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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ISRCTN |
Last refreshed on:
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7 August 2023 |
Main ID: |
ISRCTN16484746 |
Date of registration:
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21/02/2018 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Improving bereavement outcomes in Zimbabwe
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Scientific title:
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Improving bereavement outcomes in Zimbabwe: a feasibility cluster trial of the 9-cell bereavement tool |
Date of first enrolment:
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01/12/2017 |
Target sample size:
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150 |
Recruitment status: |
Completed |
URL:
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https://www.isrctn.com/ISRCTN16484746 |
Study type:
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Interventional |
Study design:
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Cluster randomised trial (Quality of life)
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Phase:
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Not Applicable
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Countries of recruitment
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Zimbabwe
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Barbara
Mutedzi |
Address:
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9 Bryden Road
Mt Pleasant
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Harare
Zimbabwe |
Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Previous research indicated that interventions were more effective when administered closer (though not too soon) to the time of death of the loved one (Jordan & Neimeyer 2003:765; Allumbaugh & Hoyt 1999 in Jordan & Neimeyer 2003). Additionally, research suggests that six (6) to 18 months is a suitable period for administering bereavement interventions inclusive of their follow up (Jordan & Neimeyer 2003:774.) According to Jenny Hunt, the developer of the 9-cell bereavement tool, the 6-month mark usually represents a time when social support often fades and the reality of the loss sets in.
Inclusion criteria for trial participants will therefore be: 1. Individuals in the community who have experienced the loss of a loved one in the past 6 months from the recruitment date (even where someone has been bereaved within a week of the study, by the time the study is finished it will be over 9 months, so they theoretically are still eligible as 6 to 18 months is a suitable period for administering interventions inclusive of their follow up as indicated above) 2. They will be selected to represent a cross-section of the whole adult community, defined as: 2.1. Being 18 years and above 2.2. Equally representative of both male and female where possible 2.3. Represent all ages above the age of majority, i.e. 18 years of age 2.4. Have the ability to either verbally consent or be able to consent in writing 2.5. Have the ability to attend and participate in the study, preferably for the duration
Inclusion criteria for interventionists: 1. Individuals in the community recruited by community leaders 2. 18 years and above 3. Representatiove of both male and female where possible 4. Have the ability to either verbally consent or be able to consent in writing 5. Have the ability to attend and participate in the study, preferable for the duration
Exclusion criteria: Exclusion criteria for trial participants: 1. Members of the community who have not reached the age of 18 (It is acknowledged that there is a growing need to address the grief and bereavement challenges that young people experience, with the large numbers of single and double orphaned children on the continent, however this is currently beyond the scope of this feasibility study) 2. Those who have not been bereaved in the past 6 months or over 18 months 3. Those unable to physically attend and participate in the study
Exclusion criteria for interventionists 1. Aged below 18 2. Physically unable to attend and participate in the study
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Bereavement Not Applicable
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Intervention(s)
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The 9-cell bereavement tool is a community-based tool, working with and educating families and communities to provide support afforded by bereavement counseling and community whose current structures are unable to reach all people. Through Jennifer Hunt’s work, it is appreciated that grief is best expressed within and supported by family and community. The tool uses wisdom inherent in societies to support individuals and families in crisis. It is a highly personal experience yet played out within one’s culture, which has been traditionally viewed as supportive and communal as opposed to individualized. It adds knowledge to individuals who interact with it, revealing processes that individuals go through with regard to grief.
The research location will be Chitungwiza in Zimbabwe. As the study will consist of both an intervention and a control group for comparative purposes, two neighborhoods within Chitungwiza have been selected; one as the intervention and the other as the control group. Two homogenous neighborhoods within Chitungwiza have been selected to allow for comparative analysis. The two communities selected within Chitungwiza are namely St Mary’s and Seke Unit M. They are homogenous in terms of having the same socio-demographic characteristics and value systems.
It must be emphasized however, that though St Mary’s and Seke are seemingly homogenous, participants will be from diverse backgrounds with respect to age, type of employment, types of bereavement they may have gone through, education, different experiences and religions. The 9-cell bereavement tool accommodates for this as it specifically targets and accommodates difference and uniqueness, and moves away from a concept of homogeneity within a seemingly homogenous group because of the different grief
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Primary Outcome(s)
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Measuring the effectiveness of the 9-cell bereavement tool by collecting baseline, midline (at 3 months) and endline data (6 months) of an intervention group (who receive the intervention at the beginning of the trial) and a control group (who receive the intervention at the end of the study). To measure results at baseline, midline and endline of each group (control and intervention) the following tools and their corresponding measures will be used: 1. Mental health, measured using the Shona Symptom Questionnaire (SSQ) 2. Social support, measured using the MOS Modified Social Support Survey (MSSS) 3. Levels of grief per individual, measured using the Texas Revised Inventory of Grief (TRIG)
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Secondary Outcome(s)
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1. The feasibility of finding 3 participants which the participants know of and whom have been bereaved in the past 6 months within their communities, assessed with a focus group discussion 2. The quality of the interventionists' interactions with the beneficiaries and what changes they noticed in their beneficiaries from their interaction with them after the intervention. Questions also focus on what worked and what didn’t work, what challenges they faced, the support they need moving forward, how they used the intervention and when. Assessed with a focus group discussion at the end of midline data collection 3. The feasibility of retaining engagement with the bereaved in their communities throughout the duration of the study, assessed using a focus group discussion at endline 4. How and if the intervention was delivered as intended, assessed with focus group discussions at midline and endline 5. The trial participants' experience of the intervention, assessed with a focus group discussion
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Secondary ID(s)
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MRCZ/A/2230
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Source(s) of Monetary Support
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BuildCARE (Building Capacity, Access, Rights and Empowerment) (UK)
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Ethics review
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Status:
Approval date:
Contact:
Old ethics approval format; Medical Research Council of Zimbabwe (MRCZ), re: MRCZ/A/2230 - approval pending
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Results
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Results available:
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Yes |
Date Posted:
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Date Completed:
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30/06/2018 |
URL:
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