Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201602001450196 Date of Approval: 03/02/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy of a Multicomponant Psychosocial Interventional Program for Caregivers of Dementia Patients
Official scientific title Efficacy of a multi-component psychosocial intervention program for caregivers of dementia patients, Alexandria, Egypt: A randomized controlled trial
Brief summary describing the background and objectives of the trial Considering the expected increase in the Egyptian elderly population during the coming years, with scarcity of studies investigating the burden of caregiving of demented patients, it is greatly needed to highlight this gap in our knowledge, and to develop a culturally sensitive psychosocial intervention program for relieving caregiving burden. This trial objectives were: 1- To design and implement a multi-component psychosocial interventional program for a group of caregivers of patients with dementia (psychoeducation, brief group cognitive behavioral therapy (CBT) and group support). 2- To evaluate the impact of the interventional program on the caregivers' emotional status, perceived burden of care and dementia-related knowledge.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mental and Behavioural Disorders,The emotional status, perceived burden of care, dementia-related knowledge
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Psychosocial
Anticipated trial start date 02/04/2012
Actual trial start date 02/04/2012
Anticipated date of last follow up 31/10/2012
Actual Last follow-up date 28/11/2012
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 114
Recruitment status Stopped early/ terminated
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised simple randomisation using a randomistation table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group No intervention 59
Experimental Group A multi-component psychosocial intervention program 8 sessions, one session per week two months A multi-component psychosocial program with three components (psychoeducation, brief group cognitive behavioral therapy (CBT) and group support)2 sessions for psychoeducation, 6 sessions for group CBT and group support was provided throughout all the sessions. Each group consisted of 8-10 caregivers. Each session took 45-60 minutes. Training was conducted through a collaborative approach. 55
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Patients aged 60 years and more, diagnosed with any type of dementia according to DSM-IV-TR, and having a score of less than 20 on the Mini Mental State Examination (MMSE) scale. 2- Informal caregivers currently living with patients (fulfilling the above mentioned criteria) and accepting to give a written consent to participate in the program. 1- Currently or recently (during previous month) hospitalized patients. 2- Patients suffering from severe debilitating disease (terminal stage cancer, completely bed ridden), or communicative problems. 16 Year(s) 78 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 31/01/2012 Ethics Committee at the High Institute of Public Health (HIPH) ¿ Alexandria University
Ethics Committee Address
Street address City Postal code Country
High Institute of Public Health, 165 El-Horreya Avenue Alexandria 21561 Egypt
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes Ethical Committee of General Secretariat Of Mental Health And Addiction Treatment
Ethics Committee Address
Street address City Postal code Country
1 Salah Salem St., Nasr City Cairo Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Caregiver anxiety Immediately after program completion Three months after program completion
Primary Outcome Caregiver dementia-related knowledge Immediately after program completion Three months after program completion
Primary Outcome Caregiver depression Immediately after program completion Three months after program completion
Secondary Outcome Caregiver perceived burden Immediately after program completion Three months after program completion
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
The psychogeriatric clinic of Al-Maamoura Psychiatric Hospital El Nabawy El Mohandes St. Off El Mallaha Rd. El Mandara, Alexandria Alexandria 11843 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
No funding sources.The researcher financed all needed materials
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor High Institute of Public Health - Alexandria University 165 El-Horreya Avenue Alexandria 21561 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mervat W. Abu-Nazel High Institute of Public Health, 165 El-Horreya Avenue Alexandria 21561 Egypt
Zeinab N. Shata High Institute of Public Health, 165 El-Horreya Avenue Alexandria 21561 Egypt
Heba M. El-Kady High Institute of Public Health, 165 El-Horreya Avenue Alexandria 21561 Egypt
Marwa R. Amin Al-Mamoura Hospital, El-Nabawy Al-Mohandes St., Al-Malaha, Al-Montazah Alexandria 11843 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Marwa Amin marwarefaat01@yahoo.com 00966580404148
City Postal code Country Position/Affiliation
Al-Taif Saudi Arabia Psych Consult Al-Maamoura Psych Hosp Alexandria, Egypt. Al-Hada Military Hosp Al-Taif
Role Name Email Phone Street address
Public Enquiries Zeinab Shata Zeinab.Shata@yahoo.com 00966582233791
City Postal code Country Position/Affiliation
Jazan Saudi Arabia Lecturer High Institute Pub Health Egypt. Assis Prof Faculty Pub Health Trop Med, Saudi Arabia
Role Name Email Phone Street address
Scientific Enquiries Zeinab Shata Zeinab.Shata@yahoo.com 00966582233791
City Postal code Country Position/Affiliation
Jazan Saudi Arabia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information