1. This research aims to determine the effect of self-management program on treatment adherence and life satisfaction in patients with multiple sclerosis referred to the Institute for Protection of MS in Zahedan, 2016.
2. Design: This research is a randomized interventional study done on 78 patients with MS. Inclusion criteria include: age over 18; having reading and writing skills; no communication problem (like blindness and deafness). Exclusion criteria: Being in the active phase of the disease 3. Method: The available sampling is done, and then patients are randomly divided to the control and intervention groups.
4) Population: participants including major eligibility criteria: The study populations included patients with multiple sclerosis referred to the Institute for Protection of MS patients and were eligible for the study. The available sampling is done among Multiple sclerosis patients, based on inclusion criteria. 5) Intervention: The control group received routine care. For the intervention group, self-management program is implemented based on five self-management skills, including: 1. Problem-solving skills. 2. Decision-making skills. 3. Use of resources. 4. Formation of therapeutic communication between caregiver and patient. 5. Operational program. Patients in both groups will complete the MS-TAQ treatment and SWLS life satisfaction questionnaires before intervention. In intervention group, self-management sessions will be performed in five sessions of one–and-half-hour , one session a week. 6) Main outcome measures (variables): treatment adherence and life satisfaction.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017082134873N1
Registration date:2017-08-21, 1396/05/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-08-21, 1396/05/30
Registrant information
Name
fariba Yaghoubinia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3343 0059
Email address
yaghoubinia@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Zahedan University of Medical Sciences
Expected recruitment start date
2016-07-10, 1395/04/20
Expected recruitment end date
2016-08-10, 1395/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of a self-management program on treatment adherence and life satisfaction in patients with multiple sclerosis: a clinical trial.
Public title
Impact of self-management program on MS patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria include: age over 18; Having reading and writing skills; No communication problem (like blindness and deafness).
Exclusion criteria: being in the active phase of the disease
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences and Health Services
Street address
University of Medical Sciences, Docter Hesabi square, Zahedan
City
Zahedan
Postal code
9816743463
Approval date
2016-07-10, 1395/04/20
Ethics committee reference number
IR.ZAUMS.REC.1395. 123
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple Sclerosis
Primary outcomes
1
Description
Treatmenet adherence
Timepoint
Before the intervention and two months after the intervention
Method of measurement
MS-TAQ questionnaire
2
Description
Life satisfaction
Timepoint
Before the intervention and two months after the intervention
Method of measurement
SWLS questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
For the intervention group, self-management program is implemented based on five self-management skills, including: 1. Problem-solving skills. 2. Decision-making skills. 3. Use of resources. 4. Formation of therapeutic communication between caregiver and patient. 5. Operational program. Patients in both groups will complete the MS-TAQ treatment and SWLS life satisfaction questionnaires before intervention. In intervention group, self-management sessions will be performed in five sessions of one–and-half-hour , one session a week.
Category
Other
2
Description
The control group received routine care.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Institute for Protection of MS patients in Zahedan