Clinical trial NCT04370106: The Impact of Frequenting a Social Leg Program on Therapeutic Adherence and Venous Leg Ulcer Wound Healing Outcomes
Official title: The Impact of Frequenting a Social Leg Program on Therapeutic Adherence and Venous Leg Ulcer Wound Healing Outcomes: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Venous Leg Ulcer
Social Interaction
Keywords: leg club
education
recurrence
Lead sponsor: School of Health Sciences Geneva
Sponsor class: OTHER
First posted: 2020-04-30
Enrollment: 268
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Background and rationale: Venous leg ulcers (VLU) are slow healing wounds with a recurrence rate up to 70% and a 60% risk of becoming chronic. Currently the Swiss health care system does not take in consideration social and educational needs and support for VLU patients who transition from acute care (hospital care, outpatient care) to home based self-care. To fill this gap, this study proposes to create the Social Legs Program (SLP).

Overall objectives: The objectives of the proposed study are to evaluate the impact of a frequented SLP for patients with VLU in terms of their therapeutic adherence and wound healing outcomes (wound size and wound recurrence).

Methodology of the planned study: A randomized controlled trial with 268 participants in three Swiss French institutions is proposed.

Expected results and impact: The findings of this study will generate new knowledge about support and care management of persons with VLU who transition between acute care settings and home care settings. The findings will contribute to the evidence base of clinical practice guidelines for the care of patients with VLU.

Detailed description: Background and rationale: Venous leg ulcers (VLU) are slow healing wounds with a recurrence rate up to 70% and a 60% risk of becoming chronic. Signs and symptoms such as pain or exudate are not only a burden on those affected but also on the health care system and society in general. The estimated VLU prevalence in the general population is 3%. Treatment cost for VLU is estimated to be 4% of overall health expenditure. Current therapeutic approaches are multifaceted, focus on reducing wound size as well as preventing ulcer recurrence. Depending on the severity of the VLU treatment/care occurs in the hospital setting, outpatient setting or community setting. Currently the Swiss health care system does not take in consideration social and educational needs and support for VLU patients who transition from acute care (hospital care, outpatient care) to home based self-care. To fill this gap, this study proposes to create the Social Legs Program (SLP). This program is based on the existing Leg Club (LC) community model in the United Kingdom (UK) and will be adapted for the Swiss context. The SLP is designed to provide an environment for social interaction, peer and nursing/professional support, information sharing and personal involvement. Participation in the SLP will address the need for social and educational support in this patient group and will improve therapeutic adherence and result in enhanced wound healing as well as a reduction of the wound recurrence rate.

Overall objectives: The objectives of the proposed study are to evaluate the impact of a frequented SLP for patients with VLU in terms of their therapeutic adherence and wound healing outcomes (wound size and wound recurrence).

Specific aims: The impact of the intervention will be measured in terms of therapeutic adherence and wound healing outcomes as well as multidimensional complexity, wound assessment, patient satisfaction, depression, general nutrition, mobility and quality of sleep.

In addition, the incidence of complications (re-hospitalizations) will be measured (frequency and cost).

Methodology of the planned study: A randomized controlled trial with 268 participants in three Swiss French institutions is proposed. The study participants will be consecutive patients of the participating clinics who fulfill the inclusion criteria. Wound care will be performed according to the institutions standard clinical practice guidelines. Allocation to the intervention group (IG) or the control group (CG) will be concealed. The intervention will consist in participating in the SLP. The social program will provide patients with an opportunity to exchange and learn about the prevention measures such as the use of compression bandages, and how to prevent recurrences, and enhance healing outcomes. A study nurse, who will not be identical to the nurse in charge of the control group, will supervise this group. Due to the intervention being a social program, the study cannot be blinded for either the participants or the staff performing the intervention. The sample size assumptions are based on an adjusted (Bonferroni) two-sided alpha level of 0.05, power of 0.8, and clinically relevant effect sizes and a loss to follow up of 20%. Univariate and bivariate analysis will be conducted according to the data level.

Expected results and impact: The findings of this study will generate new knowledge about support and care management of persons with VLU who transition between acute care settings and home care settings. The findings will contribute to the evidence base of clinical practice guidelines for the care of patients with VLU. Additionally, it is in alignment with the National Strategy on the Prevention of Non-Communicable Diseases 2017 - 2024 establishing prevention work for people with enhanced risks and chronic conditions reinforcing a better social integration.

Eligibility criteria: Inclusion Criteria:

* 18 years or older,
* with an existing diagnosed open VLU,
* an ulcer surface \<2 cm2 or having a healed VLU,
* proficiency in the French language

Exclusion Criteria:

- Valid informed consent is not or cannot be given

Primary outcomes:
measure: Adherence to therapy
timeFrame: six months
measure: Wound healing
timeFrame: six months
measure: Wound recurrence
timeFrame: six months
Secondary outcomes:
measure: Wound Assessment
timeFrame: six months
measure: Self care
timeFrame: six months
measure: Depression
timeFrame: six months
measure: Multidimensional complexity
timeFrame: six months
measure: General nutritional status
timeFrame: six months
measure: Patient Satisfaction
timeFrame: six months
Other outcomes:
Locations:
city: Carouge
country: Switzerland
facility: IMAD
state: GE
city: Onex
country: Switzerland
facility: Cité Génération Maison de santé
state: GE
Study officials:
affiliation: HES-SO University of Applied Sciences and Arts Western Switzerland
name: Sebastian E Probst, Prof Dr
role: PRINCIPAL_INVESTIGATOR
References: