at baseline and when the ulcer has healed (or the end of the study)
- Symptoms of anxiety and depression [ Time Frame: one year ] [ Designated as safety issue: No ]symptoms of anxiety and depression, measured by using the Hospital Anxiety and Depression Scale at baseline and the end of the study.
- Nordic Patient Experiences Questionnaire [ Time Frame: one year ] [ Designated as safety issue: No ]Patient satisfaction with health care, measured by using the Nordic Patient Experiences Questionnaire. Measured at baseline and the end of the study.
- EQ-5D [ Time Frame: one year ] [ Designated as safety issue: No ]Health status and cost utility, measured by using the EQ-5D from the EuroQol Group at baseline and the end of the study.
- Sick leave [ Time Frame: one year ] [ Designated as safety issue: No ]Sick leave (number of days with a medical certificate) measured by obtaining data from the Norwegian Sick Leave Registry measured from baseline unntil the ulcer is healed (or at the end of the study)
- A new foot ulcer appears, the incidence of amputation and survival. [ Time Frame: 2 and 3 years after the end of the study ] [ Designated as safety issue: No ]The time elapsing before a new foot ulcer appears, the incidence of amputation and survival.
| Estimated Enrollment: | 276 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | October 2019 |
| Estimated Primary Completion Date: | October 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Traditional follow-up
Traditional follow-up with standard consultations at the Section of Endocrinology. For some patients, this will include follow-up from nurses in the home care or general practice office related to wound care. However, this is not the standard procedure and will not take place in combination with telemedicine follow-up.
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Active Comparator: Telemedicine follow-up care
Telemedicine follow-up care for people with diabetes-related foot ulcers in municipal primary health care in collaboration with specialist health care
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Procedure: Telemedicine follow-up care
Telemedicine follow-up care for people with diabetes-related foot ulcers in municipal primary health care in collaboration with specialist health care
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Detailed Description:
The increasing prevalence of diabetes, especially type 2 diabetes, combined with a steadily increasing proportion of older people in the population, will present enormous challenges for health care services in Norway. An epidemiologic study of diabetes-related foot ulcers among community-dwelling adults, including older people, based on data from the Nord-Trøndelag Health Study (HUNT2) showed that a history of foot ulcer was significantly associated with increased mortality and that about 10% of the people with diabetes reported a history of foot ulcer. Studies have shown that a foot ulcer is associated with reduced quality of life, social limitations and pain. Treating foot ulcers costs society considerable money. These results emphasize that diabetes-related foot ulcers represent a challenge for the individual and for health care services. Health care services need to rapidly begin treatment for people with diabetes-related foot ulcers to ensure high-quality treatment.
Telemedicine innovations for health care services have developed considerably in recent decades. The National Health Plan for Norway (2007-2010) emphasizes that the use of information and communication technologies is an important way of achieving health policy aims in establishing more integrated diagnosis, treatment and care pathways across organizational boundaries. Qualitative studies of diabetes-related foot ulcers have shown that using telemedicine equipment enables follow-up care of similar quality to traditional consultations while enabling more flexible organization and greater patient satisfaction. A few minor quantitative studies show positive gains when telemedicine equipment is used in following up diabetes-related foot ulcers, but no randomized controlled studies have been performed in this field. Further, studies focusing on the more long-term effects are lacking.
The project is in accordance with national guidelines and will contribute to increasing the focus on research related to integrated care. We expect this project to provide evidence about alternative care pathways with a holistic approach that could moderate increases in the cost of health care services by delivering a larger proportion of services in municipal primary care. The project will be able to provide new evidence on meeting the challenges of diabetes-related care more systematically and proactively. We expect that the results of this study will contribute to showing the extent to which treatment at the lowest effective service level will be more cost-effective and of good or better quality than traditional clinical follow-up. This study can and will contribute to setting priorities for the users' needs for flexible health services and enabling more patients to be treated near their homes.
If the study finds evidence of positive health gains for the individual people with diabetes and contributes to high quality of care, this new model can be implemented in the entire Stavanger Hospital Trust. This approach will enable the multidisciplinary team in specialist health care to be used more appropriately, and the team will be more accessible for health care personnel in municipal primary health care. This model can be transferred to other hospital trusts and contribute to improving knowledge on diabetes among nurses in municipal primary health care.
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- people with type 1 or type 2 diabetes with a new foot ulcer presenting for the first time within a period of 6 months to the Section of Endocrinology of Stavanger University Hospital.
- The participants must be able to read and speak Norwegian.
- The participants must be 20 years or older.
Exclusion Criteria:
- people treated for an ulcer on the ipsilateral foot during the past 6 months in specialist health care
- people with life expectancy of less than 1 year because of anticipated problems with follow-up
- people with severe mental disorders or cognitive impairment, including schizophrenia, other psychotic disorders and dementia
Contacts and Locations| Norway | |
| Stavanger HF | Recruiting |
| Stavanger, Rogaland, Norway, 4068 | |
| Contact: Marjolein M. Iversen, PhD +47 55 58 55 18 miv@hib.no | |
| Contact: Berit Rokne, PhD +47 55 58 83 58 berit.rokne@rektor.uib.no | |
| Principal Investigator: | Marjolein M. Iversen, PhD | Helse Stavanger HF |
More Information
No publications provided
| Responsible Party: | Marjolein M. Iversen, Post doc, Helse Stavanger HF |
| ClinicalTrials.gov Identifier: | NCT01710774 History of Changes |
| Other Study ID Numbers: | SUS-ID210 |
| Study First Received: | October 17, 2012 |
| Last Updated: | October 17, 2012 |
| Health Authority: | Norway: Regional Ethics Commitee |
Keywords provided by Helse Stavanger HF:
|
Diabetic Foot Diabetes Mellitus Foot Ulcer Wound Healing Delivery of Health Care |
Depression sequela Sick Leave Quality of Life Amputation |
Additional relevant MeSH terms:
|
Foot Ulcer Diabetic Foot Foot Diseases Ulcer Pathologic Processes Skin Diseases Leg Ulcer Skin Ulcer |
Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Diabetic Neuropathies |
ClinicalTrials.gov processed this record on May 21, 2013