Vitality Training - evaluation of a group learning intervention for patients with rheumatic diseases

ISRCTN	ISRCTN09062503
DOI	https://doi.org/10.1186/ISRCTN09062503
Secondary identifying numbers	1.2006.3527

Submission date: 11/07/2007
Registration date: 13/08/2007
Last edited: 29/10/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Kare Birger Hagen
Scientific

National Resource Center for Rehabilitation in Rheumatology
Diakonhjemmet Hospital
P.B. 23
Vinderen
Oslo
0592
Norway

Phone	+47 22454855
Email	kbh@ulrik.uio.no

Study information

Study design	1. Pilot study: prospective one year follow-up study (2003 to 2005) 2. Main study: randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Quality of life
Scientific title	Vitality Training - evaluation of a group learning intervention for patients with rheumatic diseases
Study acronym	VTP (Vitality Training Program)
Study objectives	Participation in the Vitality Training Program will improve psychological wellbeing, coping and health related consequences of rheumatic diseases. Please note that details pertaining to the pilot study only will be mentioned in the relevant fields with the title 'Pilot study', and details pertaining only to the main study will be mentioned with the title 'Main study'.
Ethics approval(s)	1. Pilot study: the pilot study was approved by the ethics committee on the 21st March 2001 (ref: 117-01041) with an extended approval to September 2002 (ref: 392-02-01041). 2. Main study: the National Committee for Medical Ethics in Norway approved this study on the 19th December 2006 (ref: 744-06316 1.2006.3527).
Health condition(s) or problem(s) studied	Rheumatic diseases
Intervention	Vitality Training is a ten-session program taught in groups with eight to ten participants. The whole program lasts for approximately four months with a booster session six months after the end of the program. Each session, lasting for four hours, addresses a specific theme, like: if the body could talk.., relation to self and others, what gives and take energy, anger, joy, sorrow and values and choices. Through participation-based teaching and counseling methods patients are invited to become more aware of the relationship beween thoughts, feelings and bodily reactions, and further to explore own resources and potentials; with the emphasis on coping with current life situation. Exercises include awareness and relaxation training, guided imagery, moving to music, creative drawing, use of metaphors, free writing, sharing and listening to one other in small groups and homework.
Intervention type	Other
Primary outcome measure	1. Psychological Distress (General Health Questionnaire 20), this will be measured repeatedly five times before the intervention, five times after the intervention and five times one year after the intervention 2. Self-Efficacy (Arthritis Self-Efficacy Scale), this will be measured one time before the intervention (baseline), one time immediately after the intervention and at one year follow-up (12 months after baseline) 3. Emotional Approach Coping (Emotional Approach Coping Scale), this will be measured one time before the intervention (baseline), one time immediately after the intervention and at one year follow-up (12 months after baseline)
Secondary outcome measures	Symptoms: pain, fatigue, disease activity (Visual Analogue Score [VAS]-scales), this will be measured repeatedly five times before the intervention, five times after the intervention and five times one year after the intervention. Additionally, patient characteristics of age, gender, civil status, work status, diagnosis, disease duration, drug use and use of health care will be collected at baseline. All data will be collected by self-reported questionnaires.
Overall study start date	30/04/2007
Completion date	31/05/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	160
Total final enrolment	73
Key inclusion criteria	1. Pilot study: 1.1. Patients with rheumatic diseases 1.2. Aged 20 to 70 1.3. Minimum disease duration one year 2. Main study: 2.1. Patients with inflammatory rheumatic diseases 2.2. Age 20 to 65 2.3. Minimum disease duration one year
Key exclusion criteria	1. Pilot study: not speaking Norwegian language 2. Main study: 2.1. Not speaking Norwegian language 2.2. Non-inflammatory diagnosis
Date of first enrolment	30/04/2007
Date of final enrolment	31/05/2010

Locations

Countries of recruitment

Norway

Study participating centre

National Resource Center for Rehabilitation in Rheumatology

Oslo
0592
Norway

Sponsor information

National Resource Center for Rehabilitation in Rheumatology (Norway)
Hospital/treatment centre

Diakonhjemmet Hospital
P.B. 23
Vinderen
Oslo
0592
Norway

Phone	+47 22454840
Email	firmapost@nrrk.diakonsyk.no
Website	http://www.nrrk.diakonsyk.no
"ROR"	https://ror.org/02jvh3a15

Funders

Funder type

Hospital/treatment centre

National Resource Center for Rehabilitation in Rheumatology (Norway)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		20/12/2011	29/10/2021	Yes	No

Editorial Notes

29/10/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.