Concentrated Cross-disciplinary Group Intervention for Common Health Complaints (Including Post COVID-19 Fatigue)

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Concentrated Cross-disciplinary Group Intervention for Common Health Complaints (Mixed Anxiety Depression, Diabetes Mellitus Type 2, Low Back Pain, Chronic Obstructive Pulmonary Disease and Post COVID-19 Fatigue)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05234281
• Other study ID #: 2020/101648
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: May 1, 2024

Study information

• Verified date: July 2022
• Source: Helse i Hardanger
• Contact: Eirik Søfteland, PhD
• Phone: +47 56 12 60 66
• Email: eirik.softeland.med[@]helse-bergen.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The health care is faced by a growing challenge in the years to come: increasing age and chronic morbidity raising the costs, combined with decreased work participation. Among the conditions on the rise, we find anxiety/depression, musculoskeletal conditions, type 2 diabetes and chronic obstructive pulmonary disease. Recently, the rise of the Corona pandemic has yielded another group of (primarily young) patients with decreased work capacity, the post-Covid syndrome sufferers.

The aim of the present study is to establish, describe and summarize the experiences with a novel approach to rehabilitation for five of the most costly conditions; 1) low back pain, 2) chronic obstructive pulmonary disease, 3) type 2 diabetes mellitus, 4) mixed anxiety/depression and 5) post-Covid fatigue.

The concentrated interdisciplinary rehabilitation is characterised by three phases;

1. Pre-intervention preparation (1-2 months): with the aim to mobilize the patients' resources for change

2. Concentrated group intervention (2-5 days): interdisciplinary team - individually tailored training (further described below)

3. Post-intervention follow-up (1 year): digital follow-up with the aim of integrate the changes into everyday living

The concentrated intervention:

The core intervention is based on trans-diagnostic features of the highly successful 4-day intervention for Obsessive Compulsive Disorder, namely:

• Initiate treatment when the patient is ready for change

• Focus on the behavioral patterns which maintain the disorder and help the patient to identify situations where they can choose to break the pattern ("micro-choices").

• Assist the patient when they practice breaking the patterns. This may pertain to how they do physical training or to the way they walk, sit, eat, talk, take their medication and sleep, or to how they engage in social activities or take care of others.

• Use long sessions to ensure that they face a broad range of potential micro-choices

• Work side-by side with others going through an analogous pattern of change

• Prepare them for taking responsibility for integrating the change into every-day living

Main outcomes will be

1. Completion rates

2. Patient satisfaction

3. Changes to perception of illness

4. Patient activation

Secondary outcomes will be

1. Level of functioning

2. Qualitative description of participants' experiences

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Competent to consent

• Motivated to participate throughout the project

• Digital competence

Exclusion Criteria:

• Medical conditions that could preclude proper participation

• Unable to take care of everyday needs (nursing requirements)

• Cognitive failure

Related Conditions & MeSH terms

• Back Pain
• Chronic Obstructive Pulmonary Disease
• COVID-19
• Depression
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Low Back Pain
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Interdisciplincary concentrated group rehabilitation
All arms receive a concentrated interdisciplinary rehabilitation with similar focus and structure: Three phases: Pre-intervention preparation (1-2 months): mobilize the patients' resources for change Concentrated group intervention (2-5 days): (further described below) Post-intervention follow-up (1 year): digital follow-up The core intervention is based on the concentrated rehabilitation format: Initiate treatment when the patient is ready for change Focus on the behavioral patterns which maintain the disorder, identify situations where they can break the patterns ("micro-choices"). Assist the patient when breaking the patterns. Use long sessions to ensure that they face a broad range of potential micro-choices Work side-by side with others going through an analogous pattern of change Prepare them for taking responsibility for integrating the change into every-day living

Locations

Country	Name	City	State
Norway	Helse i Hardanger	Øystese

Sponsors (2)

Lead Sponsor	Collaborator
Helse i Hardanger	Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion rates	Percentage of participants who are eligible for participation, who complete the 1 year programme	12 months
Primary	Patient satisfaction	The Client Satisfaction Questionnaire (CSQ-8) is an 8-item questionnaire that measures patient satisfaction with health services, where the items are rated from 1 (very low satisfaction) to 4 (very high satisfaction). The total score ranges from 8-32, with higher scores indicating higher degree of satisfaction. The CSQ-8 has good psychometric properties, with high internal consistency (Cronbach's a = .93), and high inter-item correlation.	1 week post treatment and 12 months
Primary	Changes to cognitive and emotional perception of illness	Changes (absolute levels and %) in cognitive and emotional representations of illness before, 3, 6 and 12 months after the intervention, as measured through the generic questionnaire The Brief Illness Perception Questionnaire (Brief IPQ). This is a 9-item questionnaire designed to assess cognitive and emotional representations of illness. Questions are graded from 1 to 10. The last item deals with perceived cause of illness, in which respondents list the perceived three most important causal factors in their illness. For this questionnaire, the general word 'illness' can be replaced by the name of a particular illness. The word 'treatment' in the treatment control item can be replaced by a particular treatment such as 'surgery' or 'physiotherapy'.	Baseline, 3, 6 and 12 months
Primary	Changes in level of patient activation	Changes (absolute levels and %) in patient activation before, 3, 6 and 12 months after the intervention, as measured through the generic questionnaire Patient Activation Measure (PAM-13). This is the shortened version developed by Hibbard et al in 2005. Each question replied categorically as either disagree strongly, disagree, agree, agree strongly or N/A. These are further scored and summarized, yielding a 0-100 score, where higher score indicates higher degree of patient activation. The questionnaire is widely used, with high internal consistency (Cronbach's a = .91).	Baseline, 3, 6 and 12 months
Secondary	Changes in level of functioning	Changes (absolute levels and %) in level of everyday function before, 3, 6 and 12 months after the intervention, as measured through the generic questionnaire Work and Social Adjustment Scale (WSAS). This short (6 item) questionnaire allows participants to grade their level of functioning on a 9-point scale, ranging from severly impaired to not impaired. The scale is widely used, and according to studies provide high internal consistencies ranging from Cronbach's a 0.70 to 0.94.	Baseline, 3, 6 and 12 months