- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07608952
The Women Veteran's Health Mission
The purpose of this study is to evaluate the impact of a customized web-based e-health program to provide online health promotion (Missions), peer support, and social connectivity to women Veterans and their families.
Primary Objective
• To assess participant engagement in the program including:
completion rates (%) for each 6-12 week health program (Mission) defined as completing the assessments following the intervention number of login days among those who register and drop-out rates (%) defined as those who start but do not complete the program.
Secondary Objectives • To assess the impact of a web-based wellness program on health metrics including: change in body weight (lbs) sleep, and chronic pain (PROMIS 29 Questionnaire) stress (PROMIS Perceived Stress) social isolation (PROMIS Social Isolation Short Form 4a).
• To determine whether there is a dose-response between the number of login days into the program and changes in health metrics.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
For most Canadian Armed Forces (CAF) Veterans, the transition from military to civilian life is completed successfully. In the 2016 Life After Service Survey (LASS). However, 32% reported difficulties and it appears that this proportion has been rising among those most recently released. Moreover, 28% indicated that their partners had difficulty with the release. Among veterans, an increased prevalence of chronic health problems is believed to be one of the primary reasons for challenging transitions and ongoing difficulties with civilian life. The most common health issues are chronic back problems (41%), arthritis (29%), and mental health conditions including depression (21%), Post-Traumatic Stress Disorder (PTSD) (16%), and anxiety (15%).
A recent survey comparing Veterans to Canadians from the general population demonstrated that in age and sex adjusted analyses, both male and female Veterans were significantly more likely to suffer from the above mentioned physical and mental health conditions. Chronic pain was particularly noteworthy among Veteran men (39%) and women (49%) (Hall AL, Sweet J, Tweel M, MacLean MB. BMJ Mil Health. 2022 Feb;168(1):82-87. doi: 10.1136/bmjmilitary-2020-001526. Epub 2020 Aug 30. PMID: 32868291; PMCID: PMC8788043).
Regular physical activity has been shown to be an effective treatment for all the above conditions, both alone and in combination with other therapeutic options. Yet regular physical activity is challenging for most Canadians with or without with chronic health issues.
In 2024, Women Veterans testified in a Canadian Parliamentary Hearing about the discrimination they had faced during military service. They also spoke of the ongoing challenges associated with finding timely rehabilitation services for their health problems that had arisen during their time serving. (Invisible No More. The Experiences of Canadian Women Veterans: https://www.ourcommons.ca/DocumentViewer/en/44-1/ACVA/news-release/13150242). Release from the CAF also reduces social connectivity and a sense of community as Veterans try to re-integrate into society. Providing women veterans with peer-support programs for women only, was one of the final recommendations from this Parliamentary Hearing.
The investigators therefore propose to adapt a web-based program to engage women Veterans and their families in wellness challenges (Missions) to increase participants' physical activity, improve sleep, reduce stress, eat healthy, manage weight, etc. while increasing social connectivity and peer support. Online Chat Forums, monitored daily by the investigators, will also be available to support conversations among women Veterans focusing on common health and wellness issues.
While the primary focus will be Women Veterans, participants will be able to invite male or female friends/family members to join them on the wellness Missions. The Women Chat Forums will be open only to women participants and will focus on issues initially proposed by a steering committee of women Veterans and over time by the women participating in the program.
The Women Veterans Health Mission will be based on existing web-based programs previously designed and evaluated by the investigators. The cornerstone of the program will be to engage participants to track their daily physical activity in Missions typically lasting 6 to 12 weeks while they learn and practice other healthy lifestyle habits. The website will feature evidence-based educational modules covering topics such as improving sleep, stress management, managing pain, and healthy eating/weight loss. Participants will set health goals for themselves and track their behaviours and new skills online (physical activity, sleep hygiene practices, mindful relaxation, etc.).
Participants can also form a team of friends and family members and compete against other teams if they wish. Points are awarded for daily activity tracking, learning and practicing healthy lifestyle modules and new skills, measuring health outcomes (before and after the Mission), posting comments to other team members, etc. Teams can compare their progress on a leader board where accumulated points are displayed.
The investigators have tested these programs in the workplace, among university staff, and government employees. Published results demonstrated that among 730 eligible employees, 571 (78%) participated in the online wellness program in the first year resulting in significant improvements in blood pressure, sleep quality, emotional stress, and fatigue. A significant dose response was also noted where the greatest benefits were observed among those who used the online program the most. (https://pubmed.ncbi.nlm.nih.gov/29200188/.)
The investigators launched the MissionVAV program in 2019 with funding from the Veterans and Family Wellbeing Fund. The target population for this online wellness program was Canadian Veterans, family members, and friends. During the next 6 years 1868 participants including women who self-identified as: Veterans (93), family members of Veterans (204) or friends of Veterans (37).
Building on the foundations of the MissionVAV program, we will adapt the web-based platform to respond to the needs of enrolled Women veterans and their supporters (family and friends). The investigators will use the many health modules that currently exist on the platform for problems like sedentary behaviour, excess body weight, poor sleep, elevated stress and chronic pain. The investigators will continually evaluate the website usage and the program benefits for participants.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Steven Grover, MD
- Número de telefone: 514-791-5688
- E-mail: steven.grover@mcgill.ca
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria: Must be:
- Canadian Woman Veteran or
- Family Member of a Canadian Women Veteran or
- Friend of a Canadian Women Veteran
Exclusion Criteria:
-
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: online web-based health promotion
Online web-based health promotion program to increase physical activity.
Participants will also learn and practice other healthy lifestyle habits to improve physical and mental health.
|
Online web-based health promotion program to increase physical activity.
Participants will also learn and practice other healthy lifestyle habits to improve physical and mental health.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Program Completion Rates
Prazo: Each Mission lasts 6-12 weeks
|
Program completion rates (%) for each 6-12 week health program (Mission) defined as completing the assessments at baseline and following the 6-12 week intervention
|
Each Mission lasts 6-12 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Impact of the Online Wellness Missions on Body Weight
Prazo: Each intervention lasts 6-12 weeks
|
change in body weight (lbs) between baseline and completion of the intervention
|
Each intervention lasts 6-12 weeks
|
|
Change in Sleep Quality and Chronic Pain
Prazo: Each Mission lasts between 6 and 12 weeks
|
Change in sleep quality and chronic pain (PROMIS 29 Questionnaire) measured at baseline and following completion of the intervention (Mission)
|
Each Mission lasts between 6 and 12 weeks
|
|
Change in Stress Level
Prazo: Each intervention lasts 6-12 weeks
|
Change in stress level (PROMIS Perceived Stress scale) between baseline and completion of intervention
|
Each intervention lasts 6-12 weeks
|
|
Change in Perceived Social Isolation
Prazo: Each Mission lasts 6-12 weeks
|
Change in Perceived Social isolation (PROMIS Social Isolation Short Form 4a) between baseline and completion of intervention (Mission).
|
Each Mission lasts 6-12 weeks
|
|
Login Days
Prazo: Each Mission lasts between 6 and 12 weeks.
|
Number of days that participant logs into the website between the beginning and end of each intervention (Mission).
|
Each Mission lasts between 6 and 12 weeks.
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Steven Grover, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Women Veteran's Health
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .